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A Study to Test the Addition of the Drug Cabozantinib to Chemotherapy in Patients With Newly Diagnosed Osteosarcoma
ctrrecruit@vcu.edu
NCT05691478
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Inclusion Criteria:
* Patients must be \< 40 years of age at the time of enrollment.
* Patients must have a body surface area of \>= 0.8 m\^2 at the time of enrollment.
* Patients must have histologic diagnosis (by institutional pathologist) of newly diagnosed high grade osteosarcoma. Primary tumors of all extremity and axial sites are eligible as long as diagnosis of high-grade osteosarcoma is established. Osteosarcoma as a second malignancy is eligible if no prior exposure to systemic chemotherapies.
* Feasibility Phase (NOTE: as of Amendment #2B, the feasibility phase has been completed) Patients must have metastatic disease and a resectable primary tumor. Designation of a primary tumor as resectable will be determined at the time of diagnosis by the institutional multidisciplinary team.
For this study, metastatic disease is defined as one or more of the following:
* Lesions which are discontinuous from the primary tumor, are not regional lymph nodes, and do not share a bone or body cavity with the primary tumor. Skip lesions in the same bone as the primary tumor do not constitute metastatic disease. Skip lesions in an adjacent bone are considered bone metastases.
* Lung metastases: defined as biopsy-proven metastasis or the presence of one or more pulmonary lesions \>= 5 mm, OR multiple pulmonary lesions \>= 3 mm or greater in size.
* Bone metastases: Areas suspicious for bone metastasis based on fludeoxyglucose F-18 (18F-FDG)-positron emission tomography (PET) scan (or whole body technetium-99 bone scan if 18F-FDG-PET is unavailable at the treating institution) require confirmatory biopsy or supportive anatomic imaging of at least one suspicious site with either magnetic resonance imaging (MRI) or computed tomography (CT) (whole body 18F-FDG-PET/CT or 18F-FDG-PET/MR scans are acceptable).
* Efficacy Phases (Phase 2/3) NOTE: as of Amendment #2B, the efficacy phase is open for enrollment.
Patients with both localized and metastatic disease are eligible for the efficacy phase, regardless of resectability. Patients will be enrolled to two separate cohorts:
* Cohort 1 (Standard Risk): Patients with non-pelvic primary osteosarcoma deemed to be resectable at the time of diagnosis by the institutional multidisciplinary team, without evidence of metastatic lesions.
* Cohort 2 (High-Risk): Patients with a primary pelvic tumor, a primary tumor designated as unresectable by the institutional multidisciplinary team, AND/OR radiographic evidence of metastatic lesions.
* A serum creatinine based on age/sex as follows (within 7 days prior to enrollment unless otherwise indicated):
* (Age: Maximum Serum Creatinine \[mg/dL\]; Sex)
* 1 month to \< 6 months: 0.4 (male); 0.4 (female)
* 6 months to \< 1 year: 0.5 (male); 0.5 (female)
* 1 to \< 2 years: 0.6 (male); 0.6 (female)
* 2 to \< 6 years: 0.8 (male); 0.8 (female)
* 6 to \< 10 years: 1 (male); 1 (female)
* 10 to \< 13 years: 1.2 (male); 1.2 (female)
* 13 to \< 16 years: 1.5 (male); 1.4 (female)
* \>= 16 years: 1.7 (male); 1.4 (female)
* OR - a 24 hour urine creatinine clearance \>= 70 mL/min/1.73 m\^2
* OR - a glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2. GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard).
* Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility.
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment unless otherwise indicated)
* Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 135 U/L (within 7 days prior to enrollment unless otherwise indicated)
* Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L
* No history of congenital prolonged corrected QT (QTc) syndrome, New York Heart Association (NYHA) Class III or IV congestive heart failure, unstable angina pectoris, serious cardiac arrhythmias
* Shortening fraction of \>= 27%, or
* Ejection fraction of \>= 50%
* Corrected QT interval by Fridericia (QTcF) \< 480 msec on electrocardiogram. Patients with Grade 1 prolonged QTc (450-480 msec) at time of study enrollment should have correctable causes of prolonged QTc addressed if possible (i.e., electrolytes, medications).
* Peripheral absolute neutrophil count (ANC) \>= 1000/uL (within 7 days prior to enrollment unless otherwise indicated)
* Platelet count \>= 100,000/uL (transfusion independent, defined as not receiving platelet transfusions within a 7-day period prior to enrollment) (within 7 days prior to enrollment unless otherwise indicated)
* Hemoglobin \>= 8.0 g/dL (within 7 days prior to enrollment unless otherwise indicated)
* International normalized ratio (INR) =\< 1.5 (within 7 days prior to enrollment unless otherwise indicated)
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible as long as they are NOT receiving anti-retroviral agents that are strong inhibitors or inducers of CYP3A4, CYP2D6, and/or MRP2 transporter protein.
* All patients and/or their parents or legal guardians must sign a written informed consent.
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.
Exclusion Criteria:
* Patients who have received previous systemic therapy for osteosarcoma or a prior oncologic diagnosis.
* Patients who have central nervous system metastases.
* Patients with central cavitating pulmonary lesions invading or encasing any major blood vessels in the lung.
* Patients who are unable to swallow tablets. Tablets cannot be crushed or chewed.
* Patients with gastrointestinal disorders including active disorders associated with a high risk of perforation or fistula formation. Specifically, no clinically significant gastrointestinal (GI) bleeding, GI perforation, bowel obstruction, intra-abdominal abscess or fistula for 6 months prior to enrollment, no hemoptysis or other signs of pulmonary hemorrhage for 3 months prior to enrollment.
* Patients with active bleeding or bleeding diathesis. No clinically significant hematuria, hematemesis, or hemoptysis or other history of significant bleeding within 3 months prior to enrollment.
* Patients with uncompensated or symptomatic hypothyroidism. Patients who have hypothyroidism controlled with thyroid replacement hormone are eligible.
* Patients with moderate to severe hepatic impairment (Child-Pugh B or C).
* Patients who have had primary tumor resection or attempted curative resection of metastases prior to enrollment.
* Patients who have undergone other major surgical procedure (eg, laparotomy) within 14 days prior to enrollment. Thoracoscopic procedures for diagnostic purposes (biopsy of lung nodule) and central access such as port-a-cath placement are allowed.
* Patients with a history of serious or non-healing wound or bone fracture (pathologic fracture of primary tumor is not considered exclusion).
* Patients with any medical or surgical conditions that would interfere with gastrointestinal absorption of cabozantinib.
* Patients with previously identify allergy or hypersensitivity to components of the study treatment formulations.
* Patients who are receiving any other investigational agent not defined within this protocol are not eligible.
* Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible.
* Patients who received enzyme-inducing anticonvulsants within 14 days prior to enrollment.
* Patients with a prior history of hypertension (\> 95th percentile for age, height, and sex for patients \< 18 years and \> 140/90 mmHg for patients \>= 18 years requiring medication for blood pressure control.
* Patients who are receiving drugs that prolong QTc.
* Patients receiving anticoagulation with oral coumarin agents (eg warfarin), direct thrombin inhibitors (eg dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (eg, clopidogrel). Low dose aspirin for cardioprotection (per local applicable guidelines) and low dose, low molecular weight heparins (LMWH) are permitted. Anticoagulation with therapeutic doses of LMWH and direct factor Xa inhibitors rivaroxaban or apixaban are allowed in subjects who are on a stable dose for at least 6 weeks before the first dose of study treatment, and who have had no complications from a thromboembolic event or the anticoagulation regimen.
* Patients receiving strong CYP3A4 inducers or strong CYP3A4 inhibitors.
* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.
* Lactating females who plan to breastfeed their infants.
* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of protocol therapy. PROCEDURE: Bone Scan, DRUG: Cabozantinib S-malate, DRUG: Cisplatin, PROCEDURE: Computed Tomography, DRUG: Doxorubicin Hydrochloride, PROCEDURE: Magnetic Resonance Imaging, DRUG: Methotrexate, PROCEDURE: Surgical Procedure, PROCEDURE: X-Ray Imaging
High Grade Osteosarcoma, Localized Osteosarcoma, Metastatic Osteosarcoma, Secondary Osteosarcoma
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Show 155 locations
Study Locations
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| Location | Contacts |
|---|---|
| AdventHealth Orlando Orlando, Florida | Site Public Contact - (FH.Cancer.Research@flhosp.org) |
| Albany Medical Center Albany, New York | |
| Alberta Children's Hospital Calgary, Alberta | |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.org) |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Arnold Palmer Hospital for Children Orlando, Florida | Site Public Contact - (Jennifer.spinelli@orlandohealth.com) |
| Augusta University Medical Center Augusta, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| C S Mott Children's Hospital Ann Arbor, Michigan | |
| CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) Québec, | |
| CancerCare Manitoba Winnipeg, Manitoba | |
| Cardinal Glennon Children's Medical Center St Louis, Missouri | |
| Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec | |
| Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec | |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia | Site Public Contact - (Olivia.Floyd@choa.org) |
| Children's Hospital London, Ontario | |
| Children's Hospital Colorado Aurora, Colorado | Site Public Contact - (josh.b.gordon@nsmtp.kp.org) |
| Children's Hospital Los Angeles Los Angeles, California | |
| Children's Hospital Medical Center Of Akron Akron, Ohio | |
| Children's Hospital Of Eastern Ontario Ottawa, Ontario | |
| Children's Hospital and Medical Center of Omaha Omaha, Nebraska | |
| Children's Hospital of Alabama Birmingham, Alabama | Site Public Contact - (oncologyresearch@peds.uab.edu) |
| Children's Hospital of Michigan Detroit, Michigan | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Orange County Orange, California | Site Public Contact - (oncresearch@choc.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Site Public Contact - (CancerTrials@email.chop.edu) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Site Public Contact - (jean.tersak@chp.edu) |
| Children's Hospital of San Antonio San Antonio, Texas | Site Public Contact - (bridget.medina@christushealth.org) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | Site Public Contact - (MACCCTO@mcw.edu) |
| Children's Hospital of the King's Daughters Norfolk, Virginia | Site Public Contact - (CCBDCresearch@chkd.org) |
| Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota | Site Public Contact - (pauline.mitby@childrensmn.org) |
| Children's Mercy Hospitals and Clinics Kansas City, Missouri | Site Public Contact - (rryan@cmh.edu) |
| Children's National Medical Center Washington D.C., District of Columbia | Site Public Contact - (OncCRC_OnCall@childrensnational.org) |
| Christchurch Hospital Christchurch, | |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@cchmc.org) |
| City of Hope Comprehensive Cancer Center Duarte, California | Site Public Contact - (becomingapatient@coh.org) |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Connecticut Children's Medical Center Hartford, Connecticut | |
| Cook Children's Medical Center Fort Worth, Texas | Site Public Contact - (CookChildrensResearch@cookchildrens.org) |
| Corewell Health Children's Royal Oak, Michigan | |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Covenant Children's Hospital Lubbock, Texas | Site Public Contact - (mbisbee@providence.org) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Dayton Children's Hospital Dayton, Ohio | |
| Dell Children's Medical Center of Central Texas Austin, Texas | Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org) |
| Duke University Medical Center Durham, North Carolina | |
| East Carolina University Greenville, North Carolina | Site Public Contact - (eubankss@ecu.edu) |
| East Tennessee Childrens Hospital Knoxville, Tennessee | |
| El Paso Children's Hospital El Paso, Texas | Site Public Contact - (ranjan.bista@ttuhsc.edu) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Golisano Children's Hospital of Southwest Florida Fort Myers, Florida | Site Public Contact - (molly.arnstrom@leehealth.org) |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Hospital for Sick Children Toronto, Ontario | |
| IWK Health Centre Halifax, Nova Scotia | |
| Jim Pattison Children's Hospital Saskatoon, Saskatchewan | |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kaiser Permanente Downey Medical Center Downey, California | |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Loma Linda University Medical Center Loma Linda, California | |
| Lucile Packard Children's Hospital Stanford University Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| Lurie Children's Hospital-Chicago Chicago, Illinois | |
| M D Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| Madigan Army Medical Center Tacoma, Washington | Site Public Contact - (melissa.a.forouhar.mil@health.mil) |
| Maine Children's Cancer Program Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | |
| Mary Bridge Children's Hospital and Health Center Tacoma, Washington | Site Public Contact - (research@multicare.org) |
| Mattel Children's Hospital UCLA Los Angeles, California | |
| Medical City Dallas Hospital Dallas, Texas | |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (OHR@mhs.net) |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Methodist Children's Hospital of South Texas San Antonio, Texas | Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com) |
| Miller Children's and Women's Hospital Long Beach Long Beach, California | |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Morristown Medical Center Morristown, New Jersey | |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York | Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu) |
| NYP/Weill Cornell Medical Center New York, New York | |
| NYU Langone Hospital - Long Island Mineola, New York | Site Public Contact - (cancertrials@nyulangone.org) |
| Nationwide Children's Hospital Columbus, Ohio | Site Public Contact - (Melinda.Triplet@nationwidechildrens.org) |
| Nemours Children's Clinic-Jacksonville Jacksonville, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| Nemours Children's Hospital Orlando, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| New York Medical College Valhalla, New York | |
| Newark Beth Israel Medical Center Newark, New Jersey | Site Public Contact - (Christine.Kosmides@rwjbh.org) |
| Nicklaus Children's Hospital Miami, Florida | |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| Norton Children's Hospital Louisville, Kentucky | Site Public Contact - (CancerResource@nortonhealthcare.org) |
| Novant Health Presbyterian Medical Center Charlotte, North Carolina | Site Public Contact - (kashah@novanthealth.org) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Penn State Children's Hospital Hershey, Pennsylvania | |
| Perth Children's Hospital Perth, Western Australia | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Primary Children's Hospital Salt Lake City, Utah | |
| Prisma Health Richland Hospital Columbia, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington | Site Public Contact - (HopeBeginsHere@providence.org) |
| Queensland Children's Hospital South Brisbane, Queensland | |
| Rady Children's Hospital - San Diego San Diego, California | |
| Rainbow Babies and Childrens Hospital Cleveland, Ohio | |
| Riley Hospital for Children Indianapolis, Indiana | |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado | Site Public Contact - (PSGResearchSharedMailbox@HCAHealthcare.com) |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Royal Children's Hospital Parkville, Victoria | Site Public Contact - (Jordan.Hansford@rch.org.au) |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey | |
| Saint Christopher's Hospital for Children Philadelphia, Pennsylvania | |
| Saint Francis Cancer Center Greenville, South Carolina | Site Public Contact - (Heather_Rich@bshsi.org) |
| Saint Francis Hospital Greenville, South Carolina | Site Public Contact - (Heather_Rich@bshsi.org) |
| Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida | Site Public Contact - (jennifer.manns@baycare.org) |
| Saint Joseph's Regional Medical Center Paterson, New Jersey | Site Public Contact - (HallL@sjhmc.org) |
| Saint Jude Children's Research Hospital Memphis, Tennessee | Site Public Contact - (referralinfo@stjude.org) |
| Saint Jude Midwest Affiliate Peoria, Illinois | |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Seattle Children's Hospital Seattle, Washington | |
| Sinai Hospital of Baltimore Baltimore, Maryland | |
| Starship Children's Hospital Auckland, | |
| State University of New York Upstate Medical University Syracuse, New York | |
| Stony Brook University Medical Center Stony Brook, New York | |
| Summerlin Hospital Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Sydney Children's Hospital Randwick, New South Wales | |
| The Children's Hospital at TriStar Centennial Nashville, Tennessee | |
| The Children's Hospital at Westmead Westmead, New South Wales | |
| The Montreal Children's Hospital of the MUHC Montreal, Quebec | |
| The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York | |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| UCSF Benioff Children's Hospital Oakland Oakland, California | Site Public Contact - (cogbchoak@ucsf.edu) |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UMC Cancer Center / UMC Health System Lubbock, Texas | |
| UMass Memorial Medical Center - University Campus Worcester, Massachusetts | Site Public Contact - (cancer.research@umassmed.edu) |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Florida Health Science Center - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Maryland/Greenebaum Cancer Center Baltimore, Maryland | |
| University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan | Site Public Contact - (slusserb@med.umich.edu) |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Rochester Rochester, New York | |
| University of Texas Health Science Center at San Antonio San Antonio, Texas | Site Public Contact - (phoresearchoffice@uthscsa.edu) |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| VCU Massey Cancer Center at Stony Point Richmond, Virginia | Site Public Contact - (ctoclinops@vcu.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Children's Hospital Madera, California | Site Public Contact - (Research@valleychildrens.org) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| West Virginia University Charleston Division Charleston, West Virginia | |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Collection of Research Data and Samples From Patients Who Experience Immunotherapy Side Effects
David Kozono, MD, PhD - dkozono@bwh.harvard.edu
NCT04242095
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Inclusion Criteria:
* Received a regimen containing one or more immuno-oncology therapeutics
* Must have experienced one or more of the following:
* One or more serious (Grade 3-4) AEs that are likely immune-related
* One or more Grade 2 dermatologic or rheumatologic AEs that are likely immune-related
* Diagnosis of a rare infection, e.g., fungal or mycobacterial, after starting IO treatment
\*\* Note: Diagnosis of SARS-CoV-2 (COVID-19) is excluded
* Hyperprogression. Image submission for patients experiencing hyperprogression is required. For assistance in determining hyperprogression for purposes of eligibility, institutions may contact the study chair and submit images for central review
* Has not previously been registered to this study PROCEDURE: Biospecimen Collection, OTHER: Medical Chart Review
Malignancy
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Show 621 locations
Study Locations
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| Location | Contacts |
|---|---|
| AMG Crystal Lake - Oncology Crystal Lake, Illinois | Site Public Contact - (advocateresearch@advocate.com) |
| AMG Libertyville - Oncology Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Adams Cancer Center Gettysburg, Pennsylvania | |
| Adena Regional Medical Center Chillicothe, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Advanced Breast Care Center PLLC Warren, Michigan | |
| AdventHealth Littleton Littleton, Colorado | |
| AdventHealth Parker Parker, Colorado | |
| AdventHealth Porter Denver, Colorado | |
| Advocate Christ Medical Center Oak Lawn, Illinois | |
| Advocate Good Samaritan Hospital Downers Grove, Illinois | Site Public Contact - (Barbara.barhamand@advocatehealth.com) |
| Advocate Good Shepherd Hospital Barrington, Illinois | |
| Advocate Illinois Masonic Medical Center Chicago, Illinois | |
| Advocate Lutheran General Hospital Park Ridge, Illinois | |
| Advocate Outpatient Center - Aurora Aurora, Illinois | Site Public Contact - (ncorp@aah.org) |
| Advocate Sherman Hospital Elgin, Illinois | |
| Advocate South Suburban Hospital Hazel Crest, Illinois | |
| Alaska Breast Care and Surgery LLC Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Alaska Oncology and Hematology LLC Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Alaska Women's Cancer Care Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Alegent Health Bergan Mercy Medical Center Omaha, Nebraska | |
| Alegent Health Immanuel Medical Center Omaha, Nebraska | |
| Alegent Health Lakeside Hospital Omaha, Nebraska | |
| Alegent Health Mercy Hospital Council Bluffs, Iowa | |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Anchorage Associates in Radiation Medicine Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Anchorage Oncology Centre Anchorage, Alaska | |
| Anchorage Radiation Therapy Center Anchorage, Alaska | |
| Ann M Wierman MD LTD Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Armes Family Cancer Center Findlay, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Ascension All Saints Hospital Racine, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Calumet Hospital Chilton, Wisconsin | Site Public Contact - (AWRI.inquiry@ascension.org) |
| Ascension Columbia Saint Mary's Hospital - Milwaukee Milwaukee, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Columbia Saint Mary's Hospital Ozaukee Mequon, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Medical Group Southeast Wisconsin - Mayfair Road Wauwatosa, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Mercy Hospital Oshkosh, Wisconsin | Site Public Contact - (AWRI.inquiry@ascension.org) |
| Ascension Saint Elizabeth Hospital Appleton, Wisconsin | Site Public Contact - (AWRI.inquiry@ascension.org) |
| Ascension Saint Francis - Reiman Cancer Center Franklin, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Saint Francis Hospital Milwaukee, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Southeast Wisconsin Hospital - Elmbrook Campus Brookfield, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Southeast Wisconsin Hospital - Franklin Franklin, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Southeast Wisconsin Hospital - Saint Joseph Campus Milwaukee, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Aspirus Cancer Care - James Beck Cancer Center Rhinelander, Wisconsin | |
| Aspirus Cancer Care - Stevens Point Stevens Point, Wisconsin | |
| Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Audie L Murphy VA Hospital San Antonio, Texas | |
| Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora BayCare Medical Center Green Bay, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Grafton Grafton, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Kenosha South Kenosha, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Racine Racine, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Health Care Germantown Health Center Germantown, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Medical Center in Summit Summit, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's South Shore Cudahy, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Sinai Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora West Allis Medical Center West Allis, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Avera Cancer Institute Sioux Falls, South Dakota | Site Public Contact - (OncRegulatory@avera.org) |
| BASS Medical Group - Lennon Walnut Creek, California | Site Public Contact - (brenna.lindsey@bassmedicalgroup.com) |
| BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri | |
| Bay Area Breast Surgeons Inc Emeryville, California | |
| Bay Area Hospital Coos Bay, Oregon | Site Public Contact - (cherie.cox@bayareahospital.org) |
| Bay Area Tumor Institute Oakland, California | |
| Beebe Health Campus Rehoboth Beach, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Beebe Medical Center Lewes, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Beebe South Coastal Health Campus Millville, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Beth Israel Deaconess Medical Center Boston, Massachusetts | |
| Bethesda North Hospital Cincinnati, Ohio | |
| Bhadresh Nayak MD PC-Sterling Heights Sterling Heights, Michigan | |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Billings Clinic-Cody Cody, Wyoming | Site Public Contact - (research@billingsclinic.org) |
| Blanchard Valley Hospital Findlay, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Boulder Community Foothills Hospital Boulder, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Brigham and Women's Hospital Boston, Massachusetts | |
| Broadlawns Medical Center Des Moines, Iowa | |
| CARTI Cancer center Little Rock, Arkansas | Site Public Contact - (Research@CARTI.com) |
| CHI Health Good Samaritan Kearney, Nebraska | |
| CHI Health Saint Francis Grand Island, Nebraska | |
| CHI Saint Vincent Cancer Center Hot Springs Hot Springs, Arkansas | |
| Cambridge Medical Center Cambridge, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Camden Clark Medical Center Parkersburg, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Cancer Care Associates of York York, Pennsylvania | |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Center at Saint Joseph's Phoenix, Arizona | |
| Cancer Center of Western Wisconsin New Richmond, Wisconsin | Site Public Contact - (mmcorc@healthpartners.com) |
| Cancer Hematology Centers - Flint Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Cancer and Blood Specialists-Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Cancer and Blood Specialists-Shadow Las Vegas, Nevada | |
| Cancer and Blood Specialists-Tenaya Las Vegas, Nevada | |
| Carle BroMenn Medical Center Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Cancer Institute Normal Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Caro Cancer Center Caro, Michigan | |
| CaroMont Regional Medical Center Gastonia, North Carolina | |
| Carson Tahoe Regional Medical Center Carson City, Nevada | Site Public Contact - (research@sncrf.org) |
| Central Care Cancer Center - Bolivar Bolivar, Missouri | Site Public Contact - (aroland@kccop.org) |
| Central Care Cancer Center - Garden City Garden City, Kansas | Site Public Contact - (aroland@kccop.org) |
| Central Care Cancer Center - Great Bend Great Bend, Kansas | Site Public Contact - (aroland@kccop.org) |
| Central Ohio Breast and Endocrine Surgery Gahanna, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Centralia Oncology Clinic Centralia, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Chambersburg Hospital Chambersburg, Pennsylvania | Site Public Contact - (protocols@AllianceNCTN.org) |
| Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Christiana Care - Union Hospital Elkton, Maryland | Site Public Contact - (frank.crum@christianacare.org) |
| Christiana Care Health System-Christiana Hospital Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Christiana Care Health System-Concord Health Center Chadds Ford, Pennsylvania | Site Public Contact - (lbarone@christianacare.org) |
| Christiana Care Health System-Wilmington Hospital Wilmington, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@cchmc.org) |
| Clackamas Radiation Oncology Center Clackamas, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center Wilmington, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Coborn Cancer Center at Saint Cloud Hospital Saint Cloud, Minnesota | Site Public Contact - (coborncancercenter@centracare.com) |
| Colorado Blood Cancer Institute Denver, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Columbus Oncology and Hematology Associates Dublin, Ohio | |
| Columbus Oncology and Hematology Associates Inc Columbus, Ohio | |
| CommonSpirit Cancer Center Mercy Durango, Colorado | |
| Commonwealth Cancer Center-Corbin Corbin, Kentucky | |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Toms River, New Jersey | Site Public Contact - (mccinfo@mtcancer.org) |
| Comprehensive Cancer Centers of Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Northwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Town Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Condell Memorial Hospital Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Contra Costa Regional Medical Center Martinez, California | |
| Cox Cancer Center Branson Branson, Missouri | |
| CoxHealth South Hospital Springfield, Missouri | |
| Creighton University Medical Center Omaha, Nebraska | |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dayton Physician LLC - Englewood Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Dayton Physicians LLC - Troy Troy, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Dayton Physicians LLC-Atrium Franklin, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Dayton Physicians LLC-Miami Valley South Centerville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Dayton Physicians LLC-Wayne Greenville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Delaware Clinical and Laboratory Physicians PA Newark, Delaware | |
| Delaware Health Center-Grady Cancer Center Delaware, Ohio | |
| Desert West Surgery Las Vegas, Nevada | |
| Doctors Hospital Columbus, Ohio | |
| Dublin Methodist Hospital Dublin, Ohio | |
| Duke Cancer Center Cary Cary, North Carolina | Site Public Contact - (NCTNStudyTeam@dm.duke.edu) |
| Duke Cancer Center Raleigh Raleigh, North Carolina | Site Public Contact - (NCTNStudyTeam@dm.duke.edu) |
| Duke University Medical Center Durham, North Carolina | |
| Duke Women's Cancer Care Raleigh Raleigh, North Carolina | |
| ECU Health Oncology Kenansville Kenansville, North Carolina | Site Public Contact - (research@ecuhealth.org) |
| ECU Health Oncology Kinston Kinston, North Carolina | Site Public Contact - (research@ecuhealth.org) |
| ECU Health Oncology Richlands Richlands, North Carolina | Site Public Contact - (research@ecuhealth.org) |
| East Carolina University Greenville, North Carolina | Site Public Contact - (eubankss@ecu.edu) |
| Ephrata Cancer Center Ephrata, Pennsylvania | |
| Ephrata Community Hospital Ephrata, Pennsylvania | Site Public Contact - (protocols@AllianceNCTN.org) |
| Epic Care Cyberknife Center Walnut Creek, California | |
| Epic Care Partners in Cancer Care Emeryville, California | |
| Epic Care-Dublin Dublin, California | |
| Fairbanks Memorial Hospital Fairbanks, Alaska | Site Public Contact - (Veronica.Stevenson@foundationhealth.org) |
| Fairfield Medical Center Lancaster, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Fairview Clinics and Surgery Center Maple Grove Maple Grove, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Lakes Medical Center Wyoming, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Northland Medical Center Princeton, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Ridges Hospital Burnsville, Minnesota | |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| First Dayton Cancer Care Kettering, Ohio | |
| Flaget Memorial Hospital Bardstown, Kentucky | |
| Franciscan Research Center-Northwest Medical Plaza Tacoma, Washington | |
| Fred Hutchinson Cancer Center Seattle, Washington | |
| Freeman Health System Joplin, Missouri | Site Public Contact - (LJCrockett@freemanhealth.com) |
| Geisinger Cancer Services-Pottsville Pottsville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Geisinger Medical Center-Cancer Center Hazleton Hazleton, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Genesee Hematology Oncology PC Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Genesis Healthcare System Cancer Care Center Zanesville, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| GenesisCare USA - Fort Apache Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| GenesisCare USA - Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| GenesisCare USA - Las Vegas Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| GenesisCare USA - Vegas Tenaya Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Genesys Hurley Cancer Institute Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Good Samaritan Hospital - Cincinnati Cincinnati, Ohio | |
| Grady Memorial Hospital Delaware, Ohio | |
| Grand Valley Oncology Grand Junction, Colorado | Site Public Contact - (gvoclinicaltrials@gjhosp.org) |
| Grant Medical Center Columbus, Ohio | |
| Great Falls Clinic Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Greater Dayton Cancer Center Kettering, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Greater Regional Medical Center Creston, Iowa | |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | Site Public Contact - (cancerctr@gundersenhealth.org) |
| HSHS Saint Elizabeth's Hospital O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo, Washington | |
| Health Partners Inc Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills Las Vegas, Nevada | |
| HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway Las Vegas, Nevada | |
| HealthCare Partners Medical Group Oncology/Hematology-San Martin Las Vegas, Nevada | |
| HealthCare Partners Medical Group Oncology/Hematology-Tenaya Las Vegas, Nevada | |
| Heartland Regional Medical Center Saint Joseph, Missouri | Site Public Contact - (Trisha.England2@mymlc.com) |
| Helen F Graham Cancer Center Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Hematology Oncology Associates of CNY at Camillus Camillus, New York | |
| Hematology Oncology Associates of Central New York-Auburn Auburn, New York | |
| Hematology Oncology Associates of Central New York-East Syracuse East Syracuse, New York | |
| Hematology Oncology Consultants-Clarkston Clarkston, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Hennepin County Medical Center Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Henry Ford Health Providence Novi Hospital Novi, Michigan | |
| Henry Ford Health Providence Southfield Hospital Southfield, Michigan | |
| Henry Ford Health Saint John Hospital Detroit, Michigan | Site Public Contact - (Kkeenan1@hfhs.org) |
| Henry Ford Health Warren Hospital Warren, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Madison Heights Hospital - Breast Warren, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford River District Hospital East China Township, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Rochester Hospital Rochester Hills, Michigan | |
| Henry Ford Saint John Hospital - Academic Grosse Pointe Woods, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Saint John Hospital - Breast Grosse Pointe Woods, Michigan | Site Public Contact - (karen.forman@ascension.org) |
| Henry Ford Saint John Hospital - Macomb Medical Macomb, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Saint John Hospital - Van Elslander Grosse Pointe Woods, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Warren Hospital - Breast Macomb Macomb, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Warren Hospital - GLCMS Warren, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Hi-Line Sletten Cancer Center Havre, Montana | Site Public Contact - (protocols@AllianceNCTN.org) |
| Highline Medical Center-Main Campus Burien, Washington | |
| Holy Cross Hospital Fort Lauderdale, Florida | Site Public Contact - (eileen.georgi@holy-cross.com) |
| Hope Cancer Care of Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Hope Cancer Care of Nevada-Pahrump Pahrump, Nevada | Site Public Contact - (research@sncrf.org) |
| Hope Cancer Center Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Hope Cancer Clinic Livonia, Michigan | |
| Hunterdon Medical Center Flemington, New Jersey | |
| Hurley Medical Center Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Huron Gastroenterology PC Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Idaho Urologic Institute-Meridian Meridian, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Illinois CancerCare - Washington Washington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Bloomington Bloomington, Illinois | |
| Illinois CancerCare-Canton Canton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Carthage Carthage, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Dixon Dixon, Illinois | |
| Illinois CancerCare-Eureka Eureka, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Galesburg Galesburg, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Kewanee Clinic Kewanee, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Macomb Macomb, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Ottawa Clinic Ottawa, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Pekin Pekin, Illinois | |
| Illinois CancerCare-Peoria Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peru Peru, Illinois | |
| Illinois CancerCare-Princeton Princeton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Indu and Raj Soin Medical Center Beavercreek, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Iowa Cancer Specialists Davenport, Iowa | |
| Iowa Lutheran Hospital Des Moines, Iowa | |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| Jefferson Healthcare Port Townsend, Washington | |
| Jewish Hospital Louisville, Kentucky | |
| Jewish Hospital Medical Center South Shepherdsville, Kentucky | |
| Kadlec Clinic Hematology and Oncology Kennewick, Washington | Site Public Contact - (research@kadlecmed.org) |
| Katmai Oncology Group Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Kettering Medical Center Newark, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Kingman Regional Medical Center Kingman, Arizona | Site Public Contact - (research@sncrf.org) |
| Knox Community Hospital Mount Vernon, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| LSU Health Baton Rouge-North Clinic Baton Rouge, Louisiana | Site Public Contact - (research@ololrmc.com) |
| Lafayette Family Cancer Center-EMMC Brewer, Maine | |
| Lake Regional Hospital Osage Beach, Missouri | Site Public Contact - (clinicaltrials@lakeregional.com) |
| Lakeview Hospital Stillwater, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Las Vegas Cancer Center-Henderson Henderson, Nevada | |
| Las Vegas Cancer Center-Medical Center Las Vegas, Nevada | |
| Las Vegas Prostate Cancer Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Cathedral Rock Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Green Valley Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Pebble Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Pecos Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Smoke Ranch Las Vegas, Nevada | Site Public Contact - (research@smcrf.org) |
| Las Vegas Urology - Sunset Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Lehigh Valley Hospital-Hazleton Hazleton, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah, Georgia | |
| Lewistown Hospital Lewistown, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Licking Memorial Hospital Newark, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Logan Health Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Longmont United Hospital Longmont, Colorado | |
| Louisiana State University Health Science Center New Orleans, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| Lourdes Hospital Binghamton, New York | |
| Loyola Center for Health at Burr Ridge Burr Ridge, Illinois | |
| Loyola Medicine Homer Glen Homer Glen, Illinois | |
| Loyola University Medical Center Maywood, Illinois | |
| MU Health Care Goldschmidt Cancer Center Jefferson City, Missouri | |
| Macomb Hematology Oncology PC Warren, Michigan | |
| Margaret R Pardee Memorial Hospital Hendersonville, North Carolina | Site Public Contact - (pardeecancerresearch@unchealth.unc.edu) |
| Marietta Memorial Hospital Marietta, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Marion L Shepard Cancer Center - ECU Health Beaufort Hospital Washington, North Carolina | Site Public Contact - (research@ecuhealth.org) |
| Marjorie Weinberg Cancer Center at Loyola-Gottlieb Melrose Park, Illinois | |
| Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids, Wisconsin | |
| Marshfield Clinic-Chippewa Center Chippewa Falls, Wisconsin | |
| Marshfield Clinic-Wausau Center Wausau, Wisconsin | |
| Marshfield Medical Center - Ladysmith Ladysmith, Wisconsin | |
| Marshfield Medical Center - Minocqua Minocqua, Wisconsin | |
| Marshfield Medical Center - Weston Weston, Wisconsin | |
| Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin | |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | |
| Marshfield Medical Center-Rice Lake Rice Lake, Wisconsin | |
| Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin | |
| Mary Greeley Medical Center Ames, Iowa | |
| Mayo Clinic Hospital in Arizona Phoenix, Arizona | |
| Mayo Clinic in Florida Jacksonville, Florida | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| McFarland Clinic - Ames Ames, Iowa | |
| McFarland Clinic - Boone Boone, Iowa | |
| McFarland Clinic - Jefferson Jefferson, Iowa | |
| McFarland Clinic - Marshalltown Marshalltown, Iowa | |
| McFarland Clinic - Trinity Cancer Center Fort Dodge, Iowa | |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Medical Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Memorial Hospital Marysville, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Memorial Hospital of Carbondale Carbondale, Illinois | Site Public Contact - (clinical.research@sih.net) |
| Memorial Hospital of South Bend South Bend, Indiana | |
| Mercy Cancer Center Merced, California | |
| Mercy Cancer Center - Cape Girardeau Cape Girardeau, Missouri | |
| Mercy Cancer Center - Carmichael Carmichael, California | |
| Mercy Cancer Center - Elk Grove Elk Grove, California | |
| Mercy Cancer Center - Rocklin Rocklin, California | |
| Mercy Cancer Center - Sacramento Sacramento, California | |
| Mercy Cancer Center-West Lakes Clive, Iowa | |
| Mercy Clinic-Rolla-Cancer and Hematology Rolla, Missouri | |
| Mercy Health - Paducah Cancer Center Paducah, Kentucky | Site Public Contact - (BJWarner@mercy.com) |
| Mercy Health - Perrysburg Hospital Perrysburg, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mercy Health - Saint Anne Hospital Toledo, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mercy Health - Saint Vincent Hospital Toledo, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mercy Hospital Fort Smith Fort Smith, Arkansas | |
| Mercy Hospital Joplin Joplin, Missouri | Site Public Contact - (esmeralda.carrillo@mercy.net) |
| Mercy Hospital Oklahoma City Oklahoma City, Oklahoma | |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Mercy Hospital South St Louis, Missouri | Site Public Contact - (Danielle.Werle@mercy.net) |
| Mercy Hospital Springfield Springfield, Missouri | |
| Mercy Hospital Washington Washington, Missouri | |
| Mercy Infusion Center - Chippewa St Louis, Missouri | |
| Mercy Medical Center Springfield, Massachusetts | |
| Mercy Medical Center Springfield, Massachusetts | |
| Mercy Medical Center - Des Moines Des Moines, Iowa | |
| Mercy Medical Center-West Lakes West Des Moines, Iowa | |
| Mercy Oncology and Hematology - Clayton-Clarkson Ballwin, Missouri | |
| Mercy San Juan Medical Center Carmichael, California | |
| MercyOne Genesis Davenport Cancer Center Davenport, Iowa | |
| MercyOne Genesis Davenport Medical Center Davenport, Iowa | |
| MercyOne Genesis Silvis Cancer Center Silvis, Illinois | |
| Methodist Medical Center of Illinois Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Methodist West Hospital West Des Moines, Iowa | |
| Miami Valley Cancer Care and Infusion Greenville, Ohio | |
| Miami Valley Hospital Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital North Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital South Centerville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Michigan Healthcare Professionals Pontiac Pontiac, Michigan | Site Public Contact - (Emily.Crofts@trinity-health.org) |
| Midlands Community Hospital Papillion, Nebraska | |
| Minneapolis VA Medical Center Minneapolis, Minnesota | |
| Minnesota Oncology - Burnsville Burnsville, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande, California | |
| Mission Hope Medical Oncology - Santa Maria Santa Maria, California | |
| Missouri Baptist Medical Center St Louis, Missouri | |
| Missouri Baptist Sullivan Hospital Sullivan, Missouri | |
| Monticello Cancer Center Monticello, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mount Carmel East Hospital Columbus, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mount Carmel Grove City Hospital Grove City, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mount Carmel Health Center West Columbus, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mountain Blue Cancer Care Center - Swedish Englewood, Colorado | |
| MyMichigan Medical Center Alpena Alpena, Michigan | Site Public Contact - (CVResearch@mymichigan.org) |
| MyMichigan Medical Center Gladwin Gladwin, Michigan | Site Public Contact - (CVResearch@mymichigan.org) |
| MyMichigan Medical Center Gratiot Alma, Michigan | Site Public Contact - (CVResearch@mymichigan.org) |
| MyMichigan Medical Center Midland Midland, Michigan | Site Public Contact - (CVResearch@mymichigan.org) |
| MyMichigan Medical Center Mount Pleasant Mount Pleasant, Michigan | Site Public Contact - (CVResearch@mymichigan.org) |
| MyMichigan Medical Center Saginaw Saginaw, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| MyMichigan Medical Center Tawas Tawas City, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York | |
| Nebraska Cancer Specialists/Oncology Hematology West PC Grand Island, Nebraska | |
| Nebraska Medicine-Bellevue Bellevue, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| Nebraska Medicine-Village Pointe Omaha, Nebraska | |
| New Ulm Medical Center New Ulm, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Newark Radiation Oncology Newark, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Newland Medical Associates-Clarkston Clarkston, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Newland Medical Associates-Pontiac Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| North Memorial Medical Health Center Robbinsdale, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| North Shore Medical Center Skokie, Illinois | Site Public Contact - (ctsucontact@westat.com) |
| North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington | Site Public Contact - (Memorial-ClinicalTrials@yvmh.org) |
| NorthShore University HealthSystem-Evanston Hospital Evanston, Illinois | |
| NorthShore University HealthSystem-Glenbrook Hospital Glenview, Illinois | |
| NorthShore University HealthSystem-Highland Park Hospital Highland Park, Illinois | |
| Northwest Medical Specialties PLLC Tacoma, Washington | |
| OSF Saint Anthony Medical Center Rockford, Illinois | |
| OSF Saint Anthony's Health Center Alton, Illinois | |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| OhioHealth Mansfield Hospital Mansfield, Ohio | |
| OhioHealth Marion General Hospital Marion, Ohio | |
| Oncology Hematology Associates of Saginaw Valley PC Saginaw, Michigan | |
| Oncology Hematology Care Inc-Kenwood Cincinnati, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| OptumCare Cancer Care at Charleston Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Fort Apache Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at MountainView Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Seven Hills Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Orion Cancer Care Findlay, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Our Lady of the Lake Medical Oncology Baton Rouge, Louisiana | Site Public Contact - (research@ololrmc.com) |
| Our Lady of the Lake Physician Group Baton Rouge, Louisiana | Site Public Contact - (research@ololrmc.com) |
| Overlake Medical Center Bellevue, Washington | |
| PCR Oncology Arroyo Grande, California | Site Public Contact - (research@sncrf.org) |
| Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo, California | |
| Pacific Gynecology Specialists Seattle, Washington | |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Parkland Health Center - Farmington Farmington, Missouri | |
| PeaceHealth Saint John Medical Center Longview, Washington | Site Public Contact - (kmakin-bond@peacehealth.org) |
| PeaceHealth Saint Joseph Medical Center Bellingham, Washington | |
| PeaceHealth Southwest Medical Center Vancouver, Washington | Site Public Contact - (kmakin-bond@peacehealth.org) |
| PeaceHealth United General Medical Center Sedro-Woolley, Washington | Site Public Contact - (rcrompton@peacehealth.org) |
| Penrose-Saint Francis Healthcare Colorado Springs, Colorado | |
| Phelps Health Delbert Day Cancer Institute Rolla, Missouri | Site Public Contact - (research@phelpshealth.org) |
| Pocono Medical Center East Stroudsburg, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Portland VA Medical Center Portland, Oregon | |
| Pottstown Hospital Pottstown, Pennsylvania | |
| Premier Blood and Cancer Center Dayton, Ohio | |
| Presbyterian - Saint Lukes Medical Center - Health One Denver, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Princeton Community Hospital Princeton, West Virginia | |
| Providence Alaska Medical Center Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Providence Cancer Institute Clackamas Clinic Clackamas, Oregon | |
| Providence Hood River Memorial Hospital Hood River, Oregon | Site Public Contact - (canrsrchstudies@provdience.org) |
| Providence Newberg Medical Center Newberg, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Portland Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Regional Cancer Partnership Everett, Washington | Site Public Contact - (marilyn.birchman@providence.org) |
| Providence Regional Cancer System-Aberdeen Aberdeen, Washington | Site Public Contact - (deidre.dillon@providence.org) |
| Providence Regional Cancer System-Centralia Centralia, Washington | Site Public Contact - (deidre.dillon@providence.org) |
| Providence Regional Cancer System-Lacey Lacey, Washington | Site Public Contact - (deidre.dillon@providence.org) |
| Providence Regional Cancer System-Shelton Shelton, Washington | |
| Providence Regional Cancer System-Yelm Yelm, Washington | |
| Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank, California | Site Public Contact - (Najee.Boucher@providence.org) |
| Providence Saint Mary Regional Cancer Center Walla Walla, Washington | Site Public Contact - (Cheryl.Dodd@providence.org) |
| Providence Saint Vincent Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Veterans Administration Hospital Providence, Rhode Island | |
| Providence Willamette Falls Medical Center Oregon City, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Radiation Oncology Associates Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Radiation Oncology Centers of Nevada Central Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Radiation Oncology Centers of Nevada Southeast Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Redeemer Health Meadowbrook, Pennsylvania | |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Reid Health Richmond, Indiana | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Renown Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Rice Memorial Hospital Willmar, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Ridgeview Medical Center Waconia, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Riverside Methodist Hospital Columbus, Ohio | |
| Rocky Mountain Cancer Centers - Centennial Centennial, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers - Swedish Englewood, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Aurora Aurora, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Boulder Boulder, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Lakewood Lakewood, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Littleton Littleton, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Longmont Longmont, Colorado | Site Public Contact - (ResearchTracking@Centura.Org) |
| Rocky Mountain Cancer Centers-Midtown Denver, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Penrose Colorado Springs, Colorado | |
| Rocky Mountain Cancer Centers-Rose Denver, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Sky Ridge Lone Tree, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Rocky Mountain Cancer Centers-Thornton Thornton, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| Roger Williams Medical Center Providence, Rhode Island | Site Public Contact - (fdallesandro@chartercare.org) |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Rush-Copley Healthcare Center Yorkville, Illinois | Site Public Contact - (Cancer.Research@rushcopley.com) |
| Rush-Copley Medical Center Aurora, Illinois | Site Public Contact - (RCMC_Cancer_Research@rush.edu) |
| SIH Cancer Institute Carterville, Illinois | Site Public Contact - (clinical.research@sih.net) |
| SSM Health Good Samaritan Mount Vernon, Illinois | Site Public Contact - (gayla.hall@ssmhealth.com) |
| SUNY Upstate Medical Center-Community Campus Syracuse, New York | |
| Saint Alphonsus Cancer Care Center-Baker City Baker City, Oregon | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Alphonsus Cancer Care Center-Boise Boise, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Ann's Hospital Westerville, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Saint Anthony Hospital Lakewood, Colorado | |
| Saint Anthony North Hospital Westminster, Colorado | |
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| Saint Charles Health System-Redmond Redmond, Oregon | |
| Saint Clare Hospital Lakewood, Washington | |
| Saint Elizabeth Boardman Hospital Boardman, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Saint Elizabeth Hospital Enumclaw, Washington | |
| Saint Elizabeth Regional Medical Center Lincoln, Nebraska | |
| Saint Elizabeth Youngstown Hospital Youngstown, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Saint Francis Cancer Center Greenville, South Carolina | |
| Saint Francis Cancer Center Greenville, South Carolina | Site Public Contact - (Heather_Rich@bshsi.org) |
| Saint Francis Hospital Greenville, South Carolina | Site Public Contact - (Heather_Rich@bshsi.org) |
| Saint Francis Hospital Greenville, South Carolina | |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Saint Francis Regional Medical Center Shakopee, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint Helena Hospital St. Helena, California | |
| Saint John's Hospital - Healtheast Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint Joseph Hospital Nashua, New Hampshire | |
| Saint Joseph Hospital East Lexington, Kentucky | |
| Saint Joseph London London, Kentucky | |
| Saint Joseph Mount Sterling Mount Sterling, Kentucky | |
| Saint Joseph Radiation Oncology Resource Center Lexington, Kentucky | |
| Saint Joseph Regional Cancer Center Bryan, Texas | |
| Saint Joseph Warren Hospital Warren, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Saint Joseph's Medical Center Stockton, California | |
| Saint Joseph's/Candler - Bluffton Campus Bluffton, South Carolina | |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Meridian Meridian, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Nampa Nampa, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Twin Falls Twin Falls, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Mary Corwin Medical Center Pueblo, Colorado | |
| Saint Mary's Oncology/Hematology Associates of Marlette Marlette, Michigan | |
| Saint Mary's Oncology/Hematology Associates of West Branch West Branch, Michigan | |
| Saint Mary's Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Saint Michael Cancer Center Silverdale, Washington | |
| Saint Patrick Hospital - Community Hospital Missoula, Montana | Site Public Contact - (amy.hanneman@providence.org) |
| Saint Peter's Community Hospital Helena, Montana | |
| Saint Rita's Medical Center Lima, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri | |
| Saints Mary and Elizabeth Hospital Louisville, Kentucky | |
| Sanford Bismarck Medical Center Bismarck, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicTrialsSF@sanfordhealth.org) |
| Sanford Cancer Center Worthington Worthington, Minnesota | |
| Sanford Joe Lueken Cancer Center Bemidji, Minnesota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Medical Center Fargo Fargo, North Dakota | |
| Sanford Roger Maris Cancer Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford South University Medical Center Fargo, North Dakota | |
| Sanford Thief River Falls Medical Center Thief River Falls, Minnesota | |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Sechler Family Cancer Center Lebanon, Pennsylvania | Site Public Contact - (doxenberg@wellspan.org) |
| Singing River Hospital Pascagoula, Mississippi | |
| Siteman Cancer Center at Christian Hospital St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at West County Hospital Creve Coeur, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center-South County St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Skagit Regional Health Cancer Care Center Mount Vernon, Washington | Site Public Contact - (rcccclinicalresearch@skagitvalleyhospital.org) |
| South Carolina Cancer Specialists PC Hilton Head Island, South Carolina | |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Southern Ohio Medical Center Portsmouth, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Southpointe-Sanford Medical Center Fargo Fargo, North Dakota | |
| Southwest Illinois Health Services LLP Swansea, Illinois | |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| Springfield Regional Cancer Center Springfield, Ohio | |
| Springfield Regional Medical Center Springfield, Ohio | |
| State University of New York Upstate Medical University Syracuse, New York | |
| Strecker Cancer Center-Belpre Belpre, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Summerlin Hospital Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Sunrise Hospital and Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Swedish Cancer Institute-Edmonds Edmonds, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Cancer Institute-Issaquah Issaquah, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Covenant Hospital Chicago, Illinois | |
| Swedish Medical Center-Ballard Campus Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Medical Center-Cherry Hill Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Medical Center-First Hill Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| The Carle Foundation Hospital Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| The Don and Sybil Harrington Cancer Center Amarillo, Texas | Site Public Contact - (Gina.Cravey@bsahs.org) |
| The Mark H Zangmeister Center Columbus, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| The Melanoma and Skin Cancer Institute Englewood, Colorado | Site Public Contact - (ryan.weight@theskincancerinstitute.com) |
| The Women's Imaging Center Denver, Colorado | Site Public Contact - (info@westernstatesncorp.org) |
| TidalHealth Nanticoke / Allen Cancer Center Seaford, Delaware | |
| TriHealth Cancer Institute-Anderson Cincinnati, Ohio | |
| TriHealth Cancer Institute-Westside Cincinnati, Ohio | |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Medical Center - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Medical Center - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive, Iowa | |
| UI Healthcare Mission Cancer and Blood - Fort Dodge Fort Dodge, Iowa | |
| UM Baltimore Washington Medical Center/Tate Cancer Center Glen Burnie, Maryland | |
| UM Saint Joseph Medical Center Towson, Maryland | Site Public Contact - (Jeanmarie.downing@umm.edu) |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| United Hospital Center Bridgeport, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Unity Hospital Fridley, Minnesota | |
| University Cancer Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| University Medical Center New Orleans New Orleans, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| University Medical Center of Southern Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| University of Cincinnati Cancer Center-UC Medical Center Cincinnati, Ohio | |
| University of Cincinnati Cancer Center-West Chester West Chester, Ohio | |
| University of Maryland/Greenebaum Cancer Center Baltimore, Maryland | |
| University of Michigan Health - Sparrow Lansing Lansing, Michigan | Site Public Contact - (harsha.trivedi@umhsparrow.org) |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of New Mexico Cancer Center Albuquerque, New Mexico | |
| University of Washington Medical Center - Montlake Seattle, Washington | |
| UofL Health Medical Center Northeast Louisville, Kentucky | |
| Upper Valley Medical Center Troy, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Upstate Cancer Center at Oswego Oswego, New York | Site Public Contact - (McDowelE@upstate.edu) |
| Upstate Cancer Center at Verona Verona, New York | Site Public Contact - (McDowelE@upstate.edu) |
| Urology Specialists of Nevada - Central Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Urology Specialists of Nevada - Green Valley Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Urology Specialists of Nevada - Northwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Urology Specialists of Nevada - Southwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Medical Center Renton, Washington | Site Public Contact - (research@valleymed.org) |
| Valley Radiation Oncology Peru, Illinois | |
| Veterans Affairs Connecticut Healthcare System-West Haven Campus West Haven, Connecticut | |
| Veterans Affairs Loma Linda Healthcare System Loma Linda, California | |
| Vince Lombardi Cancer Clinic - Oshkosh Oshkosh, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Sheboygan Sheboygan, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Two Rivers Two Rivers, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| WVUH-Berkely Medical Center Martinsburg, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Walter Knox Memorial Hospital Emmett, Idaho | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Wayne Hospital Greenville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Welch Cancer Center Sheridan, Wyoming | |
| WellSpan Health-York Cancer Center York, Pennsylvania | |
| WellSpan Health-York Hospital York, Pennsylvania | |
| WellSpan Medical Oncology and Hematology Chambersburg, Pennsylvania | |
| WellSpan Medical Oncology and Hematology Chambersburg, Pennsylvania | |
| West Jefferson Medical Center Marrero, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| West Suburban Medical Center River Forest, Illinois | |
| West Virginia University Healthcare Morgantown, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Western Illinois Cancer Treatment Center Galesburg, Illinois | |
| Wheeling Hospital/Schiffler Cancer Center Wheeling, West Virginia | |
| Woodland Memorial Hospital Woodland, California | |
| Zuckerberg San Francisco General Hospital San Francisco, California | Site Public Contact - (Paul.Couey@ucsf.edu) |
Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis (PRoMPT BOLUS)
Fran L Balamuth, MD PhD MSCE - BalamuthF@chop.edu
NCT04102371
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Inclusion Criteria:
• Males or females age \>2 months to \<18 years
• Clinician concern for septic shock, operationalized as:
• a "positive" ED sepsis alert confirmed by a physician OR
• physician decision to treat for septic shock OR
• a physician diagnosis of septic shock requiring parenteral antibiotics and fluid resuscitation
• Administration of at least one IV/Intraosseous (IO) fluid bolus for resuscitation and additional fluid deemed likely to be necessary to treat poor perfusion, or clinician judgment that \>1 fluid bolus is highly likely to be required. Poor perfusion is defined as physician's judgement of hypotension or abnormal (either "flash" or "prolonged") capillary refill.
• Receipt of ≤40 mL/kg IV/IO total crystalloid fluid prior to randomization
• Parental/guardian permission (informed consent) if time permits; otherwise, Exception from informed consent (EFIC) criteria met
Exclusion Criteria:
• Treating physician judges that patient's condition deems it unsafe to administer either NS or BF (since patients will be equally likely to receive NS or BF at time of study enrollment), including:
• Clinical suspicion for impending brain herniation
• Known hyperkalemia, defined as non-hemolyzed whole blood or plasma/serum potassium \> 6 mEq/L, based on data available at or before patient meets criteria for study enrollment
• Known hypercalcemia, defined as plasma/serum total calcium \>12 mg/dL or whole blood ionized calcium \>1.35 mmol/L, based on data available at or before patient meets criteria for study enrollment
• Known acute fulminant hepatic failure, defined as plasma/serum alanine aminotransferase (ALT) \>10,000 U/L or total bilirubin \>12.0 mg/dL, based on data available at or before patient meets criteria for study enrollment
• Known history of severe hepatic impairment, defined as cirrhosis, "liver failure", or awaiting transplant
• Known history of severe renal impairment, defined as peritoneal dialysis or hemodialysis
• Known metabolic/mitochondrial disorder, inborn error of metabolism, or primary mineralocorticoid deficiency as reported by participant, legally authorized representative (LAR) or accompanying caregiver, or as listed in the medical record
• Other concern for which the treating clinician deems it unsafe to administer either NS or LR
• Known pregnancy determined by routine history disclosed by patient and/or accompanying acquaintance.
• Known prisoner
• Known allergy to a crystalloid fluid
• Indication of declined consent to participate based on presence of an opt-out bracelet with appropriate messaging embossed into the bracelet, the presence of the patient's name on an opt-out list that will be kept up-to-date and checked prior to randomization, or verbal "opt-out" prior to enrollment.
DRUG: Lactated Ringer, DRUG: Normal Saline, DRUG: Plasma-lyte
Shock, Septic
Sepsis, Septic Shock, Fluid resuscitation, Saline, Balanced Fluid, Mortality, Crystalloid, PlasmaLyte, Lactated Ringer's, Kidney injury
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Show 24 locations
Study Locations
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| Location | Contacts |
|---|---|
| Boston Children's Hospital Boston, Massachusetts | Matt Eisenberg, MD - (Matthew.Eisenberg@childrens.harvard.edu) |
| CHLA: Children's Hospital Los Angeles Los Angeles, California | Ara Festekjian, MD - (afestekjian@chla.usc.edu) |
| CS Mott Children's Hospital Ann Arbor, Michigan | Alex Rogers, MD - (alexroge@umich.edu) Allison Cator, MD - (acator@med.umich.edu) |
| Children's Colorado: University of Colorado Denver, Colorado | Lilliam Ambroggio, PhD - (lilliam.ambroggio@cuanschutz.edu) |
| Children's Hospital of Atlanta Atlanta, Georgia | Claudia Morris, MD - (Claudia.r.morris@emory.edu) |
| Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania | Bob Hickey, MD - (robert.hickey@chp.edu) |
| Children's Hospital of Richmond at VCU Richmond, Virginia | Nikki Miller Ferguson, MD - (nikki.millerferguson@vcuhealth.org) |
| Children's National Medical Center Washington D.C., District of Columbia | Ioannis Koutroulis, MD - (IKOUTROULI@childrensnational.org) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Michelle Eckerle, MD - (Michelle.Eckerle@cchmc.org) |
| Columbia: New York-Presbyterian Hospital New York, New York | Maria Kwok, MD - (myk2102@cumc.columbia.edu) |
| Dallas Children's: Children's Medical Center Dallas/UT southwestern Dallas, Texas | Mohamed Badawy, MD - (Mohamed.Badawy@UTSouthwestern.edu) |
| Hasbro Children's Hospital Providence, Rhode Island | Susan Duffy, MD - (SDuffy@Lifespan.org) |
| Lurie Children's: Ann & Robert H. Lurie Children's Hospital of Chicago Chicago, Illinois | Elizabeth Alpern, MD - (EAlpern@luriechildrens.org) |
| Milwaukee (MCW): Medical College of Wisconsin Milwaukee, Wisconsin | Shannon Baumer-Mouradian, MD - (sbaumer@mcw.edu) |
| NYU Langone New York, New York | |
| Nationwide Children's Hospital Columbus, Ohio | Julia Lloyd, MD - (Julia.Lloyd@nationwidechildrens.org) |
| Primary Children's: University of Utah Salt Lake City, Utah | Roni Lane, MD - (roni.lane@hsc.utah.edu) |
| Seattle Children's Hospital Seattle, Washington | Neil Uspal, MD - (neil.uspal@seattlechildrens.org) |
| Texas Children's Hospital Houston, Texas | Julie McManemy, MD - (jkmcmane@texaschildrens.org) |
| The Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Fran Balamuth, MD PhD MSCE - (balamuthf@chop.edu) Scott Weiss, MD MSCE - (scott.weiss@nemours.org) |
| UC Davis: University of California, Davis Davis, California | Cheryl Vance, MD - (cpvance@ucdavis.edu) Nathan Kupperman, MD - (nkuppermann@ucdavis.edu) |
| UCSF Benioff Children's Hospital San Francisco, California | Karim Mansour, MD - (Karim.Mansour@ucsf.edu) |
| Universtity of Texas MD Anderson Houston, Texas | |
| Washington University St Louis, Missouri | Lindsay Clukies, MD - (lindsayedavidson@wustl.edu) |
Study of the Adverse Events and Change in Disease State of Pediatric Participants (and Young Adults Between the Ages of 18-25) With Relapsed/Refractory Aggressive Mature B-cell Neoplasms Receiving Subcutaneous (SC) Injections of Epcoritamab
ABBVIE CALL CENTER - abbvieclinicaltrials@abbvie.com
NCT05206357
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Inclusion Criteria:
• Participants >= 1 and < 18 years old at time of primary diagnosis with Burkitt's or Burkitt-like lymphoma/leukemia, diffuse large B-cell lymphoma (DLBCL), or other aggressive mature (CD20+) B-cell lymphomas. Participants up to 25 years of age with Burkitt's or Burkitt-like lymphoma/leukemia are also eligible.
• Disease pathologically confirmed (tumor tissue) by local testing.
• Relapsed or primary refractory disease meeting any of the following criteria:
• Progressive disease at any time during second-line chemoimmunotherapy (CIT).
• Best response of stable disease (SD) after a minimum of 2 cycles of second-line CIT.
• Best response of partial response (PR) after a minimum of 3 cycles of second-line CIT.
• Complete Response (CR) after a minimum of 3 cycles of second-line CIT therapy but unfit or ineligible for consolidation with cell therapy.
• Not in CR and unable to initiate or tolerate (i.e., must discontinue) second-line CIT.
• Have received cell therapy (allogeneic or autologous transplant or chimeric antigen receptor T-cell (CAR-T) therapy) as consolidation but have not obtained or maintained a CR.
• Recovery from toxic effects of prior chemoimmunotherapy.
• Performance status by Lansky (< 16 years old at evaluation) or Karnofsky (>= 16 years old at evaluation) score >= 50 or Eastern Cooperative Oncology Group (ECOG) score <= 2 .
• Adequate bone marrow, hepatic, and renal function.
Exclusion Criteria:
• Known central nervous system (CNS) involvement by lymphoma at screening as confirmed by screening magnetic resonance imaging (MRI)/computed tomography (CT)/positron emission tomography (PET) brain scans (participants with evidence of CNS disease only in the cerebrospinal fluid (CSF) will be eligible).
• Other malignancy requiring therapy.
• Currently receiving anti-cancer therapy, including chemotherapy (excluding intrathecal therapy), radiotherapy, small molecules, monoclonal antibodies, cell therapy, or other investigational agents.
Drug: Epcoritamab
Non-Hodgkin Lymphoma
Non-hodgkin Lymphoma, ABBV-GMAB-3013, Epcoritamab, Burkitt's or Burkitt-like Lymphoma/Leukemia, Diffuse Large B-cell Lymphoma, Aggressive Mature (CD20+) B-cell Lymphoma, Cancer, Relapsed/Refractory Aggressive Mature B-cell Neoplasms
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Show 44 locations
Study Locations
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| Location | Contacts |
|---|---|
| Azienda Ospedaliero Universitaria Meyer /ID# 240049 Florence, Firenze | |
| CHU Bordeaux - Hopital Pellegrin /ID# 240832 Bordeaux, | |
| CHU Sainte-Justine /ID# 240766 Montreal, Quebec | |
| CHU de Nantes, Hotel Dieu -HME /ID# 240831 Nantes, Pays-de-la-Loire | |
| Children's Hospital at Westmead /ID# 240091 Westmead, | |
| Children's Hospital of Philadelphia - Main /ID# 239294 Philadelphia, Pennsylvania | |
| Children's Hospital of Richmond at VCU /ID# 242770 Richmond, Virginia | |
| Cincinnati Childrens Hospital Medical Center /ID# 239823 Cincinnati, Ohio | |
| Dokuz Eylul University Medical Faculty /ID# 239954 Izmir, | |
| Fakultni Nemocnice Brno /ID# 239956 Brno, | |
| Fakultni Nemocnice v Motole /ID# 239957 Praha, | |
| Fondazione IRCCS San Gerardo dei Tintori /ID# 245592 Monza, Monza E Brianza | |
| Hospices Civils de Lyon /ID# 240834 Lyon, | |
| Hospital Infantil Universitario Nino Jesus /ID# 240717 Madrid, | |
| Hospital Universitario Vall d'Hebron /ID# 240715 Barcelona, | |
| Hospital for Sick Children /ID# 240767 Toronto, Ontario | |
| IRCCS Ospedale Pediatrico Bambino Gesu /ID# 240039 Rome, Lazio | |
| Institut Gustave Roussy /ID# 240966 Villejuif Cedex, Val-de-Marne | |
| Koc Universitesi Hastanesi Translasyonel Tip Arastirma Merkezi /ID# 240026 Istanbul, | |
| Kyoto University Hospital /ID# 246907 Kyoto-shi, Kyoto | |
| Levine Children's Hospital /ID# 242765 Charlotte, North Carolina | |
| Lucile Packard Children's Hospitals - Stanford /ID# 240854 Palo Alto, California | |
| NHO Nagoya Medical Center /ID# 246680 Nagoya-shi, Aichi | |
| National Cancer Center Hospital /ID# 246722 Chuo-ku, Tokyo | |
| National Center for Child Health and Development /ID# 246658 Setagaya-ku, Tokyo | |
| National Taiwan University Hospital /ID# 242890 Taipei City, | |
| New York Medical College /ID# 239208 Valhalla, New York | |
| Nicklaus Children's Hospital /ID# 241174 Miami, Florida | |
| Osaka City General Hospital /ID# 246906 Osaka-shi, Osaka | |
| Perth Children's Hospital /ID# 240382 Nedlands, Western Australia | |
| Prinses Maxima Centrum /ID# 239815 Utrecht, | |
| Rambam Health Care Campus /ID# 240037 Haifa, | |
| Royal Children's Hospital /ID# 240384 Parkville, Victoria | |
| Samsung Medical Center /ID# 239895 Seoul, | |
| Schneider Children's Medical Center /ID# 240171 Petah Tikva, | |
| Seoul National University Hospital /ID# 239894 Seoul, | |
| St Jude Children's Research Hospital /ID# 239184 Memphis, Tennessee | |
| The Chaim Sheba Medical Center /ID# 240670 Ramat Gan, Tel-Aviv | |
| Universitaetsklinikum Erlangen /ID# 240861 Erlangen, Bayern | |
| Universitaetsklinikum Giessen und Marburg /ID# 240787 Marburg, | |
| Universitaetsklinikum Muenster /ID# 239970 Muenster, Nordrhein-Westfalen | |
| Universitaetsmedizin Rostock /ID# 240891 Rostock, | |
| Universitair Ziekenhuis Leuven /ID# 242384 Leuven, Vlaams-Brabant | |
| University of Texas Southwestern Medical Center /ID# 240892 Dallas, Texas |
A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1) (cAMeLot-1)
Study Contact - Participate-In-This-Study1@its.jnj.com
NCT04811560
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Inclusion Criteria:
Phase 1:
* Age 2 years and above (pediatric cohort only), all other cohorts 18 years and above
* Relapsed or refractory (R/R) acute leukemia and has exhausted, or is ineligible for, available therapeutic options
* Acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A), nucleophosmin 1 gene (NPM1) or nucleoporin 98 gene or nucleoporin 214 gene (NUP98 or NUP214) alterations
Phase: 2
* Participants greater than 18 years are eligible
* Must have had an initial diagnosis of acute myeloid leukemia (AML) per the WHO 2022 classification criteria and have relapsed/refractory disease
* AML harboring KMT2A-r (gene rearrangement/translocation) or NPM1 mutations only
For Both Phase 1 and 2:
* Pretreatment clinical laboratory values meeting the following criteria: (a) Hematology: white blood cell (WBC) count less than or equal to (\<=) 20\*10\^9/liter (L) and (b) renal function; For adult participants, estimated or measured glomerular filtration rate greater than equal (\>=) 30 milliliter per minute (mL/min) per four variable MDRD equation. For pediatric participants an estimated or measured glomerular filtration rate \>50 mL/min per the CKiD (Chronic Kidney Disease in Children) Schwartz formula
* Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2. Pediatric participants only: Performance status \>=70 by Lansky scale (for participants less than \[\<\]16 years of age) or \>=70 Karnofsky scale (for participants \>=16 years of age)
* A female of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin at screening and within 48 hours prior to the first dose of study treatment
* Participant must agree to all protocol required contraception requirements and avoid sperm or egg donations or freezing for future reproductive use while on study and for 90 days (males) or 6 months (females) after the last dose of study treatment
Exclusion Criteria:
* Acute promyelocytic leukemia, diagnosis of Down syndrome associated leukemia or juvenile myelomonocytic leukemia according to World Health Organization (WHO) 2016 criteria
* Active central nervous system (CNS) disease
* Prior solid organ transplantation
* QTc according to Fridericia's formula (QTcF) for males \>= 450 millisecond (msec) or for females \>= 470 msec. Participants with a family history of Long QT syndrome are excluded
* Exclusion criteria related to stem cell transplant: a. Received prior treatment with allogenic bone marrow or stem cell transplant \<=3 months before the first dose of study treatment; b. Has evidence of graft versus host disease; c. Received donor lymphocyte infusion \<=1 month before the first dose of study treatment; d. Requires immunosuppressant therapy (exception: daily doses \<=10 milligrams (mg) prednisone or equivalent are allowed for adrenal replacement)
* Prior cancer immunotherapy within 4 weeks prior to enrollment or blinatumomab within 2 weeks prior to enrollment. Additional prior cancer therapies must not be given within 4 weeks prior to enrollment or 5 half-lives of the agent (whichever is shorter) DRUG: Bleximenib
Acute Leukemias, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
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Show 99 locations
Study Locations
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| Location | Contacts |
|---|---|
| Asan Medical Center Seoul, | |
| Baylor University Medical Center Dallas, Texas | |
| CHRU Nancy Brabois Vandœuvre-lès-Nancy, | |
| CHU Bretonneau Tours, | |
| CHU Lyon Sud Pierre-Bénite, | |
| CHU de Nantes hotel Dieu Nantes, | |
| Carmel Medical Center Haifa, Haifa District | |
| Centre Hospitalier Universitaire (CHU) de Bordeaux Hopital HautLeveque Centre Francois Magendie Pessac, | |
| China Medical University Hospital Taichung, | |
| City of Hope Duarte, California | |
| Clinica Univ. de Navarra Pamplona, | |
| Dana Farber Cancer Institute Boston, Massachusetts | |
| First Affiliated Hospital Medical School of Zhejiang University Hangzhou, | |
| Fox Chase Cancer Center Philadelphia, Pennsylvania | |
| Fukushima Medical University Hospital Fukushima, | |
| Fundacao Antonio Prudente A C Camargo Cancer Center São Paulo, | |
| Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo São Paulo, | |
| Gold Coast University Hospital Southport, | |
| Gunmaken Saiseikai Maebashi Hospital Maebashi, | |
| Gustave Roussy Villejuif, Val-de-Marne | |
| Guys and St Thomas NHS Foundation Trust London, | |
| Hadassah University Hospita Ein Kerem Jerusalem, | |
| Henan Cancer Hospital Zhengzhou, | |
| Hokkaido University Hospital Sapporo, Hokkaido | |
| Hopital Jean Minjoz Besançon, | |
| Hopital Maisonneuve Rosemont Montreal, Quebec | |
| Hopital Saint Louis Paris, | |
| Hopital trousseau- APHP Paris, | |
| Hosp Clinic de Barcelona Barcelona, | |
| Hosp Clinico Univ de Salamanca Salamanca, | |
| Hosp Univ Fund Jimenez Diaz Madrid, | |
| Hosp Univ Vall D Hebron Barcelona, | |
| Hosp. Clinico Univ. de Valencia Valencia, | |
| Hosp. Gral. Univ. Gregorio Marañon Madrid, | |
| Hosp. Virgen Del Rocio Seville, | |
| Houston Methodist Hospital Houston, Texas | |
| Institut Paoli Calmettes Marseille, | |
| Institut Universitaire du Cancer Toulouse Oncopole Toulouse, | |
| Institut de Cancerologie Strasbourg Europe ICANS Strasbourg, | |
| Institute of Hematology and Blood Diseases Hospital Tianjin, | |
| Instituto D Or de Pesquisa e Ensino Brasília, | |
| Instituto D Or de Pesquisa e Ensino IDOR São Paulo, | |
| Kanazawa University Hospital Kanazawa, | |
| Karmanos Cancer Institute Detroit, Michigan | |
| Kobe City Medical Center General Hospital Kobe, | |
| Kyushu University Hospital Fukuoka, | |
| Leeds Teaching Hospitals NHS Trust Leeds, | |
| Liga Norte Riograndense Contra O Cancer Natal, Rio Grande do Norte | |
| MD Anderson Houston, Texas | |
| Maine Health Providence, Rhode Island | |
| Massachusetts General Hospital Boston, Massachusetts | |
| Medical College of WI at Froedtert Milwaukee, Wisconsin | |
| Ministerio da Saude Instituto Nacional do Cancer Rio de Janeiro, | |
| Monash Medical Centre Clayton, | |
| Montefiore Medical Center The Bronx, New York | |
| NTT Medical Center Tokyo Tokyo, | |
| NYU Langone Medical Center New York, New York | |
| Nagoya University Hospital Nagoya, | |
| Nanfang Hospital of Southern Medical Hospital Guangzhou, | |
| National Cancer Center Hospital East Kashiwa, Chiba | |
| National Cheng Kung University Hospital Tainan City, TNN | |
| National Taiwan University Hospital Taipei, | |
| Norton Cancer Institute Louisville, Kentucky | |
| Oregon Health and Science University Portland, Oregon | |
| Oxford University Hospitals NHS Trust Oxfordshire, | |
| Peking University First Hospital Beijing, | |
| Princess Margaret Cancer Centre University Health Network Toronto, Ontario | |
| Qilu Hospital of Shandong University Jinan, | |
| Roswell Park Comprehensive Cancer Center Buffalo, New York | |
| Royal Perth Hospital Perth, | |
| START Midwest Grand Rapids, Michigan | |
| Samsung Medical Center Seoul, | |
| San Antonio Methodist TX Transplant Physicians Group San Antonio, Texas | |
| Seoul National University Hospital Seoul, Seoul Teugbyeolsi | |
| Sheba Medical Center Ramat Gan, | |
| St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation Indianapolis, Indiana | |
| Swedish Cancer Institute Seattle, Washington | |
| Tel Aviv Sourasky Medical Center Tel Aviv, | |
| The Christie NHS Foundation Trust Manchester, | |
| The Clatterbridge Cancer Centre Liverpool, | |
| The First Affiliated Hospital of NanChang University Nanchang, | |
| The First Affiliated Hospital of Wenzhou Medical University Wenzhou, | |
| Union Hospital Tongji Medical College of Huazhong University of Science and Technology Wuhan, | |
| University College London Hospitals London, | |
| University Hospital of Wales Cardiff, | |
| University Hospitals Plymouth NHS Trust Plymouth, | |
| University of California Irvine Medical Center Orange, California | |
| University of California San Francisco San Francisco, California | |
| University of California San Francisco San Francisco, California | |
| University of Chicago Chicago, Illinois | |
| University of Fukui Hospital Yoshida, | |
| University of New Mexico Albuquerque, New Mexico | |
| University of Tennessee Medical Center Knoxville, Tennessee | |
| Vancouver Coastal Health Vancouver, British Columbia | |
| Virginia Commonwealth University Richmond, Virginia | |
| West China Hospital Si Chuan University Chengdu, | |
| Yamagata University Hospital Yamagata, | |
| Zhongda Hospital Southeast University Nanjing, | |
| the First Hospital of Jilin University Changchun, |
Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003) (OMAHA-003)
Toll Free Number - Trialsites@msd.com
NCT06136624
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Inclusion Criteria:
* Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology.
* Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months before Screening
* Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI).
* Has disease that progressed during or after treatment with 1 novel hormonal agent (NHA)
* Has received 1 but no more than 2 taxane-based chemotherapy regimens for metastatic castration-resistant prostate cancer (mCRPC) and has had progressive disease (PD) during or after treatment
* Has ongoing androgen deprivation with serum testosterone \<50 ng/dL (\<1.7 nM)
* Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization
* Has had prior treatment with PARPi or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment
* Has received prior 177Lu-PSMA-617 or were deemed ineligible to receive 177Lu-PSMA-617 treatment by the investigator or refused 177Lu-PSMA-617 treatment
* Participants who have not received cabazitaxel can be enrolled if they are ineligible for cabazitaxel treatment as determined by the investigator or have refused treatment
* If participant received first generation anti-androgen therapy before screening, the participant has evidence of disease progression \>4 weeks since the last flutamide treatment and \>6 weeks since the last bicalutamide or nilutamide treatment
* Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses for ≥ 4 weeks before the date of randomization
* Participants with human immunodeficiency virus (HIV) infection must have well controlled HIV on antiretroviral therapy (ART)
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at Screening.
* Participants who can produce sperm must agree to the following during the study treatment period and for at least 7 days after the last dose of opevesostat, for at least 30 days after the last dose of abiraterone acetate, and for at least 3 months after the last dose of enzalutamide: EITHER be abstinent OR must agree to use male condom
Exclusion Criteria:
* Has a gastrointestinal disorder that might affect absorption
* Has a history of pituitary dysfunction
* Has poorly controlled diabetes mellitus
* Has clinically significant abnormal serum potassium or sodium level
* Has a history of active or unstable cardio/cerebro-vascular disease, including thromboembolic events
* Has a history of seizure within 6 months of providing documented informed consent or any condition that may predispose to seizures within 12 months before the date of randomization
* Has a history of clinically significant ventricular arrhythmias
* Has received an anticancer monoclonal antibody (mAb) within 4 weeks before the date of randomization, or has not recovered from adverse events (AEs) due to mAbs administered more than 4 weeks before the date of randomization
* Has undergone major surgery, including local prostate intervention (except prostate biopsy), within 28 days before the date of randomization, and has not recovered from the toxicities and/or complications
* Participants who have not adequately recovered from major surgery or have ongoing surgical complications
* Has used herbal or medicinal products that may have hormonal anti-prostate cancer activity and/or are known to decrease prostate-specific Antigen (PSA) (eg, saw palmetto, megesterol acetate, citrus pectin polysaccharide) within 4 weeks before the date of randomization
* Has received radium-223 or lutetium-177 within 4 weeks before the date of randomization, or has not recovered to Grade ≤1 or baseline from AEs due to radium-223 or lutetium-177 administered more than 4 weeks before the date of randomization
* Has received treatment with 5-αreductase inhibitors (eg, finasteride or dutasteride), estrogens, or cyproterone within 4 weeks before the date of randomization
* Has received colony-stimulating factors within 28 days before the date of randomization
* Has received a whole blood transfusion in the last 120 days before the date of randomization. Packed red blood cells and platelet transfusions are acceptable if not given within 28 days of the date of randomization
* Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention as follows: enzalutamide or apalutamide within 3 weeks or abiraterone acetate + prednisone or darolutamide within 2 weeks
* Has a "superscan" bone scan
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has an active infection requiring systemic therapy
* Has concurrent active HBV or known active HCV infection
* Has a history of long QTc syndrome
* Has any of the following at Screening Visit: hypotension (systolic BP \<110 mm Hg) or uncontrolled hypertension (systolic BP ≥160 mm Hg or diastolic BP ≥90 mm Hg, in 2 out of 3 recordings with optimized antihypertensive therapy)
* Is unable to swallow capsules/tablets
* Is currently being treated with cytochrome 450-inducing antiepileptic drugs for seizures
* Participants on an unstable dose of thyroid hormone therapy within 6 months before the start of the study intervention
* Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
* Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
* Systemic use of the following medications within 2 weeks before the first dose of study intervention: strong CYP3A4 inducers (eg, avasimibe, carbamazepine, lumacaftor, phenobarbital, rifampicin, rifapentine, or St John's Wort); P-gp inhibitors (eg, erythromycin, clarithromycin, rifampicin, ketoconazole, itraconazole, posaconazole, artesunate-pyronaridine, ritonavir, indinavir, nelfinavir, atazanavir, glecaprevir-pibrentasvir, simeprevir, ledipasvir-sofosbuvir, verapamil, diltiazem, dronedarone, propafenone, quinidine, cyclosporine, valspodar, or milk thistle \[Silybum marianum\])
* Use of aldosterone antagonist (eg, spironolactone, eplerenone) and phenytoin within 4 weeks before the start of the study intervention DRUG: Opevesostat, DRUG: Abiraterone acetate, DRUG: Enzalutamide, DRUG: Hydrocortisone, DRUG: Fludrocortisone acetate, DRUG: Prednisone, DRUG: Dexamethasone
Prostate Cancer Metastatic
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Show 279 locations
Study Locations
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| Location | Contacts |
|---|---|
| A. C. Camargo Cancer Center ( Site 0310) São Paulo, São Paulo | |
| AHN Allegheny General Hospital ( Site 0001) Pittsburgh, Pennsylvania | |
| Ad-Vance Medical Research-Research ( Site 1353) Ponce, | |
| Addenbrooke's Hospital ( Site 1605) Cambridge, Cambridgeshire | |
| Affiliated hospital of Jiangnan university ( Site 0434) Wuxi, Jiangsu | |
| Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1477) Uppsala, Uppsala County | |
| Akershus Universitetssykehus-Onkologisk avdeling ( Site 1227) Lørenskog, Akershus | |
| Akita University Hospital ( Site 0904) Akita, | |
| Aliada-Oncologìa ( Site 1257) Lima, | |
| Amsterdam UMC, locatie VUmc ( Site 1156) Amsterdam, North Holland | |
| Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1552) Ankara, | |
| Anschutz Cancer Pavilion ( Site 0046) Aurora, Colorado | |
| Asahikawa Medical University Hospital ( Site 0901) Asahikawa, Hokkaido | |
| Asan Medical Center-Oncology ( Site 1402) Songpagu, Seoul | |
| Asociación de Beneficencia Hospital Sirio Libanés ( Site 0205) Buenos Aires, Buenos Aires F.D. | |
| Atlantic Health System Morristown Medical Center ( Site 0115) Morristown, New Jersey | |
| Avera Cancer Institute - Pierre ( Site 0118) Pierre, South Dakota | |
| Avera Cancer Institute - Yankton ( Site 0117) Yankton, South Dakota | |
| Avera Cancer Institute- Research ( Site 0094) Sioux Falls, South Dakota | |
| Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 0752) Kecskemét, Bács-Kiskun county | |
| Baltimore Veterans Affairs Medical Center ( Site 0069) Baltimore, Maryland | |
| Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1554) Adana, | |
| Beijing Cancer hospital-Urinary Surgery ( Site 0395) Beijing, Beijing Municipality | |
| Beijing Friendship Hospital Affiliate of Capital University ( Site 0396) Beijing, Beijing Municipality | |
| Bell Land General Hospital ( Site 0913) Sakai, Osaka | |
| Blue Ridge Cancer Care ( Site 0004) Roanoke, Virginia | |
| Bradford Hill Norte ( Site 0357) Antofagasta, | |
| Bradfordhill-Clinical Area ( Site 0351) Santiago, Region M. de Santiago | |
| Bruce W. Carter Veterans Affairs Medical Center ( Site 0082) Miami, Florida | |
| CIO - Centro de Inmuno-Oncología de Occidente ( Site 1103) Guadalajara, Jalisco | |
| Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 0632) Rennes, Ille-et-Vilaine | |
| Centre Hospitalier Universitaire de Nîmes - Institut de Cancérologie du Gard - Hôpital Universitaire ( Site 0630) Nîmes, Gard | |
| Centre Hospitalier de l'Université de Montréal ( Site 0326) Montreal, Quebec | |
| Centre Hospitalier de la Côte Basque ( Site 0633) Bayonne, Pyrenees-Atlantiques | |
| Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0328) Greenfield Park, Quebec | |
| Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 0629) Clermont-Ferrand, Puy-de-Dome | |
| Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0327) Québec, Quebec | |
| Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0329) Sherbrooke, Quebec | |
| Centro de Investigacion Clinica de Oaxaca ( Site 1109) Oaxaca City, | |
| Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1302) Bydgoszcz, Kuyavian-Pomeranian Voivodeship | |
| Chang Gung Medical Foundation-Linkou Branch-Medical Oncology ( Site 1504) Taoyuan District, | |
| Charing Cross Hospital-Oncology Research ( Site 1606) London, Hammersmith and Fulham | |
| Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0679) Berlin, | |
| China Medical University Hospital-Department of Urology ( Site 1503) Taichung, | |
| Chongqing Three Gorges Central Hospital's ( Site 0426) Chongqing, Chongqing Municipality | |
| Chongqing University Cancer Hospital ( Site 0416) Chongqing, Chongqing Municipality | |
| Chulalongkorn University ( Site 1530) Bangkok, Bangkok | |
| Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0501) Bogotá, Bogota D.C. | |
| Clinica Universidad Catolica del Maule-Oncology ( Site 0355) Talca, Maule Region | |
| Clinical Research Chile SpA ( Site 0358) Valdivia, Los Ríos Region | |
| Clínica Imbanaco S.A.S ( Site 0509) Santiago de Cali, Valle del Cauca Department | |
| Clínica Sánchez Ferrer ( Site 1261) Trujillo, La Libertad | |
| Clínica de Neoplasias Litoral ( Site 0305) Itajaí, Santa Catarina | |
| Colorado Clinical Research ( Site 0067) Lakewood, Colorado | |
| Complexo Hospitalario Universitario de Ourense ( Site 1426) Ourense, Orense | |
| Comprehensive Cancer Centers of Nevada ( Site 0010) Las Vegas, Nevada | |
| Cross Cancer Institute ( Site 0332) Edmonton, Alberta | |
| Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 0758) Debrecen, | |
| Dubbo Hospital ( Site 0235) Dubbo, New South Wales | |
| Dunedin Hospital-Southern Blood and Cancers Service ( Site 1203) Dunedin, Otago | |
| ETZ Elisabeth-Internal Medicine ( Site 1160) Tilburg, North Brabant | |
| Ehime University Hospital ( Site 0918) Tōon, Ehime | |
| Emek Medical Center ( Site 0830) Afula, | |
| FALP ( Site 0353) Santiago, Region M. de Santiago | |
| Faculty of Medicine - Khon Kaen University ( Site 1526) Muang, Changwat Khon Kaen | |
| Faculty of Medicine Siriraj Hospital ( Site 1531) Bangkok, Bangkok | |
| Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0555) Olomouc, Olomoucký kraj | |
| Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 0554) Ostrava, Moravskoslezský kraj | |
| Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0551) Prague, Praha 5 | |
| Filios Alta Medicina ( Site 1106) Monterrey, Nuevo León | |
| First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 0436) Huaian, Jiangsu | |
| Florida Cancer Specialists - South ( Site 7003) Fort Myers, Florida | |
| Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0877) Milan, Lombardy | |
| Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 1151) Schiedam, South Holland | |
| Fred Hutchinson Cancer Center ( Site 0013) Seattle, Washington | |
| Fudan University Shanghai Cancer Center-Urology department ( Site 0376) Shanghai, Shanghai Municipality | |
| Fukushima Medical University Hospital ( Site 0933) Fukushima, | |
| Fundacion Centro Oncologico de Integración Regional-Medical Oncology ( Site 0204) Mendoza, | |
| Fundación Cardiovascular de Colombia ( Site 0503) Piedecuesta, Santander Department | |
| Fundación Instituto Valenciano de Oncología-Oncologico ( Site 1430) Valencia, Valenciana, Comunitat | |
| Fundación Valle del Lili ( Site 0505) Santiago de Cali, Valle del Cauca Department | |
| Gifu University Hospital ( Site 0910) Gifu, | |
| Greenebaum Comprehensive Cancer Center ( Site 0049) Baltimore, Maryland | |
| Gulhane Egitim Arastirma Hastanesi ( Site 1558) Ankara, | |
| Gustave Roussy ( Site 0626) Villejuif, Val-de-Marne | |
| HELIOS Kliniken Schwerin ( Site 0694) Schwerin, Mecklenburg-Vorpommern | |
| HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 1428) Seville, | |
| Hacettepe Universite Hastaneleri-oncology hospital ( Site 1551) Ankara, | |
| Hadassah Medical Center ( Site 0833) Jerusalem, | |
| Haga Ziekenhuis locatie Leyweg-Oncology ( Site 1164) The Hague, South Holland | |
| Henry Ford Hospital ( Site 0015) Detroit, Michigan | |
| Hiroshima University Hospital ( Site 0916) Hiroshima, | |
| Hokkaido University Hospital ( Site 0931) Sapporo, Hokkaido | |
| Hospital Aleman-Oncology ( Site 0207) Buenos Aires, | |
| Hospital Británico de Buenos Aires-Oncology ( Site 0202) Ciudad Autónoma de Buenos Aires, Buenos Aires | |
| Hospital Felicio Rocho ( Site 0317) Belo Horizonte, Minas Gerais | |
| Hospital Jerez de la Frontera ( Site 1427) Jerez de la Frontera, Cadiz | |
| Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 1078) Kuala Lumpur, | |
| Hospital Lucus Augusti-Oncology ( Site 1432) Lugo, | |
| Hospital Mario Penna ( Site 0309) Belo Horizonte, Minas Gerais | |
| Hospital Santa Rita de Cassia-Centro de Pesquisa Clínica ( Site 0320) Vitória, Espírito Santo | |
| Hospital Sultan Ismail ( Site 1081) Johor Bahru, Johor | |
| Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1433) Madrid, Madrid, Comunidad de | |
| Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1431) Madrid, Madrid, Comunidad de | |
| Hospital Universitário Evangélico Mackenzie-Centro de Oncologia Mackenzie ( Site 0314) Curitiba, Paraná | |
| Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0308) Bragança Paulista, São Paulo | |
| Hospital of the University of Occupational and Environmental Health, Japan ( Site 0921) Kitakyushu, Fukuoka | |
| Huadong Hospital Affiliated to Fudan University-Urology ( Site 0388) Shanghai, Shanghai Municipality | |
| Hubei Cancer Hospital-Urinary surgery ( Site 0406) Wuhan, Hubei | |
| Hunan Cancer Hospital ( Site 0405) Changsha, Hunan | |
| Hôpital Européen Georges Pompidou ( Site 0628) Paris, | |
| IC La Serena Research ( Site 0356) La Serena, Coquimbo Region | |
| IMAT S.A.S ( Site 0504) Montería, Departamento de Córdoba | |
| INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS-Medical Oncology ( Site 1256) Lima, | |
| IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 1254) Lima, | |
| IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 0879) Meldola, Emilia-Romagna | |
| Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0627) Strasbourg, Alsace | |
| Instituto Alexander Fleming-Alexander Fleming ( Site 0206) Buenos Aires, Buenos Aires F.D. | |
| Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 1258) Concepción, Departamento de Junín | |
| Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201) Mar del Plata, Buenos Aires | |
| Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1555) Istanbul, | |
| James J. Peters VA Medical Center ( Site 0088) The Bronx, New York | |
| Jiangxi Cancer Hospital ( Site 0386) Nanchang, Jiangxi | |
| Kagawa University Hospital ( Site 0917) Kita, Kagawa-ken | |
| Kagoshima University Hospital ( Site 0929) Kagoshima, | |
| Kaiser Permanente Riverside Medical Center ( Site 0099) Riverside, California | |
| Kanazawa Medical University Hospital ( Site 0909) Mukai-awagasaki, Ishikawa-ken | |
| Kansai Medical University Hospital ( Site 0912) Hirakata, Osaka | |
| Karolinska Universitetssjukhuset Solna ( Site 1478) Stockholm, Stockholm County | |
| Klinikum Wels-Grieskirchen GmbH ( Site 0279) Wels, Upper Austria | |
| Kobe University Hospital ( Site 0914) Kobe, Hyōgo | |
| Kuopion Yliopistollinen Sairaala ( Site 0603) Kuopio, Northern Savonia | |
| Kurume University Hospital ( Site 0920) Kurume, Fukuoka | |
| Kyushu University Hospital ( Site 0919) Fukuoka, | |
| M Health Fairview Clinics and Surgery Center ( Site 0019) Minneapolis, Minnesota | |
| MEDICAL COLLEGE OF WISCONSIN ( Site 0020) Milwaukee, Wisconsin | |
| Macquarie University-MQ Health Clinical Trials Unit ( Site 0234) Macquarie University, New South Wales | |
| Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0553) Brno, Brno-mesto | |
| Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1310) Siedlce, Masovian Voivodeship | |
| Meander Medisch Centrum ( Site 1157) Amersfoort, Utrecht | |
| Medical Care and Research SA de CV ( Site 1108) Mérida, Yucatán | |
| Medische Centrum Leeuwarden ( Site 1172) Leeuwarden, Provincie Friesland | |
| Medizinische Universität Graz-Innere Medizin Klin. Abt. Onkologie ( Site 0280) Graz, Styria | |
| Meir Medical Center. ( Site 0832) Kfar Saba, | |
| Memorial Ankara Hastanesi-Medical Oncology ( Site 1557) Ankara, | |
| Metro-Minnesota Community Clinical Oncology ( Site 0014) Saint Louis Park, Minnesota | |
| Miyazaki Prefectural Miyazaki Hospital ( Site 0927) Miyazaki, | |
| Nagano Municipal Hospital ( Site 0932) Nagano, | |
| Nanbu Tokushukai Hospital ( Site 0930) Shimajiri, Okinawa | |
| Nanchong Central Hospital-urology ( Site 0422) Nanchong, Sichuan | |
| Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( Site 0377) Nanjing, Jiangsu | |
| Nara Medical University Hospital ( Site 0915) Kashihara, Nara | |
| National Cancer Centre Singapore ( Site 1377) Singapore, Central Singapore | |
| National Cancer Institute ( Site 1079) Putrajaya, Putrajaya | |
| National Cheng Kung University Hospital-Urology ( Site 1502) Tainan City, | |
| National Hospital Organization Kumamoto Medical Center ( Site 0924) Kumamoto, | |
| National Hospital Organization Nagasaki Medical Center ( Site 0923) Ōmura, Nagasaki | |
| National Hospital Organization Oita Medical Center ( Site 0925) Ōita, | |
| National Taiwan University Hospital-Urology ( Site 1506) Taipei, | |
| National University Hospital ( Site 1376) Singapore, Central Singapore | |
| Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 1153) Amsterdam, North Holland | |
| Nograd Varmegyei Szent Lazar Korhaz-Onkologia es Sugarterapias Osztaly ( Site 0761) Salgótarján, Nógrád megye | |
| Obras Sociais Irma Dulce ( Site 0302) Salvador, Estado de Bahia | |
| Ochsner Clinic Foundation ( Site 0108) New Orleans, Louisiana | |
| Odense Universitetshospital-Department of oncology ( Site 0579) Odense, Region Syddanmark | |
| Oncosalud-Clinical Research ( Site 1260) Lima, | |
| Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 0276) Linz, Upper Austria | |
| Oregon Health and Science University ( Site 0028) Portland, Oregon | |
| Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 0756) Budapest, Pest County | |
| Ospedale San Raffaele-Oncologia Medica ( Site 0876) Milan, | |
| Pan American Center for Oncology Trials - Ciudadela ( Site 1351) San Juan, | |
| Peking University First Hospital-Urology ( Site 0390) Beijing, Beijing Municipality | |
| Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0230) Melbourne, Victoria | |
| Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0354) Santiago, Region M. de Santiago | |
| Prince of Wales Hospital ( Site 0730) Shatin, | |
| Princess Alexandra Hospital-Cancer Care Serices ( Site 0237) Brisbane, Queensland | |
| Princess Margaret Cancer Centre ( Site 0330) Toronto, Ontario | |
| Puerto Rico Medical Research Center LLC ( Site 1354) Hato Rey, | |
| Queen Mary Hospital ( Site 0727) Hong Kong, | |
| Quemex Medical and Research ( Site 1112) Mexico City, Mexico City | |
| Rabin Medical Center ( Site 0828) Petah Tikva, | |
| Radboudumc-Medical Oncology ( Site 1152) Nijmegen, Gelderland | |
| Ralph H. Johnson VA Health Care System (RHJVAHCS)-Urology ( Site 0083) Charleston, South Carolina | |
| Rambam Health Care Campus-Oncology Division ( Site 0826) Haifa, | |
| Regionalny Szpital Specjalistyczny im. dr. Władyslawa Biegańskiego ( Site 1316) Grudziądz, Kuyavian-Pomeranian Voivodeship | |
| Rigshospitalet ( Site 0576) Copenhagen, Capital Region | |
| Rutgers Cancer Institute of New Jersey ( Site 0033) New Brunswick, New Jersey | |
| SCRI Oncology Partners ( Site 7000) Nashville, Tennessee | |
| Saga-Ken Medical Centre Koseikan ( Site 0922) Saga, Saga-ken | |
| Sahlgrenska Universitetssjukhuset ( Site 1479) Gothenburg, Västra Götaland County | |
| Samsung Medical Center ( Site 1405) Seoul, | |
| Sanatorio Parque ( Site 0208) Rosario, Santa Fe Province | |
| Sapporo Medical University Hospital ( Site 0902) Sapporo, Hokkaido | |
| Sarawak General Hospital-Radiotherapy Unit ( Site 1076) Kuching, Sarawak | |
| Second Affiliated hospital of Anhui Medical University-Urology ( Site 0408) Hefei, Anhui | |
| Seoul National University Hospital-Oncology ( Site 1401) Seoul, | |
| Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1404) Seoul, | |
| Sheba Medical Center ( Site 0827) Ramat Gan, | |
| Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0502) Valledupar, Cesar Department | |
| Songklanagarind hospital ( Site 1527) Hat Yai, Changwat Songkhla | |
| Southwest Hospital of Third Military Medical University ( Site 0420) Chongqing, Chongqing Municipality | |
| Spaarne Gasthuis - Hoofddorp-Oncology ( Site 1170) Hoofddorp, North Holland | |
| St. Olavs Hospital-Kreftklinikken ( Site 1231) Trondheim, Sor-Trondelag | |
| St. Vincent's University Hospital ( Site 0802) Dublin, Dublin | |
| Stanford Cancer Center ( Site 0036) Palo Alto, California | |
| Suining Central Hospital ( Site 0437) Suining, Sichuan | |
| Sun Yat-sen University Cancer Center-Internal medicine ( Site 0413) Guangzhou, Guangdong | |
| Sunnybrook Research Institute ( Site 0331) Toronto, Ontario | |
| Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch ( Site 1318) Kielce, Świętokrzyskie Voivodeship | |
| Sykehuset Østfold Kalnes ( Site 1228) Sarpsborg, Østfold fylke | |
| Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1303) Koszalin, West Pomeranian Voivodeship | |
| TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1553) Istanbul, | |
| Taipei Veterans General Hospital ( Site 1505) Taipei, | |
| Tallaght University Hospital ( Site 0801) Dublin, | |
| Tampereen yliopistollinen sairaala ( Site 0604) Tampere, Pirkanmaa | |
| Tan Tock Seng Hospital-Medical Oncology ( Site 1378) Singapore, Central Singapore | |
| Tauranga Hospital-Bay of Plenty Clinical Trials Unit ( Site 1201) Tauranga, Bay of Plenty | |
| Texas Oncology - Central/South Texas ( Site 8003) Austin, Texas | |
| Texas Oncology - DFW ( Site 8001) Dallas, Texas | |
| Texas Oncology - Gulf Coast ( Site 8002) The Woodlands, Texas | |
| The Beatson West of Scotland Cancer Centre ( Site 1603) Glasgow, Glasgow City | |
| The Christie NHS Foundation Trust ( Site 1608) Manchester, | |
| The First Affiliated Hospital Of Fujian Medical University-Urology ( Site 0414) Fuzhou, Fujian | |
| The First Affiliated Hospital of Chongqing Medical University ( Site 0427) Chongqing, Chongqing Municipality | |
| The First Affiliated Hospital of Guangzhou Medical University ( Site 0412) Guangzhou, Guangdong | |
| The First Affiliated Hospital of Ningbo University ( Site 0383) Ningbo, Zhejiang | |
| The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 0379) Wenzhou, Zhejiang | |
| The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 0393) Xi'an, Shaanxi | |
| The First Affiliated hospital of Xiamen University-Urology ( Site 0415) Xiamen, Fujian | |
| The First Hospital of Jiaxing-urology ( Site 0380) Jiaxing, Zhejiang | |
| The Jikei University Hospital ( Site 0907) Minato, Tokyo | |
| The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 0336) Ottawa, Ontario | |
| The Royal Cornwall Hospital ( Site 1610) Truro, England | |
| The Second Affiliated Hospital Of Kunming Medical University ( Site 0429) Kunming, Yunnan | |
| The Second Affiliated Hospital of Xi'an Jiaotong University ( Site 0394) Xi'an, Shaanxi | |
| The Second Hospital of Tianjin Medical University ( Site 0391) Tianjin, Tianjin Municipality | |
| The Third People's Hospital of Chengdu (CDTPH) ( Site 0428) Chengdu, Sichuan | |
| The University of Osaka Hospital ( Site 0911) Suita, Osaka | |
| Tianjin Medical University Cancer Institute & Hospital ( Site 0392) Tianjin, Tianjin Municipality | |
| Toho University Sakura Medical Center ( Site 0906) Sakura, Chiba | |
| Tongji Hospital Tongji Medical,Science & Technology ( Site 0407) Wuhan, Hubei | |
| Turku University Hospital-Department of Oncology ( Site 0601) Turku, Southwest Finland | |
| Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 0705) Hamburg, | |
| University College London Hospital ( Site 1612) London, London, City of | |
| University Hospitals Cleveland Medical Center ( Site 0043) Cleveland, Ohio | |
| University Malaya Medical Centre ( Site 1077) Lembah Pantai, Kuala Lumpur | |
| University Of Nebraska Medical Center-Oncology/Hematology ( Site 0095) Omaha, Nebraska | |
| University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0040) Orange, California | |
| University of Chicago Medical Center ( Site 0045) Chicago, Illinois | |
| University of Colorado Health - Highlands Ranch Hospital ( Site 0111) Highlands Ranch, Colorado | |
| University of Colorado Health - Lone Tree Medical Center ( Site 0112) Lone Tree, Colorado | |
| University of Illinois at Chicago ( Site 0105) Chicago, Illinois | |
| University of Iowa ( Site 0047) Iowa City, Iowa | |
| University of Kentucky Chandler Medical Center ( Site 0048) Lexington, Kentucky | |
| University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0051) Miami, Florida | |
| University of Miyazaki Hospital ( Site 0926) Miyazaki, | |
| University of Virginia Health System ( Site 0054) Charlottesville, Virginia | |
| Universitätsklinikum Bonn-Klinik und Poliklinik für Urologie und Kinderurologie ( Site 0680) Bonn, North Rhine-Westphalia | |
| Universitätsklinikum Jena-Klinik und Poliklinik für Urologie ( Site 0682) Jena, Thuringia | |
| Universitätsklinikum Münster - Albert Schweitzer Campus-Klinik für Urologie ( Site 0678) Münster, North Rhine-Westphalia | |
| Universitätsklinikum Schleswig-Holstein-Klinik für Urologie ( Site 0691) Lübeck, Schleswig-Holstein | |
| VA Portland Health Care System ( Site 0058) Portland, Oregon | |
| VCU Health Adult Outpatient Pavillion ( Site 0061) Richmond, Virginia | |
| Vejle Sygehus ( Site 0578) Vejle, Region Syddanmark | |
| VieCuri Medisch Centrum ( Site 1173) Venlo, Limburg | |
| Washington University School of Medicine-Internal Medicine/Oncology ( Site 0062) St Louis, Missouri | |
| West China Hospital, Sichuan University-Urology Surgery ( Site 0417) Chengdu, Sichuan | |
| Westmead Hospital ( Site 0232) Westmead, New South Wales | |
| Wojewodzki Szpital Zespolony im Ludwika Rydygiera w Toruniu ( Site 1304) Torun, Kuyavian-Pomeranian Voivodeship | |
| Xinjiang Medical University Cancer Hospital - Urumqi-Urology ( Site 0419) Ürümqi, Xinjiang | |
| Yale-New Haven Hospital-Yale Cancer Center ( Site 0064) New Haven, Connecticut | |
| Yantai Yuhuangding Hospital ( Site 0397) Yantai, Shandong | |
| Yokohama City University Medical Center ( Site 0908) Yokohama, Kanagawa | |
| Yunnan Province Cancer Hospital ( Site 0418) Kunming, Yunnan | |
| Zachodniopomorskie Centrum Onkologii ( Site 1311) Szczecin, West Pomeranian Voivodeship | |
| Zhejiang Cancer Hospital ( Site 0435) Hangzhou, Zhejiang | |
| Zhejiang Provincial People's Hospital-Urology ( Site 0378) Hangzhou, Zhejiang | |
| Zuyderland Medical Centre-Trialbureau Interne Geneeskunde ( Site 1163) Sittard-Geleen, Limburg | |
| klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 0696) Munich, Bavaria |
A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial) (LIBELULA)
Debiopharm International S.A - clinicaltrials@debiopharm.com
NCT06129539
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Inclusion Criteria:
• Diagnosis of central precocious puberty.
• Onset of development of sex characteristics (i.e., breast development in girls or testicular enlargement in boys according to the Tanner method) before the age of 8 years in girls and 9 years in boys.
• Initially, only participants aged (a) 5 to 8 years inclusive (i.e., \<9 years) are eligible. The Sponsor will determine based on the recommendation of the DMC following the interim analysis whether participants aged (b) 2 to 4 years inclusive (i.e., \<5 years) and/or (c) 9 to 10 years inclusive (i.e., \<11 years) may be recruited.
• Participant to receive at least 1 year of gonadotropin-releasing hormone agonist (GnRHa) therapy from study treatment start.
• (a) Pre-treated participants: Start of initial GnRHa therapy no later than 18 months after onset of the first signs of CPP. (b) Treatment-naive participants: Start of Debio 4326 treatment no later than 18 months after onset of the first signs of CPP.
• (a) Pre-treated participants: Difference between bone age (Greulich and Pyle method) and chronological age of ≥1 year based on historical values at the initiation of the GnRHa therapy. (b) Treatment-naive participants: Difference between bone age (Greulich and Pyle method) and chronological age of ≥1 year.
• (a) Pre-treated participants: Pubertal-type LH response (LH ≥6 IU/L) following a GnRH/GnRHa stimulation test, or random non-stimulated serum LH \>0.5 IU/L (if considered local standard of care), based on historical values prior to the initiation of GnRHa therapy. (b) Treatment-naive participants: Pubertal-type LH response (≥6 IU/L) 30 minutes following a GnRHa \[leuprolide acetate 20 micrograms per kilogram (μg/kg) subcutaneous injection (SC)\] stimulation test before treatment initiation.
• (a) Pre-treated participants: Clinical evidence of puberty, defined as Tanner Staging ≥2 for breast development for girls and testicular volume ≥4 milliliter (mL) (cubic centimeter \[cc\]) for boys, prior to the initiation of GnRHa therapy. (b) Treatment-naive participants: Clinical evidence of puberty, defined as Tanner Staging ≥2 for breast development for girls and testicular volume ≥4 mL (cc) for boys.
Exclusion Criteria:
• Gonadotropin-independent (peripheral) precocious puberty: gonadotropin-independent gonadal or adrenal sex steroid secretion.
• (a) Pre-treated participants: Non-progressing, isolated premature thelarche prior to the initial GnRHa therapy. (b) Treatment-naive participants: Non-progressing, isolated premature thelarche.
• Presence of an unstable intracranial tumor or an intracranial tumor potentially requiring neurosurgery or cerebral irradiation. Participants with hamartomas not requiring surgery are eligible.
• Any other condition or chronic illness possibly interfering with growth (e.g., renal failure, diabetes, moderate to severe scoliosis, previously treated intracranial tumor).
• Other than GnRHa therapy in pre-treated participants, any ongoing treatment with a potential effect on serum levels of gonadotropins or sex steroids, or possibly interfering with growth, opioids, central nervous system \[CNS\] stimulants).
• Prior or current therapy with medroxyprogesterone acetate, growth hormone, or Insulin-like growth factor-1 (IGF-1).
• Diagnosis of short stature, i.e., more than 2.25 standard deviations (SD) below the mean height-for-age.
• Known history of seizures, epilepsy, and/or central nervous system disorders that may have been associated with seizures or convulsions.
• Prior (within 2 months of study treatment start) or current use of medications that have been associated with seizures or convulsions.
• Use of anticoagulants (heparin or coumarin derivatives). Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.
DRUG: Debio 4326
Central Precocious Puberty
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Study Locations
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| Location | Contacts |
|---|---|
| Akron Children's Hospital Akron, Ohio | |
| Ann and Robert H.Lurie Children's Hospital of Chicago Chicago, Illinois | |
| Atlanta Diabetes Associates Atlanta, Georgia | |
| CETI - Centro de Estudos em Terapias Inovadoras Ltda Curitiba, | |
| CPCLIN - Centro de Pesquisas Clínicas Ltda. São Paulo, | |
| CPQuali Pesquisa Clinica São Paulo, | |
| Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada Buenos Aires, | |
| Centro de Investigaciones Medicas Mar del Plata Mar del Plata, Buenos Aires | |
| Children's Hospital at Montefiore The Bronx, New York | |
| Christus Latam Hub Center of Excellence and Innovation S C Monterrey, | |
| Clinica Mayo de Urgencias Medicas Cruz Blanca S.R.L San Miguel de Tucumán, | |
| Clínica de Endocrinologia e Metabologia Ltda Lago Sul, | |
| ENDOMET Antofagasta, | |
| Fundação Faculdade Regional de Medicina de São José do Rio Preto Sao Jose Rio Preto, | |
| Hospital Angeles Puebla Puebla City, | |
| Hospital Clinico San Borja Arriaran (HCSBA) Santiago, | |
| Hospital Da Criança de Brasília Jose Alencar Brasília, | |
| Hospital Universitario Walter Cantidio Fortaleza, | |
| Icahn School of Medicine at Mount Sinai New York, New York | |
| Indiana University/Riley Hospital for Children Indianapolis, Indiana | |
| Instituto de Investigaciones Metabolicas (IDIM) Buenos Aires, | |
| Integral Pesquisa e Ensino Votuporanga, São Paulo | |
| Investigational Drug Service, The Children's Hospital of Philadelphia Philadelphia, Pennsylvania | |
| Irmandade Santa Casa de São Paulo São Paulo, | |
| Nemours Children's Health Pensacola, Florida | |
| Nucleo de Pesquisa Clínica do Rio Grande do Sul-NPCRS Porto Alegre, | |
| Prisma Health Pediatric Endocrinology Columbia, South Carolina | |
| Rady Children's Hospital - San Diego San Diego, California | |
| Research Institute of Dallas Dallas, Texas | |
| TMC HealthCare Tucson, Arizona | |
| Texas Children's Hospital Houston, Texas | |
| University of California San Francisco-Benioff Children's Hospital San Francisco, California | |
| University of Michigan Ann Arbor, Michigan | |
| University of Texas Southwestern Medical Center Dallas, Texas | |
| Virginia Commonwealth University Health System Richmond, Virginia | |
| Washington University St Louis, Missouri | |
| Wolfson's Children's Hospital Jacksonville, Florida |
Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymphoma
ctrrecruit@vcu.edu
NCT05602194
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Inclusion Criteria:
* \>= 15 and \< 40 years at time of diagnosis
* Newly diagnosed B-ALL, T-ALL, lymphoblastic lymphoma (LLy), or mixed-phenotype acute leukemia/lymphoma (MPAL)
* Note: Philadelphia chromosome (PH)+ and PH-like acute leukemia are eligible (use of tyrosine kinase inhibitors \[TKI\] or CRLF2- targeted concomitant medication must be documented, if used)
* Conjugated bilirubin =\< 1.5 x upper limit of normal (ULN) for age, regardless of baseline bilirubin (within 7 days prior to enrollment), and
* Serum glutamate pyruvate transaminase (SGPT) (ALT) =\< 225 U/L (=\< 5x ULN) (within 7 days prior to enrollment), and
* Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L and serum glutamic oxaloacetic transaminase (SGOT) (AST) to 50 U/L regardless of baseline
* SGOT (AST) =\< 250 U/L (=\< 5x ULN) (within 7 days prior to enrollment)
* Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L and SGOT (AST) to 50 U/L regardless of baseline
* For patients receiving ursodiol prior to enrollment, laboratory values must meet above criteria off ursodiol for 7 days
* PEDIATRIC PATIENTS (AGE 15-17 years):
* A 24-hour urine creatinine clearance \>= 30 mL/min/1.73 m\^2 (within 7 days prior to enrollment) OR
* A glomerular filtration rate (GFR) \>= 30 mL/min/1.73 m\^2. GFR must be performed using one of the following methods (within 7 days prior to enrollment):
* 1\. Estimated GFR (eGFR) \>= 30 mL/min/1.73 m\^2.
* An online calculator is available through the National Kidney Foundation at https://www.kidney.org/professionals/kdoqi/gfr\_calculatorped
* 2\. Measured GFR \>= 30 mL/min/1.73 m\^2 (any age). If measured GFR is used, it must be performed using direct measurement with a nuclear blood sampling method or small molecule clearance method (iothalamate or other molecule per institutional standard).
* ADULT PATIENTS (AGE 18 YEARS OR OLDER): Creatinine clearance \>= 30 mL/min, as estimated by the Cockcroft and Gault formula or a 24-hour urine collection (within 7 days prior to enrollment). Estimated creatinine clearance is based on actual body weight
* An online calculator is available through the National Kidney Foundation at https://www.kidney.org/professionals/kdoqi/gfr\_calculatorcoc
* Berlin-Frankfurt-Munich (BFM), Children's Oncology Group (COG), or C10403-based Induction regimen and must be inclusive of \>= 1 dose of pegaspargase or calaspargase pegol, and
* First dose of asparaginase must be planned within the first week of induction therapy, and
* Dose of pegaspargase or calaspargase pegol must be \>= 1,000 IU/ m\^2 (dose-capping permitted per primary regimen)
* Note: Co-enrollment on a therapeutic consortia trial is not required
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
* Down syndrome
* Known inherited or autoimmune liver disease impacting conjugated bilirubin (e.g., Alagille syndrome, primary sclerosing cholangitis, other)
* Known biopsy (or imaging) proven severe liver fibrosis (Batts-Ludwig \>= stage 3)
* Unable to tolerate oral formulation of study drug at enrollment
* Patients who received chemotherapy or treatment for a prior malignancy are not eligible
* The following are permitted: steroid prophase, hydroxyurea, or other cytoreduction prior to initiation of Induction chemotherapy (must be documented) and chemotherapy for current diagnosis (i.e. initiation of Induction therapy within enrollment window). Chemotherapy prior to enrollment for treatment of a non-malignancy (e.g., steroid or methotrexate for autoimmune disease) is also permitted and must be documented
* Female patients who are pregnant since fetal toxicities and teratogenic effects in humans are unknown for study drug. A pregnancy test is required for female patients of childbearing potential
* Lactating females who plan to breastfeed their infants
* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation PROCEDURE: Biospecimen Collection, DRUG: Calaspargase Pegol, DIETARY_SUPPLEMENT: Levocarnitine, DRUG: Pegaspargase, OTHER: Quality-of-Life Assessment
B Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia With t(9,22)(q34.1,q11.2), BCR-ABL1, B Acute Lymphoblastic Leukemia, BCR-ABL1-Like, Lymphoblastic Lymphoma, Mixed Phenotype Acute Leukemia, T Acute Lymphoblastic Leukemia
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Show 221 locations
Study Locations
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| Location | Contacts |
|---|---|
| AdventHealth Orlando Orlando, Florida | Site Public Contact - (FH.Cancer.Research@flhosp.org) |
| Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois | |
| Advocate Children's Hospital-Park Ridge Park Ridge, Illinois | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Albany Medical Center Albany, New York | |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.org) |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Ann M Wierman MD LTD Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Ascension Saint Vincent Indianapolis Hospital Indianapolis, Indiana | Site Public Contact - (research@stvincent.org) |
| Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora BayCare Medical Center Green Bay, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
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Effect of Clear Aligner Attachment Size on Extrusion of Maxillary Lateral Incisors
Alexis Catalano - catalanoam2@vcu.edu
NCT06814262
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Inclusion Criteria:
* Patients treated with either Comprehensive Invisalign or Invisalign Teen treatment
* The maxillary arch has less than 6 mm of crowding or spacing
* Maxillary lateral incisors have a minimum of 0.3 mm of extrusion prescribed in the Tooth Movement Table on the Invisalign ClinCheck for the first set of aligners
* Maxillary lateral incisors within a normal range of bucco-lingual inclination
* Patients 12 years of age or older and either the patient or legal guardian are able to give consent
* Patients confirm good compliance throughout the study period
Exclusion Criteria:
* Patients do not complete all aligners in the first phase as prescribed
* Poor compliance recorded for aligner wear
* Restorations placed or oral surgery completed prior to final scan
* Midcourse intervention to improve tracking such as a bootstrap
* Maxillary lateral incisors not tracking and noted by minimum of 1 mm of aligner material incisally displaced when aligner fully seated
* Treatment plans include surgery or extractions
* Maxillary lateral incisors with pathology and restorations
* Missing teeth other than third molars
* Patients with anterior crossbite DEVICE: Corresponding treatment order in the prescription with Align Technology, DEVICE: Superimposition of final and initial positions of lateral incisors: Predicted model, DEVICE: Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x3mm aligners, DEVICE: Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x4mm aligners, DEVICE: Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x5mm aligners
Orthodontic Appliance Complication
Extrusion of Maxillary Lateral Incisors, Clear Aligner Attachment
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Study Locations
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Alexis Catalano - (catalanoam2@vcu.edu) Steven Lindauer - (sjlindau@vcu.edu) |
A Study With Tovorafenib (DAY101) as a Treatment Option for Progressive, Relapsed, or Refractory Langerhans Cell Histiocytosis
ctrrecruit@vcu.edu
NCT05828069
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Inclusion Criteria:
* 180 days- \< 22 years (at time of study enrollment)
* Patient must have a body surface area of ≥ 0.3 m\^2
* Patients with progressive, relapsed, or recurrent LCH with measurable disease at study entry
* Patients must have had histologic verification of LCH (from either original diagnosis or relapse/progression) at the time of study entry (must be obtained within 28 days prior to enrollment and start of protocol therapy) (repeat if necessary)
* Tissue confirmation of relapse is recommended but not required
* Pathology report must be submitted for central confirmation of diagnosis within 7 days of enrollment.
* Formalin-fixed paraffin-embedded (FFPE) blocks or unstained slides (initial diagnosis and/or subsequent biopsies) will be required for retrospective central confirmation of diagnosis and molecular studies
* Patients with mixed histiocytic disorders (e.g. LCH with juvenile xanthogranuloma) may be included
* Patients must have measurable disease, documented by radiographic imaging (LCH- specific response criteria (must be obtained within 28 days prior to enrollment and start of protocol therapy) (repeat if necessary).
* Patients must have progressive or refractory disease or experience relapse after at least one previous systemic treatment strategy
* Pathogenic somatic mutation detected in genes encoding tyrosine kinase receptors (CSFR1, ERBB3 or ALK), RAS or RAF (may be from original or subsequent biopsy or peripheral blood/bone marrow aspirate). Clinical mutation reports may include quantitative polymerase chain reaction (PCR) (e.g. BRAFV600E) and/or Sanger or next generation sequencing. Immunohistochemistry (e.g. VE1 antibody for BRAFV600E) alone is not sufficient
* Participant must be able to take an enteral dose and formulation of medication. Study medication is only available as an oral suspension or tablet, which may be taken by mouth or other enteral route such as nasogastric, jejunostomy, or gastric tube
* Karnofsky \>= 50% for patients \> 16 years of age and Lansky \>= 50% for patients =\< 16 years of age
* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \> 16 years of age and Lansky for patients =\< 16 years of age
* Myelosuppressive chemotherapy: Patients must not have received within 14 days of entry onto this study
* Investigational agent or any other anticancer therapy not defined above: Patients must not have received any investigational agent or any other anticancer therapy (including MAPK pathway inhibitor) for at least 14 days prior to planned start of tovorafenib (DAY101)
* Radiation therapy (RT): Patient must not have received RT within 2 weeks after the last dose fraction of RT
* Patients must have fully recovered from any prior surgery
* Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, targeted inhibitor, and/or radiotherapy with toxicities reduced to grade 1 or less (Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0)
* Steroids: =\< 0.5 mg/kg/day of prednisone equivalent (maximum 20 mg/day) averaged during the month prior to study enrollment is permissible
* Strong inducers or inhibitors of CYP2C8 are prohibited for 14 days before the first dose of tovorafenib (DAY101) and from planned administration for the duration of study participation
* Medications that are breast cancer resistant protein (BCRP) substrates that have a narrow therapeutic index are prohibited for 14 days before the first dose of tovorafenib (DAY101) and for the duration of study participation
* Peripheral absolute neutrophil count (ANC) \>= 750/uL unless secondary to bone marrow involvement, in such cases bone marrow involvement must be documented (must be performed within 7 days prior to enrollment, must be repeated prior to the start of protocol therapy if \> 7 days have elapsed from their most recent prior assessment)
* Platelet count \>= 75,000/uL (unsupported/without transfusion within the past 7 days) (must be performed within 7 days prior to enrollment, must be repeated prior to the start of protocol therapy if \> 7 days have elapsed from their most recent prior assessment)
* Patients with marrow disease must have platelet count of \>= 75,000/uL (transfusion support allowed) and must not be refractory to platelet transfusions. Bone marrow involvement must be documented
* Hemoglobin \>= 8 g/dL (unsupported/without transfusion within the past 7 days). Patients with marrow disease must have hemoglobin \>= 8 g/dL (transfusion support allowed). Bone marrow involvement must be documented
* Hematopoietic growth factors: At least 14 days after the last dose of a long-acting growth factor (e.g., Neulasta \[registered trademark\]) or 7 days for short-acting growth factor
* A serum creatinine based on age/sex as follows (must be performed within 7 days prior to enrollment, must be repeated prior to the start of protocol therapy if \> 7 days have elapsed from their most recent prior assessment)
* Age: 6 months to \< 1 year; Maximum Serum Creatinine (mg/dL):= 0.5 mg/dl (male and female)
* Age: 1 to \< 2 years; Maximum Serum Creatinine (mg/dL): = 0.6 mg/dl (male and female)
* Age: 2 to \< 6 years; Maximum Serum Creatinine (mg/dL): = 0.8 mg/dl (male and female)
* Age: 6 to \< 10 years; Maximum Serum Creatinine (mg/dL): = 1.0 mg/dl (male and female)
* Age: 10 to \< 13 years; Maximum Serum Creatinine (mg/dL): = 1.2 mg/dl (male and female)
* 13 to \< 16 years; Maximum Serum Creatinine (mg/dL): = 1.5 mg/dl (male) and 1.4 mg/dl (female)
* Age: \>= 16 years; Maximum Serum Creatinine (mg/dL): = 1.7 mg/dl (male) and 1.4 mg/dl (female)
* OR- a 24 hour urine creatinine clearance \>= 50 mL/min/1.73 m\^2
* OR- a glomerular filtration rate (GFR) \>= 50 mL/min/1.73 m\^2. GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard)
* Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility
* Bilirubin (sum of conjugated + unconjugated) =\< 1.5 x upper limit of normal (ULN) for age (must be performed within 7 days prior to enrollment, must be repeated prior to the start of protocol therapy if \> 7 days have elapsed from their most recent prior assessment)
* Alanine aminotransferase (ALT) =\< 3 x ULN for age (must be performed within 7 days prior to enrollment, must be repeated prior to the start of protocol therapy if \> 7 days have elapsed from their most recent prior assessment)
* Serum albumin \>= 2 g/dl must be performed within 7 days prior to enrollment, must be repeated prior to the start of protocol therapy if \> 7 days have elapsed from their most recent prior assessment)
* For patients with liver disease caused by their histiocytic disorder (as evaluated on radiographic imaging or biopsy): patients may be enrolled with abnormal bilirubin, aspartate aminotransferase (AST), ALT and albumin with documentation of histiocytic liver disease
* Fractional shortening (FS) of \>= 25% or ejection fraction of \>= 50%, as determined by echocardiography or multigated acquisition scan (MUGA) within 28 days prior to study enrollment. Depending on institutional standard, either FS or left ventricular ejection fraction (LVEF) is adequate for enrollment if only one value is measured; if both values are measured, then both values must meet criteria above (must be obtained within 28 days prior to enrollment and start of protocol therapy) (repeat if necessary)
* No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \> 94% if there is clinical indication for determination; unless it is due to underlying pulmonary LCH
* Central Nervous System Function Defined As:
* Patients with seizure disorder may be enrolled if well controlled
* Central nervous system (CNS) toxicity =\< Grade 2
* Human immunodeficiency virus (HIV) infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial unless antiretroviral therapy interacts with the metabolism of tovorafenib (DAY101) and cannot safely be changed to antivirals that do not interact with study medication
Exclusion Criteria:
* LCH arising along with other hematologic malignancy (e.g. mixed LCH with acute lymphoblastic leukemia) or any history of non-histiocytic malignancy
* Disease scenarios as below will be excluded
* Skin-limited disease
* Gastrointestinal (GI) tract involvement only (those that have disease that can be determined by endoscopic biopsies only)
* LCH-associated neurodegeneration (LCH-ND) without parenchymal lesions or other systemic lesions
* Patients with activating mutations in MAP2K1 are not eligible for this study due to drug target specificity. Mutation status will be submitted to study team within 7 days of enrollment
* Refractory nausea and vomiting, malabsorption, or external biliary shunt that would preclude adequate absorption of tovorafenib (DAY101)
* Uncontrolled systemic bacterial, viral, or fungal infection
* Major surgical procedure or significant traumatic injury within 14 days prior to study enrollment, or anticipation of need for major surgical procedure during the course of the study. Placement of a vascular access device or minor surgery is permitted within fourteen (14) days of study enrollment (provided that the wound has healed)
* History of significant bowel resection that would preclude adequate absorption or other significant malabsorptive disease
* Ophthalmologic considerations: Patients with known significant ophthalmologic conditions or known risk factors for retinal vein occlusion (RVO) or central serous retinopathy (CSR) are not eligible
* History of solid organ or hematopoietic bone marrow transplantation
* Clinically significant active cardiovascular disease, or history of myocardial infarction, or deep vein thrombosis/pulmonary embolism within 6 months prior to enrollment, ongoing cardiomyopathy, or current prolonged QT interval \> 440 ms based on triplicate electrocardiogram (ECG) average
* History of Grade \>= 2 CNS hemorrhage or history of any CNS hemorrhage within 28 days of study entry
* History of any drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome or Stevens Johnsons syndrome (SJS) or who are allergic to tovorafenib (DAY101) or any of its components
* CTCAE version (V). 5.0 Grade 3 symptomatic creatinine kinase (CPK) elevation ( \> 5 x ULN)
* Female patients who are pregnant are ineligible. A pregnancy test is required for female patients of childbearing potential
* Lactating females who plan to breastfeed their infants are ineligible
* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation are ineligible. Women of childbearing potential must use non-hormonal contraception during tovorafenib treatment and for at least 28 days after the last dose. Men should use effective contraception and must not father a child while taking tovorafenib and for 14 days after the last dose PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, PROCEDURE: Computed Tomography, PROCEDURE: Echocardiography Test, PROCEDURE: FDG-Positron Emission Tomography and Computed Tomography Scan, PROCEDURE: Lumbar Puncture, PROCEDURE: Multigated Acquisition Scan, DRUG: Tovorafenib
Recurrent Langerhans Cell Histiocytosis, Refractory Langerhans Cell Histiocytosis
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Show 106 locations
Study Locations
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| Location | Contacts |
|---|---|
| Albany Medical Center Albany, New York | |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.org) |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Arnold Palmer Hospital for Children Orlando, Florida | Site Public Contact - (Jennifer.spinelli@orlandohealth.com) |
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Blank Children's Hospital Des Moines, Iowa | Site Public Contact - (samantha.mallory@unitypoint.org) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) Québec, | Site Public Contact - (rechclinique@crchudequebec.ulaval.ca) |
| Cardinal Glennon Children's Medical Center St Louis, Missouri | |
| Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec | Site Public Contact - (yvan.samson@umontreal.ca) |
| Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec | Site Public Contact - (crcinformation.chus@ssss.gouv.qc.ca) |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia | Site Public Contact - (Olivia.Floyd@choa.org) |
| Children's Hospital London, Ontario | |
| Children's Hospital Colorado Aurora, Colorado | Site Public Contact - (josh.b.gordon@nsmtp.kp.org) |
| Children's Hospital Los Angeles Los Angeles, California | |
| Children's Hospital New Orleans New Orleans, Louisiana | |
| Children's Hospital and Medical Center of Omaha Omaha, Nebraska | |
| Children's Hospital of Alabama Birmingham, Alabama | Site Public Contact - (oncologyresearch@peds.uab.edu) |
| Children's Hospital of Orange County Orange, California | Site Public Contact - (oncresearch@choc.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Site Public Contact - (CancerTrials@email.chop.edu) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Site Public Contact - (jean.tersak@chp.edu) |
| Children's Hospital of San Antonio San Antonio, Texas | Site Public Contact - (bridget.medina@christushealth.org) |
| Children's Hospital of the King's Daughters Norfolk, Virginia | Site Public Contact - (CCBDCresearch@chkd.org) |
| Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota | Site Public Contact - (pauline.mitby@childrensmn.org) |
| Children's National Medical Center Washington D.C., District of Columbia | Site Public Contact - (OncCRC_OnCall@childrensnational.org) |
| Connecticut Children's Medical Center Hartford, Connecticut | |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Dayton Children's Hospital Dayton, Ohio | |
| Dell Children's Medical Center of Central Texas Austin, Texas | Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org) |
| Duke University Medical Center Durham, North Carolina | |
| East Carolina University Greenville, North Carolina | Site Public Contact - (eubankss@ecu.edu) |
| East Tennessee Childrens Hospital Knoxville, Tennessee | |
| El Paso Children's Hospital El Paso, Texas | Site Public Contact - (ranjan.bista@ttuhsc.edu) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Golisano Children's Hospital of Southwest Florida Fort Myers, Florida | Site Public Contact - (molly.arnstrom@leehealth.org) |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Hospital for Sick Children Toronto, Ontario | Site Public Contact - (ask.CRS@sickkids.ca) |
| IWK Health Centre Halifax, Nova Scotia | Site Public Contact - (Research@iwk.nshealth.ca) |
| Kaiser Permanente Downey Medical Center Downey, California | |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | Site Public Contact - (CancerTrials@nyulangone.org) |
| Loma Linda University Medical Center Loma Linda, California | |
| Lucile Packard Children's Hospital Stanford University Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| Lurie Children's Hospital-Chicago Chicago, Illinois | |
| M D Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| Maimonides Medical Center Brooklyn, New York | |
| McMaster Children's Hospital at Hamilton Health Sciences Hamilton, Ontario | |
| Memorial Health University Medical Center Savannah, Georgia | Site Public Contact - (Lorraine.OHara@hcahealthcare.com) |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Methodist Children's Hospital of South Texas San Antonio, Texas | Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com) |
| Michigan State University East Lansing, Michigan | |
| Mission Hospital Asheville, North Carolina | Site Public Contact - (NCDV.ResearchRegulatory@HCAHealthcare.com) |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York | Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu) |
| NYP/Weill Cornell Medical Center New York, New York | |
| Nationwide Children's Hospital Columbus, Ohio | Site Public Contact - (Melinda.Triplet@nationwidechildrens.org) |
| Nemours Children's Clinic-Jacksonville Jacksonville, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| Nemours Children's Hospital Orlando, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| New York Medical College Valhalla, New York | |
| Nicklaus Children's Hospital Miami, Florida | |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Perth Children's Hospital Perth, Western Australia | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Primary Children's Hospital Salt Lake City, Utah | |
| Prisma Health Richland Hospital Columbia, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington | Site Public Contact - (HopeBeginsHere@providence.org) |
| Queensland Children's Hospital South Brisbane, Queensland | |
| Rainbow Babies and Childrens Hospital Cleveland, Ohio | |
| Riley Hospital for Children Indianapolis, Indiana | |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado | Site Public Contact - (PSGResearchSharedMailbox@HCAHealthcare.com) |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey | |
| Saint Christopher's Hospital for Children Philadelphia, Pennsylvania | |
| Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida | Site Public Contact - (jennifer.manns@baycare.org) |
| Saint Joseph's Regional Medical Center Paterson, New Jersey | Site Public Contact - (HallL@sjhmc.org) |
| Saint Jude Midwest Affiliate Peoria, Illinois | |
| Scott and White Memorial Hospital Temple, Texas | |
| Seattle Children's Hospital Seattle, Washington | |
| Sinai Hospital of Baltimore Baltimore, Maryland | |
| Summerlin Hospital Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Sydney Children's Hospital Randwick, New South Wales | |
| The Children's Hospital at TriStar Centennial Nashville, Tennessee | |
| The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York | |
| UCSF Benioff Children's Hospital Oakland Oakland, California | Site Public Contact - (cogbchoak@ucsf.edu) |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University of Alberta Hospital Edmonton, Alberta | Site Public Contact - (pedsoncologyresearch@ahs.ca) |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Florida Health Science Center - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Texas Health Science Center at San Antonio San Antonio, Texas | Site Public Contact - (phoresearchoffice@uthscsa.edu) |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Children's Hospital Madera, California | Site Public Contact - (Research@valleychildrens.org) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| West Virginia University Charleston Division Charleston, West Virginia | |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab
ctrrecruit@vcu.edu
NCT05675410
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Inclusion Criteria:
* Patients must be 5 to 60 years of age at the time of enrollment
* Patients with newly diagnosed untreated histologically confirmed classic Hodgkin lymphoma (cHL) (nodular sclerosis, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified \[NOS\]) with stage I or II disease
* Patients must have bidimensionally measurable disease (at least one lesion with longest diameter \>= 1.5 cm)
* Patients must have a whole body or limited whole body PET scan performed within 42 days prior to enrollment. PET-CT is strongly preferred. PET-MRI allowed if intravenous contrast enhanced CT is also obtained
* Pediatric patients (age 5-17 years) with known or suspected mediastinal disease must have an upright posteroanterior (PA) chest X-ray (CXR) for assessment of bulky mediastinal disease.
* Note: Pediatric patients who have received both a CT chest and upright PA CXR may meet the definition of bulk through either modality.
* Patients \>= 18 years must have a performance status corresponding to Zubrod scores of 0, 1 or 2
* Patients =\< 17 years of age must have a Lansky performance score of \>= 50
* Pediatric patients (age 5-17 years): A serum creatinine based on age/gender as follows (within 28 days prior to enrollment):
* 2 to \< 6 years (age): 0.8 mg/dL (male), 0.8 mg/dL (female)
* 6 to \< 10 years (age): 1 mg/dL (male), 1 mg/dL (female)
* 10 to \< 13 years (age): 1.2 mg/dL (male), 1.2 mg/dL (female)
* 13 to \< 16 years (age): 1.5 mg/dL (male), 1.4 mg/dL (female)
* \>= 16 years (age): 1.7 mg/dL (male), 1.4 mg/dL (female) OR a 24 hour urine creatinine clearance \>= 50 mL/min/1.73 m\^2 (within 28 days prior to enrollment) OR a glomerular filtration rate (GFR) \>= 50 mL/min/1.73 m\^2 (within 28 days prior to enrollment). GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard)
* Note: Estimated GFR (eGFR) from serum or plasma creatinine, cystatin C or other estimates are not acceptable for determining eligibility
* For adult patients (age 18 years or older) (within 28 days prior to enrollment): Creatinine clearance \>= 30 mL/min, as estimated by the Cockcroft and Gault formula or a 24-hour urine collection. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight
* Total bilirubin =\< 2 x upper limit of normal (ULN) (within 28 days prior to enrollment)
* Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome
* Aspartate aminotransferase (AST) =\< 3 x ULN (within 28 days prior to enrollment)
* Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome
* Alanine aminotransferase (ALT) =\< 3 x ULN (within 28 days prior to enrollment)
* Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome
* Shortening fraction of \>= 27% by echocardiogram (ECHO), multigated acquisition scan (MUGA), or functional cardiac imaging scan (within 28 days prior to enrollment) or ejection fraction of \>= 50% by radionuclide angiogram, ECHO, MUGA, or cardiac imaging scan (within 28 days prior to enrollment)
* Diffusion capacity of the lung for carbon monoxide (DLCO) \>= 50% of predicted value as corrected for hemoglobin by pulmonary function test (PFT) (within 28 days prior to enrollment). If unable to obtain PFTs, the criterion is: a pulse oximetry reading of \> 92% on room air
* Known human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Exclusion Criteria:
* Patients with nodular lymphocyte predominant Hodgkin lymphoma
* Patients with a history of active interstitial pneumonitis or interstitial lung disease
* Patients with a diagnosis of inherited or acquired immunodeficiency that is poorly controlled or requiring active medications, such as primary immunodeficiency syndromes or organ transplant recipients
* Patients with any known uncontrolled intercurrent illness that would jeopardize the patient's safety such as infection, autoimmune conditions, cardiac arrhythmias, angina pectoris, and gastrointestinal disorders affecting swallowing and/or absorption of pills
* Patients with a condition requiring systemic treatment with either corticosteroids (defined as equivalent to \> 10 mg daily predniSONE for patients \>= 18 years or \> 0.5 mg/kg \[up to 10 mg/day\] for patients \< 18 years) or other immunosuppressive medications within 14 days prior to enrollment
* Note: Replacement therapy such as thyroxine, insulin, or physiologic corticosteroid for adrenal or pituitary insufficiency is not considered a form of systemic treatment. Inhaled or topical steroids, and adrenal replacement doses (=\< 10 mg daily for patients \>= 18 years or =\< 0.5 mg/kg \[up to 10 mg/day\] predniSONE equivalents) are permitted in the absence of active autoimmune disease
* Note: Steroid use for the control of Hodgkin lymphoma symptoms is allowable, but must be discontinued by cycle 1, day 1
* Short term use of corticosteroids for premedication or treatment of an allergy or hypersensitivity is considered an acceptable use of corticosteroids.
* Patients with peripheral neuropathy \> grade 1 at the time of enrollment or patients with known Charcot-Marie-Tooth syndrome
* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen
* Administration of prior chemotherapy, radiation, or antibody-based treatment for cHL
* Prior solid organ transplant
* Prior allogeneic stem cell transplantation
* Live vaccine within 30 days prior to planned day 1 of protocol therapy (e.g., measles, mumps, rubella, varicella, yellow fever, rabies, bacillus Calmette Guerin \[BCG\], oral polio vaccine, and oral typhoid). Administration of messenger ribonucleic acid (mRNA) vaccines are permitted
* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test within 28 days prior to enrollment is required for female patients of childbearing potential
* Lactating females who plan to breastfeed their infants starting with the first dose of study therapy and for at least 6 months after the last treatment
* Sexually active patients of reproductive potential who have not agreed to use a highly effective contraceptive method for the duration of their study drug therapy. Following therapy, patients will be advised to use contraception as per institutional practice or as listed below for investigational agents, whichever is longer
* Men and women of childbearing potential must continue contraception for a period of 6 months after last dose of brentuximab vedotin
* Women of child-bearing potential (WOCBP) must continue contraception for a period of at least 5 months after the last dose of nivolumab
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met PROCEDURE: Biospecimen Collection, BIOLOGICAL: Bleomycin Sulfate, DRUG: Brentuximab Vedotin, PROCEDURE: Computed Tomography, DRUG: Cyclophosphamide, DRUG: Dacarbazine, DRUG: Doxorubicin Hydrochloride, DRUG: Etoposide, DRUG: Etoposide Phosphate, OTHER: Fludeoxyglucose F-18, RADIATION: Involved-site Radiation Therapy, PROCEDURE: Magnetic Resonance Imaging, BIOLOGICAL: Nivolumab, PROCEDURE: Positron Emission Tomography, DRUG: Prednisolone, DRUG: Prednisone, DRUG: Procarbazine Hydrochloride, OTHER: Questionnaire Administration, DRUG: Vinblastine Sulfate, DRUG: Vincristine Sulfate
Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8
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Show 356 locations
Study Locations
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| Location | Contacts |
|---|---|
| AMG Crystal Lake - Oncology Crystal Lake, Illinois | Site Public Contact - (advocateresearch@advocate.com) |
| AMG Libertyville - Oncology Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| AdventHealth Orlando Orlando, Florida | Site Public Contact - (FH.Cancer.Research@flhosp.org) |
| Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois | |
| Advocate Children's Hospital-Park Ridge Park Ridge, Illinois | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Advocate Christ Medical Center Oak Lawn, Illinois | |
| Advocate Good Samaritan Hospital Downers Grove, Illinois | Site Public Contact - (Barbara.barhamand@advocatehealth.com) |
| Advocate Good Shepherd Hospital Barrington, Illinois | |
| Advocate Illinois Masonic Medical Center Chicago, Illinois | |
| Advocate Lutheran General Hospital Park Ridge, Illinois | |
| Advocate Sherman Hospital Elgin, Illinois | |
| Advocate South Suburban Hospital Hazel Crest, Illinois | |
| Albany Medical Center Albany, New York | |
| Alberta Children's Hospital Calgary, Alberta | |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.org) |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Arnold Palmer Hospital for Children Orlando, Florida | Site Public Contact - (Jennifer.spinelli@orlandohealth.com) |
| Ascension Saint Vincent Indianapolis Hospital Indianapolis, Indiana | Site Public Contact - (research@stvincent.org) |
| Atrium Health Navicent Macon, Georgia | Site Public Contact - (andrew.weatherall@atriumhealth.org) |
| Augusta University Medical Center Augusta, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora BayCare Medical Center Green Bay, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Grafton Grafton, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Kenosha South Kenosha, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Racine Racine, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Health Care Germantown Health Center Germantown, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Medical Center in Summit Summit, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's South Shore Cudahy, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Sinai Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora West Allis Medical Center West Allis, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Beacon Kalamazoo Cancer Center Kalamazoo, Michigan | |
| Blank Children's Hospital Des Moines, Iowa | Site Public Contact - (samantha.mallory@unitypoint.org) |
| Bronson Battle Creek Battle Creek, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Broward Health Medical Center Fort Lauderdale, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| C S Mott Children's Hospital Ann Arbor, Michigan | |
| CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) Québec, | Site Public Contact - (rechclinique@crchudequebec.ulaval.ca) |
| CTCA at Western Regional Medical Center Goodyear, Arizona | |
| Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan | Site Public Contact - (connie.szczepanek@crcwm.org) |
| CancerCare Manitoba Winnipeg, Manitoba | Site Public Contact - (ctu_web@cancercare.mb.ca) |
| Cardinal Glennon Children's Medical Center St Louis, Missouri | |
| Carilion Children's Roanoke, Virginia | Site Public Contact - (wpmccarty@carilionclinic.org) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Cedars Sinai Medical Center Los Angeles, California | |
| Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec | Site Public Contact - (yvan.samson@umontreal.ca) |
| Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec | Site Public Contact - (crcinformation.chus@ssss.gouv.qc.ca) |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia | Site Public Contact - (Olivia.Floyd@choa.org) |
| Children's Hospital London, Ontario | |
| Children's Hospital Colorado Aurora, Colorado | Site Public Contact - (josh.b.gordon@nsmtp.kp.org) |
| Children's Hospital Los Angeles Los Angeles, California | |
| Children's Hospital Medical Center Of Akron Akron, Ohio | |
| Children's Hospital New Orleans New Orleans, Louisiana | |
| Children's Hospital Of Eastern Ontario Ottawa, Ontario | |
| Children's Hospital and Medical Center of Omaha Omaha, Nebraska | |
| Children's Hospital of Alabama Birmingham, Alabama | Site Public Contact - (oncologyresearch@peds.uab.edu) |
| Children's Hospital of Michigan Detroit, Michigan | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Orange County Orange, California | Site Public Contact - (oncresearch@choc.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Site Public Contact - (CancerTrials@email.chop.edu) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Site Public Contact - (jean.tersak@chp.edu) |
| Children's Hospital of San Antonio San Antonio, Texas | Site Public Contact - (bridget.medina@christushealth.org) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | Site Public Contact - (MACCCTO@mcw.edu) |
| Children's Hospital of the King's Daughters Norfolk, Virginia | Site Public Contact - (CCBDCresearch@chkd.org) |
| Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota | Site Public Contact - (pauline.mitby@childrensmn.org) |
| Children's Mercy Hospitals and Clinics Kansas City, Missouri | Site Public Contact - (rryan@cmh.edu) |
| Children's National Medical Center Washington D.C., District of Columbia | Site Public Contact - (OncCRC_OnCall@childrensnational.org) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@cchmc.org) |
| City of Hope Antelope Valley Lancaster, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope Comprehensive Cancer Center Duarte, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope Corona Corona, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope Newport Beach Newport Beach, California | |
| City of Hope Seacliff Huntington Beach, California | |
| City of Hope South Bay Torrance, California | |
| City of Hope South Pasadena South Pasadena, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope Upland Upland, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope at Irvine Lennar Irvine, California | |
| City of Hope at Long Beach Elm Long Beach, California | |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Community Medical Center Toms River, New Jersey | Site Public Contact - (Lennette.Gonzales@rwjbh.org) |
| Condell Memorial Hospital Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Connecticut Children's Medical Center Hartford, Connecticut | |
| Cook Children's Medical Center Fort Worth, Texas | Site Public Contact - (CookChildrensResearch@cookchildrens.org) |
| Cooper Hospital University Medical Center Camden, New Jersey | |
| Corewell Health Beaumont Troy Hospital Troy, Michigan | |
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| Corewell Health Dearborn Hospital Dearborn, Michigan | |
| Corewell Health Farmington Hills Hospital Farmington Hills, Michigan | |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Reed City Hospital Reed City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health William Beaumont University Hospital Royal Oak, Michigan | |
| Covenant Children's Hospital Lubbock, Texas | Site Public Contact - (mbisbee@providence.org) |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
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| Dell Children's Medical Center of Central Texas Austin, Texas | Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org) |
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| Duke University Medical Center Durham, North Carolina | |
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| East Tennessee Childrens Hospital Knoxville, Tennessee | |
| Eastern Maine Medical Center Bangor, Maine | |
| Edward Hospital/Cancer Center Naperville, Illinois | |
| Edward Hospital/Cancer Center?Plainfield Plainfield, Illinois | Site Public Contact - (Cancerresearch@edward.org) |
| Edwards Comprehensive Cancer Center Huntington, West Virginia | Site Public Contact - (Christina.Cole@chhi.org) |
| El Paso Children's Hospital El Paso, Texas | Site Public Contact - (ranjan.bista@ttuhsc.edu) |
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| Grady Health System Atlanta, Georgia | |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | Site Public Contact - (cancerctr@gundersenhealth.org) |
| HSHS Saint Elizabeth's Hospital O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Hackensack University Medical Center Hackensack, New Jersey | |
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| Siteman Cancer Center at Christian Hospital St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
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| Smilow Cancer Hospital Care Center - Guilford Guilford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
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| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Yale-New Haven Hospital North Haven Medical Center North Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Trial Readiness and Endpoint Assessment in Pediatric Myotonic Dystrophy Extension (TREAT-EXT)
Ruby Langeslay, MPH - Ruby.Langeslay@vcuhealth.org
NCT06747884
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Inclusion Criteria (Congenital Myotonic Dystrophy Group):
* Age 5-17 years, 11 months at enrollment. Lower age limit not applicable for participants who have completed ASPIRE-DM1 protocol. Upper age limit not applicable for participants who previously participated in TREAT-01-001 (TREAT-CDM) study
* A diagnosis of CDM, defined as: children having symptoms of myotonic dystrophy in the newborn period (\<30 days), such as hypotonia, feeding or respiratory difficulty, requiring hospitalization to a ward or to the neonatal intensive care unit for more than 72 hours; and a genetic test confirming an expanded trinucleotide (CTG) repeat in the DMPK gene in the child or mother. An expanded CTG repeat size in the child is considered greater than 200 repeats or E1-E4 classification (E1= 200-500, E2=500-1,000, E3=1,000-1,500, E4\>1,500).
* Written, voluntary informed consent must be obtained before any study related procedures are conducted.
Inclusion Criteria (Childhood Myotonic Dystrophy Group):
* Age 3-17 years, 11 months at enrollment. Upper age limit not applicable for participants who previously participated in TREAT-01-001 (TREAT-CDM) study.
* A diagnosis of ChDM, defined as: children having cognitive deficits, muscle weakness, myotonia that developed after age 1 and prior to age 10 and a genetic test confirming an expanded trinucleotide (CTG) repeat in the DMPK gene in the child or mother. An expanded CTG repeat size in the child is considered greater than 200 repeats or E1-E4 classification (E1= 200-500, E2=500-1,000, E3=1,000-1,500, E4\>1,500).
* Written, voluntary informed consent must be obtained before any study related procedures are conducted.
Exclusion Criteria:
* Any other non-DM1 illness that would interfere with the ability to undergo safe testing or would affect the interpretation of the results, in the opinion of the site investigator
* Significant trauma within the past month
* Internal metal or devices (exclusion for DEXA component)
* Use of anticoagulants, such as warfarin or a direct oral anticoagulant (e.g., dabigatran) due to the increased risk of bleeding with biopsy
* Platelet count \<50,000
* History of a bleeding disorder
* Participation in a clinical trial involving an investigational product
* History of adverse reaction to lidocaine (if participating in muscle biopsy) Congenital Myotonic Dystrophy, Childhood Myotonic Dystrophy, Myotonic Dystrophy
DM1, Childhood Myotonic Dystrophy, Congenital Myotonic Dystrophy, Myotonic Dystrophy, Myotonia, Dystrophy Myotonic, DMCRN, TREAT-EXT, TREAT CDM
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Study Locations
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Shantel Kyles - (shantel.brown@vcuhealth.org) Levi Headrick - (levi.headrick@vcuhealth.org) |
AFFINITY DUCHENNE: RGX-202 Gene Therapy in Participants With Duchenne Muscular Dystrophy (DMD)
Patient Advocacy - Duchenne@regenxbio.com
NCT05693142
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Part 1 - Key
Inclusion Criteria:
* The participant's legal guardian(s) is (are) willing and able to provide written, signed informed consent prior to any study-related procedures; and, where applicable, the minor participant has provided written or verbal assent according to local requirements.
* Is a male at least 4 years of age and less than 12 years of age at consent or 1 to \<4 years of age at the time of dosing and ≥ 10 kg at the time of screening.
* Must meet any of the following criteria:
* DMD gene mutation in exons 18 and above, and a clinical picture consistent with typical DMD with the exception of a participant (Cohort 1b) with DMD gene mutation in exons 12-17.
* Participant is able to walk 100 meters independently without assistive devices. Cohort 2c participant must be able to walk 10 meters independently without assistive devices. Cohort 1b participant must be able to walk with or without assistive devices.
* Participant is able to complete the TTSTAND per protocol-specific criteria.
* Participant has been on a stable dose of systemic glucocorticoids according to the standard of care for at least 12 weeks. Cohort 2c participants must be consistently on or off a stable dose of systemic glucocorticoids according to the standard of care for at least 12 weeks.
* Clinical laboratory test results, including hepatic and renal function, are within the normal range during screening, or if abnormal, are not clinically significant, in the opinion of the investigator.
* Documentation is provided at screening visit for participant's adherence to the local country's vaccination schedule. The parent(s) or legal guardian(s) must be willing to have their child receive a meningococcal vaccine, if not already vaccinated.
* Participant and parent(s)/legal guardian(s) are willing and able to comply with scheduled visits, study intervention administration plan, and study procedures.
Part 2 and 3 Inclusion Criteria:
* The participant's legal guardian(s) is (are) willing and able to provide written, signed informed consent prior to any study-related procedures; and, where applicable, the minor participant has provided written or verbal assent according to local requirements.
* DMD gene mutation with any mutation except for those with deletions or point mutations in exons 8, 9 and/or 10.
* Participant is able to complete the TTSTAND per protocol-specific criteria.
* Clinical laboratory test results, including hepatic and renal function, are within the normal range during screening, or if abnormal, are not clinically significant, in the opinion of the investigator.
* Documentation is provided at screening visit for participant's adherence to the local country's vaccination schedule. The parent(s) or legal guardian(s) must be willing to have their child receive a meningococcal vaccine, if not already vaccinated.
* Participant and parent(s)/legal guardian(s) are willing and able to comply with scheduled visits, study intervention administration plan, and study procedures.
* Is a male at least 1 year of age and ≥ 10 kg at the time of screening.
* Participants 1 to \<4 years of age must meet the following criteria:
* is able to walk 10 meters independently without assistive devices.
* must be consistently on or off a stable dose of systemic glucocorticoids according to the standard of care for at least 12 weeks.
* Participants 4 years and older must meet the following criteria:
* are able to walk 100 meters independently without assistive devices.
* have been on a stable dose of systemic glucocorticoids according to the standard of care for at least 12 weeks.
* have a NSAA total score ≥16.
Part 1 Exclusion Criteria:
* Participant has any condition that would contraindicate treatment with immunosuppression.
* Participant has received ataluren (a protein restoration therapy) or an exon-skipping therapy for the treatment of DMD within 6 months of study entry or is unable to refrain from taking ataluren or exon-skipping therapy for a duration of 5 years from the time of RGX-202 administration.
* Participant has received any investigational or commercial gene therapy product over his lifetime.
* Participant is currently taking any other investigational intervention (other than corticosteroids) or has taken any other investigational intervention (other than corticosteroids) within 3 months prior to the scheduled Day 1 intervention. If your corticosteroid is vamorolone, the participant will be asked to temporarily convert his daily dosing to prednisolone/prednisone during a short period of time around RGX-202 administration. He will be allowed to revert back to his baseline vamorolone regimen at the original per kilogram dose at which he entered the study and should remain on this for 24 months unless the investigator determines that this is not clinically indicated or possible.
* Participant has impaired cardiac function defined as a left ventricular ejection fraction of \< 55% on screening cardiac assessments (echocardiogram or MRI).
* Participant is not a good candidate for the study, in the opinion of the investigator.
Part 2 and 3 Exclusion Criteria:
* Participant has any condition that would contraindicate treatment with immunosuppression.
* Participant has received givinostat within 3 months of study entry or has received ataluren (a protein restoration therapy) or an exon-skipping therapy for the treatment of DMD within 6 months of study entry or is unable to refrain from taking ataluren or exon-skipping therapy for a duration of 5 years from the time of RGX-202 administration.
* Participant has received any investigational or commercial gene therapy product over his lifetime.
* Participant is currently taking any other investigational intervention (other than corticosteroids) or has taken any other investigational intervention (other than corticosteroids) within 3 months prior to the scheduled Day 1 intervention. If your corticosteroid is vamorolone, the participant will be asked to temporarily convert his daily dosing to prednisolone/prednisone during a short period of time around RGX-202 administration. He will be allowed to revert back to his baseline vamorolone regimen at the original per kilogram dose at which he entered the study and should remain on this for 24 months unless the investigator determines that this is not clinically indicated or possible.
* Participant has detectable AAV8 total binding antibodies in serum.
* Participant has impaired cardiac function defined as a left ventricular ejection fraction of \< 55% on screening cardiac assessments echocardiogram or MRI).
* Participant is not a good candidate for the study, in the opinion of the investigator. GENETIC: RGX-202
Duchenne Muscular Dystrophy
Gene therapy, DMD, Duchenne Muscular Dystrophy, Duchenne
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Show 16 locations
Study Locations
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| Location | Contacts |
|---|---|
| Alberta Children's Hospital Calgary, Alberta | Israt Yasmeen, MBT - (Israt.Yasmeen@ahs.ca) |
| Ann & Robert H. Lurie Children's Hospital of Chicago Chicago, Illinois | Nicole Geanous - (ngeanous@luriechildrens.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | Amber Evans - (evansa17@archildrens.org) |
| BC Children's Hospital Vancouver, British Columbia | Nela Martic - (NMartic3@cw.bc.ca) |
| Children's Hospital Colorado Aurora, Colorado | Michele Yang - (Michele.Yang@childrenscolorado.org) Hannah Kleiner - (Hannah.Kleiner@childrenscolorado.org) |
| Children's Hospital London Health Science Centre London, Ontario | Rhiannon Hicks - (rhiannon.hicks@lhsc.on.ca) |
| Children's Hospital Of Eastern Ontario Ottawa, Ontario | Laura Thompson - (lathompson@cheo.on.ca) |
| Children's Hospital of Richmond at Virginia Commonwealth University Richmond, Virginia | Falgun Patel - (Falgun.Patel@vcuhealth.org) |
| Children's Hospital of the King's Daughters Norfolk, Virginia | Erika Paradiso - (proud.research@chkd.org) |
| Cincinnati Children's Cincinnati, Ohio | Angela Edmondson - (Angela.Edmondson@cchmc.org) |
| Oregon Health & Science University Portland, Oregon | Beata Dyar - (dyar@ohsu.edu) |
| Rare Disease Research Atlanta, Georgia | Lily Goggans - (lily.goggans@rarediseaseresearch.com) Maureen Ikpeoha - (maureen.ikpeoha@rarediseaseresearch.com) |
| Stanford School of Medicine /Division of Neuromuscular Medicine Palo Alto, California | - (neuromuscularresearch@stanford.edu) |
| The University of Texas Southwestern Medical Center Dallas, Texas | Elaine Most - (elaine.most@utsouthwestern.edu) |
| University of Iowa Iowa City, Iowa | Laura Knosp - (laura-knosp@uiowa.edu) |
| University of Massachusetts Chan Medical School Worcester, Massachusetts | Tyler Mola - (tyler.mola@umassmed.edu) |
A Study Using Nivolumab, in Combination With Chemotherapy Drugs to Treat Nasopharyngeal Carcinoma (NPC)
ctrrecruit@vcu.edu
NCT06064097
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Inclusion Criteria:
* Patients must be ≤ 21 years of age at the time of study enrollment
* Newly diagnosed American Joint Committee on Cancer (AJCC) stage II-IV nasopharyngeal carcinoma (NPC)
* Patients must have had histologic verification of the malignancy at original diagnosis
* Although submission of tumor tissue for the molecular characterization initiative is not required for eligibility, it is strongly recommended
* Patients must have had histologic verification of the malignancy at original diagnosis
* Although submission of tumor tissue for the molecular characterization initiative is not required for eligibility, it is strongly recommended
* Patients must have a Lansky (for patients ≤ 16 years of age) or Karnofsky (for patients \> 16 years of age) performance status score of ≥ 60%
* Peripheral absolute neutrophil count (ANC) ≥ 1000/uL (within 7 days prior to start of protocol therapy)
* Platelet count ≥ 100,000/uL (transfusion independent) (within 7 days prior to start of protocol therapy)
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m\^2 or (within 7 days prior to start of protocol therapy)
* A serum creatinine based on age/sex (within 7 days prior to start of protocol therapy) Age: Maximum serum creatinine (mg/dL)
1 month to \< 6 months: 0.4 mg/dL (male); 0.4 mg/dL (female) 6 months to \< 1 year: 0.5 mg/dL (male); 0.5 mg/dL (female)
1 to \< 2 years: 0.6 mg/dL (male); 0.6 mg/dL (female) 2 to \< 6 years: 0.8 mg/dL (male); 0.8 mg/dL (female) 6 to \< 10 years 1 mg/dL (male); 1 mg/dL (female) 10 to \<13 years: 1.2 mg/dL (male); 1.2 mg/dL (female) 13 to \< 16 years: 1.5 mg/dL (male); 1.4 mg/dL (female)
≥ 16 years: 1.7 mg/dL (male); 1.4 mg/dL (female)
* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age, and (within 7 days prior to start of protocol therapy)
* Serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase \[ALT\]) ≤ 135 U/L\* (within 7 days prior to start of protocol therapy)
* Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L
* Shortening fraction of ≥ 27% by echocardiogram, or
* Ejection fraction of ≥ 50% by radionuclide angiogram
* No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \> 94% if there is clinical indication for determination
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months and T-cell count above the lower limit of normal are eligible for this trial
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Exclusion Criteria:
* Patients who received prior radiotherapy to the head or neck
* Patients who received prior chemotherapy or radiation for the treatment of any cancer in the last 3 years. These patients must also be in remission
* Patients with a diagnosis of immunodeficiency
* Patients with an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive agents). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
* Note: Patients with well-controlled asthma and no need for systemic steroids for the treatment of asthma in the last 12 months will not be excluded
* Patients with a condition requiring systemic treatment with either corticosteroids (\> 0.25 mg/kg (10 mg) daily prednisone equivalent) within 14 days or other immunosuppressive medications within 30 days of enrollment. Inhaled or topical steroids, and adrenal replacement steroid doses \> 0.25 mg/kg (10 mg) daily prednisone equivalent, are permitted in the absence of active autoimmune disease
* Patients with a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
* Patients with detectable viral load of human immunodeficiency virus (HIV), hepatitis B or hepatitis C, or active tuberculosis
* Patients who have undergone solid organ or allogeneic hematopoietic transplant at any time
* Due to risks of fetal and teratogenic adverse events as seen in animal studies, a negative pregnancy test must be obtained in females of childbearing potential, defined as females who are post-menarchal. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
* Females of childbearing potential that are sexually active must agree to either practice 2 medically accepted highly-effective methods of contraception at the same time or abstain from heterosexual intercourse from the time of signing the informed consent through 5 months after the last dose of nivolumab, 6 months after the last dose of gemcitabine, and 14 months after the last dose of cisplatin, whichever is longer
* Males of childbearing potential that are sexually active must agree to either practice a medically accepted highly-effective methods of contraception or abstain from heterosexual intercourse from the time of signing the informed consent through 3 months after the last dose of gemcitabine, and 11 months after the last dose of cisplatin, whichever is longer
* Lactating females are not eligible unless they have agreed not to breastfeed their infants starting with the first dose of study therapy through 5 months after the last dose of nivolumab
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, PROCEDURE: Chest Radiography, DRUG: Cisplatin, PROCEDURE: Computed Tomography, PROCEDURE: Echocardiography Test, OTHER: Electronic Health Record Review, OTHER: Fluciclovine F18, DRUG: Gemcitabine, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Multigated Acquisition Scan, BIOLOGICAL: Nivolumab, PROCEDURE: Positron Emission Tomography, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration, RADIATION: Radiation Therapy, PROCEDURE: X-Ray Imaging
Stage II Nasopharyngeal Carcinoma AJCC v8, Stage III Nasopharyngeal Carcinoma AJCC v8, Stage IV Nasopharyngeal Carcinoma AJCC v8
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Study Locations
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| Location | Contacts |
|---|---|
| Albany Medical Center Albany, New York | |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Arnold Palmer Hospital for Children Orlando, Florida | Site Public Contact - (Jennifer.spinelli@orlandohealth.com) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec | |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia | Site Public Contact - (Olivia.Floyd@choa.org) |
| Children's Hospital Colorado Aurora, Colorado | Site Public Contact - (josh.b.gordon@nsmtp.kp.org) |
| Children's Hospital New Orleans New Orleans, Louisiana | |
| Children's Hospital and Medical Center of Omaha Omaha, Nebraska | |
| Children's Hospital of Alabama Birmingham, Alabama | Site Public Contact - (oncologyresearch@peds.uab.edu) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Site Public Contact - (CancerTrials@email.chop.edu) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Site Public Contact - (jean.tersak@chp.edu) |
| Children's Hospital of San Antonio San Antonio, Texas | Site Public Contact - (bridget.medina@christushealth.org) |
| Children's Hospital of the King's Daughters Norfolk, Virginia | Site Public Contact - (CCBDCresearch@chkd.org) |
| Children's Mercy Hospitals and Clinics Kansas City, Missouri | Site Public Contact - (rryan@cmh.edu) |
| Children's National Medical Center Washington D.C., District of Columbia | Site Public Contact - (OncCRC_OnCall@childrensnational.org) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@cchmc.org) |
| Connecticut Children's Medical Center Hartford, Connecticut | |
| Cook Children's Medical Center Fort Worth, Texas | Site Public Contact - (CookChildrensResearch@cookchildrens.org) |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Dell Children's Medical Center of Central Texas Austin, Texas | Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org) |
| East Carolina University Greenville, North Carolina | Site Public Contact - (eubankss@ecu.edu) |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kaiser Permanente Downey Medical Center Downey, California | |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Loma Linda University Medical Center Loma Linda, California | |
| Lurie Children's Hospital-Chicago Chicago, Illinois | |
| M D Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| Mary Bridge Children's Hospital and Health Center Tacoma, Washington | Site Public Contact - (research@multicare.org) |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| Nationwide Children's Hospital Columbus, Ohio | Site Public Contact - (Melinda.Triplet@nationwidechildrens.org) |
| Nemours Children's Clinic-Jacksonville Jacksonville, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| Nemours Children's Hospital Orlando, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| Newark Beth Israel Medical Center Newark, New Jersey | Site Public Contact - (Christine.Kosmides@rwjbh.org) |
| Nicklaus Children's Hospital Miami, Florida | |
| Penn State Children's Hospital Hershey, Pennsylvania | |
| Phoenix Childrens Hospital Phoenix, Arizona | |
| Prisma Health Richland Hospital Columbia, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Rady Children's Hospital - San Diego San Diego, California | |
| Rainbow Babies and Childrens Hospital Cleveland, Ohio | |
| Riley Hospital for Children Indianapolis, Indiana | |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey | |
| Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida | Site Public Contact - (jennifer.manns@baycare.org) |
| Saint Jude Children's Research Hospital Memphis, Tennessee | Site Public Contact - (referralinfo@stjude.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Seattle Children's Hospital Seattle, Washington | |
| Starship Children's Hospital Auckland, | |
| The Children's Hospital at TriStar Centennial Nashville, Tennessee | |
| UCSF Benioff Children's Hospital Oakland Oakland, California | Site Public Contact - (cogbchoak@ucsf.edu) |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Florida Health Science Center - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Children's Hospital Madera, California | Site Public Contact - (Research@valleychildrens.org) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
ctrrecruit@vcu.edu
NCT05564377
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Inclusion Criteria:
* Patient must have measurable disease
* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-2 OR patient must have Lansky performance status of \>= 50% or Karnofsky performance status of \>= 50%
* Patient must be deemed potentially eligible for a ComboMATCH Treatment Trial as assessed by the enrolling provider
* All patients must have sequencing results available from a National Cancer Institute (NCI) credentialed Designated Laboratory (DL)
* Patients must have locally advanced or advanced histologically documented solid tumors requiring therapy and meet one of the following criteria:
* Patients must have progressed on at least one line of standard systemic therapy OR
* Patients whose disease has no standard treatment that has been shown to prolong overall survival
* Patient must meet one of the following requirements:
* Patients 18 years and older who have tumor amenable to minimal risk image-guided or direct vision biopsy and must be willing and able to undergo a tumor biopsy to obtain samples for research if the patient is to enroll in a ComboMATCH treatment trial OR
* Patients 18 years and older who do not have disease that is biopsiable at minimal risk to the patient must confirm availability of an archival tumor tissue specimen for submission for research if the patient enrolls to a ComboMATCH Treatment Trial. This tumor tissue must meet the following criteria:
* Tissue must have been collected within 12 months prior to registration to the EAY191 Registration Trial
* Patient must not have had a Response Evaluation Criteria in Solid Tumors (RECIST) response (complete response \[CR\] or partial response \[PR\]) to any intervening therapy after collection of the tissue
* Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be available OR
* Patients under 18 years old must confirm availability of an archival tumor tissue specimen for submission for research if patient enrolls to a ComboMATCH Treatment Trial. This tumor tissue must meet the following criteria:
* Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be available
* NOTE: See specific ComboMATCH Treatment Trial protocol for tissue collection and management instructions. Performance of the mandatory research biopsy or submission of pre-trial formalin-fixed paraffin-embedded (FFPE) and collection and submission of the blood specimens for the integrated studies will be performed under the consent authority of the specific treatment trial protocol to which the patient is registered. No procedures to collect specimens for research only are to be performed for patients registered to the EAY191 Registration Trial only
* NOTE: Each ComboMATCH Treatment Trial contains specific eligibility criteria. If patient is found to not be eligible for the assigned ComboMATCH Treatment Trial, indication of ineligibility will trigger re-evaluation and potential assignment to another Treatment Trial DRUG: Alpelisib, DRUG: Binimetinib, PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Scan, PROCEDURE: Computed Tomography, PROCEDURE: Echocardiography Test, DRUG: Fluorouracil, DRUG: Fulvestrant, DRUG: Ipatasertib, DRUG: Leucovorin, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Multigated Acquisition Scan, PROCEDURE: Mutation Carrier Screening, DRUG: Neratinib Maleate, DRUG: Nilotinib Hydrochloride Monohydrate, DRUG: Olaparib, DRUG: Oxaliplatin, DRUG: Paclitaxel, DRUG: Palbociclib, BIOLOGICAL: Panitumumab, PROCEDURE: Positron Emission Tomography, DRUG: Selumetinib Sulfate, DRUG: Sotorasib
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Locally Advanced Malignant Solid Neoplasm, Malignant Female Reproductive System Neoplasm, Metastatic HER2-Negative Breast Carcinoma, Metastatic Malignant Solid Neoplasm, Recurrent Endometrial Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Malignant Female Reproductive System Neoplasm, Recurrent Malignant Solid Neoplasm, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma, Unresectable HER2-Negative Breast Carcinoma, Unresectable Malignant Solid Neoplasm
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Show 458 locations
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| Location | Contacts |
|---|---|
| AMG Crystal Lake - Oncology Crystal Lake, Illinois | Site Public Contact - (advocateresearch@advocate.com) |
| AMG Libertyville - Oncology Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Adena Regional Medical Center Chillicothe, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Advocate Christ Medical Center Oak Lawn, Illinois | |
| Advocate Good Samaritan Hospital Downers Grove, Illinois | Site Public Contact - (Barbara.barhamand@advocatehealth.com) |
| Advocate Good Shepherd Hospital Barrington, Illinois | |
| Advocate Illinois Masonic Medical Center Chicago, Illinois | |
| Advocate Lutheran General Hospital Park Ridge, Illinois | |
| Advocate Sherman Hospital Elgin, Illinois | |
| Advocate South Suburban Hospital Hazel Crest, Illinois | |
| Alaska Women's Cancer Care Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Armes Family Cancer Center Findlay, Ohio | |
| Asplundh Cancer Pavilion Willow Grove, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Aultman Health Foundation Canton, Ohio | Site Public Contact - (ClinicalReserachDept@aultman.com) |
| Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora BayCare Medical Center Green Bay, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Grafton Grafton, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Kenosha South Kenosha, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Racine Racine, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Health Care Germantown Health Center Germantown, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Medical Center in Summit Summit, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Sinai Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora West Allis Medical Center West Allis, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri | |
| Baptist Cancer Center-Grenada Grenada, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Collierville Collierville, Tennessee | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Desoto Southaven, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Golden Triangle Columbus, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Memphis Memphis, Tennessee | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Oxford Oxford, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Union County New Albany, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baystate Medical Center Springfield, Massachusetts | Site Public Contact - (tamara.wrenn@baystatehealth.org) |
| Beacon Kalamazoo Kalamazoo, Michigan | |
| Beacon Kalamazoo Cancer Center Kalamazoo, Michigan | |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Beth Israel Deaconess Medical Center Boston, Massachusetts | |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Bronson Battle Creek Battle Creek, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Broward Health Medical Center Fort Lauderdale, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| Bryn Mawr Hospital Bryn Mawr, Pennsylvania | Site Public Contact - (turzoe@mlhs.org) |
| CTCA at Southeastern Regional Medical Center Newnan, Georgia | |
| CTCA at Western Regional Medical Center Goodyear, Arizona | |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care and Hematology-Fort Collins Fort Collins, Colorado | Site Public Contact - (ecog.rss@jimmy.harvard.edu) |
| Cancer Hematology Centers - Flint Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan | Site Public Contact - (connie.szczepanek@crcwm.org) |
| Capital Health Medical Center-Hopewell Pennington, New Jersey | |
| Carilion Roanoke Memorial Hospital Roanoke, Virginia | |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Case Western Reserve University Cleveland, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| Cedars Sinai Medical Center Los Angeles, California | |
| Centralia Oncology Clinic Centralia, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Centro Comprensivo de Cancer de UPR San Juan, | Site Public Contact - (ecog.rss@jimmy.harvard.edu) |
| Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Children's Hospital of Orange County Orange, California | Site Public Contact - (oncresearch@choc.org) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | |
| Cleveland Clinic Cancer Center/Fairview Hospital Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Columbus Oncology and Hematology Associates Dublin, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Columbus Oncology and Hematology Associates Inc Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Toms River, New Jersey | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Toms River, New Jersey | Site Public Contact - (Lennette.Gonzales@rwjbh.org) |
| Condell Memorial Hospital Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Contra Costa Regional Medical Center Martinez, California | |
| Corewell Health Beaumont Troy Hospital Troy, Michigan | |
| Corewell Health Children's Royal Oak, Michigan | |
| Corewell Health Dearborn Hospital Dearborn, Michigan | |
| Corewell Health Farmington Hills Hospital Farmington Hills, Michigan | |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan | |
| Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Reed City Hospital Reed City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health William Beaumont University Hospital Royal Oak, Michigan | |
| Covenant Medical Center-Lakeside Lubbock, Texas | |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dayton Physician LLC - Englewood Dayton, Ohio | |
| Dayton Physicians LLC-Atrium Franklin, Ohio | |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Delaware Health Center-Grady Cancer Center Delaware, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Doctors Cancer Center Manatí, | |
| Doctors Hospital Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Dublin Methodist Hospital Dublin, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Duke University Medical Center Durham, North Carolina | |
| Duke Women's Cancer Care Raleigh Raleigh, North Carolina | |
| Duluth Clinic Ashland Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| East Jefferson General Hospital Metairie, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| Edwards Comprehensive Cancer Center Huntington, West Virginia | Site Public Contact - (Christina.Cole@chhi.org) |
| Epic Care Cyberknife Center Walnut Creek, California | |
| Epic Care-Dublin Dublin, California | |
| Essentia Health - Deer River Clinic Deer River, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Cancer Center Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Hibbing Clinic Hibbing, Minnesota | |
| Essentia Health Sandstone Sandstone, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Virginia Clinic Virginia, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Fairfield Medical Center Lancaster, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Fairview Clinics and Surgery Center Maple Grove Maple Grove, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fox Chase Cancer Center Philadelphia, Pennsylvania | |
| Genesee Hematology Oncology PC Flint, Michigan | |
| Genesis Healthcare System Cancer Care Center Zanesville, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Genesys Hurley Cancer Institute Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Good Samaritan Hospital - Cincinnati Cincinnati, Ohio | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Grady Memorial Hospital Delaware, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Grant Medical Center Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Greater Dayton Cancer Center Kettering, Ohio | |
| Gulfport Memorial Hospital Gulfport, Mississippi | Site Public Contact - (emede1@lsuhsc.edu) |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | Site Public Contact - (cancerctr@gundersenhealth.org) |
| Guthrie Medical Group PC-Robert Packer Hospital Sayre, Pennsylvania | |
| Harold Alfond Center for Cancer Care Augusta, Maine | |
| Hawaii Cancer Care - Westridge ‘Aiea, Hawaii | Site Public Contact - (info@hawaiicancercare.com) |
| Hawaii Cancer Care Inc - Waterfront Plaza Honolulu, Hawaii | Site Public Contact - (i.webster@hawaiicancercare.com) |
| Heartland Regional Medical Center Saint Joseph, Missouri | Site Public Contact - (Trisha.England2@mymlc.com) |
| Helen F Graham Cancer Center Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Hendrick Medical Center Abilene, Texas | |
| Henry Ford Saint John Hospital - Macomb Medical Macomb, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Hillcrest Hospital Cancer Center Mayfield Heights, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Houston Methodist Hospital Houston, Texas | |
| Houston Methodist Saint John Hospital Nassau Bay, Texas | Site Public Contact - (ctsucontact@westat.com) |
| Houston Methodist Sugar Land Hospital Sugar Land, Texas | |
| Houston Methodist The Woodlands Hospital The Woodlands, Texas | Site Public Contact - (hmthewoodlands@houstonmethodist.org) |
| Houston Methodist West Hospital Houston, Texas | |
| Hurley Medical Center Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Huron Gastroenterology PC Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Illinois CancerCare - Washington Washington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Bloomington Bloomington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Canton Canton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Carthage Carthage, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Dixon Dixon, Illinois | |
| Illinois CancerCare-Eureka Eureka, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Galesburg Galesburg, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Kewanee Clinic Kewanee, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Macomb Macomb, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Ottawa Clinic Ottawa, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Pekin Pekin, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peoria Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peru Peru, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Princeton Princeton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Ingalls Memorial Hospital Harvey, Illinois | Site Public Contact - (clinicaltrials@ingalls.org) |
| Inova Fairfax Hospital Falls Church, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Inova Schar Cancer Institute Fairfax, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| John H Stroger Jr Hospital of Cook County Chicago, Illinois | |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Kettering Medical Center Newark, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Kingman Regional Medical Center Kingman, Arizona | Site Public Contact - (research@sncrf.org) |
| Knox Community Hospital Mount Vernon, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Lafayette Family Cancer Center-EMMC Brewer, Maine | |
| Lankenau Medical Center Wynnewood, Pennsylvania | Site Public Contact - (turzoe@mlhs.org) |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | Site Public Contact - (CancerTrials@nyulangone.org) |
| Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Lehigh Valley Hospital-Hazleton Hazleton, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Licking Memorial Hospital Newark, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Logan Health Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Loyola University Medical Center Maywood, Illinois | |
| Lyndon Baines Johnson General Hospital Houston, Texas | |
| M D Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MaineHealth Cancer Care and IV Therapy - South Portland South Portland, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Maine Medical Center- Scarborough Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Marshfield Medical Center - Minocqua Minocqua, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center - Weston Weston, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-Rice Lake Rice Lake, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Mayo Clinic Hospital in Arizona Phoenix, Arizona | |
| Mayo Clinic in Florida Jacksonville, Florida | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| Medical Center of the Rockies Loveland, Colorado | |
| Medical Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Memorial Hospital Marysville, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Memorial Hospital East Shiloh, Illinois | Site Public Contact - (dschwab@wustl.edu) |
| Memorial Hospital of South Bend South Bend, Indiana | |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Memorial Sloan Kettering Commack Commack, New York | |
| Memorial Sloan Kettering Monmouth Middletown, New Jersey | |
| Memorial Sloan Kettering Westchester Harrison, New York | |
| Mercy Cancer Center - Carmichael Carmichael, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Cancer Center - Elk Grove Elk Grove, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Cancer Center - Rocklin Rocklin, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Cancer Center - Sacramento Sacramento, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Health - Paducah Cancer Center Paducah, Kentucky | Site Public Contact - (BJWarner@mercy.com) |
| Mercy Health - Perrysburg Hospital Perrysburg, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mercy Health - Saint Anne Hospital Toledo, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mercy Hospital Coon Rapids, Minnesota | |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Mercy Hospital South St Louis, Missouri | Site Public Contact - (Danielle.Werle@mercy.net) |
| Mercy Hospital Springfield Springfield, Missouri | |
| Mercy Medical Center - Des Moines Des Moines, Iowa | Site Public Contact - (cancerresearch@mercydesmoines.org) |
| Mercy San Juan Medical Center Carmichael, California | Site Public Contact - (OncologyResearch@DignityHealth.org) |
| Mercyhealth Cancer Institute - Rockford Rockford, Illinois | Site Public Contact - (oncologyclinicaltrials@mhemail.org) |
| Mercyhealth Hospital and Cancer Center - Janesville Janesville, Wisconsin | Site Public Contact - (oncologyclinicaltrials@mhemail.org) |
| Methodist Willowbrook Hospital Houston, Texas | Site Public Contact - (ctsucontact@westat.com) |
| Miami Valley Cancer Care and Infusion Greenville, Ohio | |
| Miami Valley Hospital Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital North Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Miami Valley Hospital South Centerville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Michigan Healthcare Professionals Pontiac Pontiac, Michigan | Site Public Contact - (Emily.Crofts@trinity-health.org) |
| Midwestern Regional Medical Center Zion, Illinois | |
| Missouri Baptist Medical Center St Louis, Missouri | |
| Missouri Baptist Sullivan Hospital Sullivan, Missouri | |
| Monmouth Medical Center Long Branch, New Jersey | Site Public Contact - (mary.danish@rwjbh.org) |
| Monmouth Medical Center Southern Campus Lakewood, New Jersey | Site Public Contact - (mary.danish@rwjbh.org) |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Montefiore Medical Center-Einstein Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Montefiore Medical Center-Weiler Hospital The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Mount Carmel East Hospital Columbus, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mount Sinai Hospital New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Mount Sinai Hospital Medical Center Chicago, Illinois | Site Public Contact - (suhi@sinai.org) |
| Munson Medical Center Traverse City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| MyMichigan Medical Center Saginaw Saginaw, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| MyMichigan Medical Center Tawas Tawas City, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro, Arkansas | Site Public Contact - (Emily.Carvell@bmhcc.org) |
| NYU Langone Hospital - Long Island Mineola, New York | Site Public Contact - (cancertrials@nyulangone.org) |
| National Institutes of Health Clinical Center Bethesda, Maryland | |
| Nebraska Medicine-Bellevue Bellevue, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| Nebraska Medicine-Village Pointe Omaha, Nebraska | |
| North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington | Site Public Contact - (Memorial-ClinicalTrials@yvmh.org) |
| NorthShore University HealthSystem-Evanston Hospital Evanston, Illinois | |
| NorthShore University HealthSystem-Glenbrook Hospital Glenview, Illinois | |
| NorthShore University HealthSystem-Highland Park Hospital Highland Park, Illinois | |
| Northwestern Medicine Cancer Center Delnor Geneva, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Glenview Outpatient Center Glenview, Illinois | |
| Northwestern Medicine Grayslake Outpatient Center Grayslake, Illinois | |
| Northwestern Medicine Lake Forest Hospital Lake Forest, Illinois | Site Public Contact - (cancertrials@northwestern.edu) |
| Northwestern Medicine Orland Park Orland Park, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| OSF Saint Francis Hospital and Medical Group Escanaba, Michigan | Site Public Contact - (WI_research_admin@hshs.org) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| OhioHealth Mansfield Hospital Mansfield, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| OhioHealth Marion General Hospital Marion, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa | |
| Oncology Hematology Associates of Saginaw Valley PC Saginaw, Michigan | |
| OptumCare Cancer Care at Charleston Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Fort Apache Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Seven Hills Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| PCR Oncology Arroyo Grande, California | Site Public Contact - (research@sncrf.org) |
| PROncology San Juan, | Site Public Contact - (info@PRoncology.com) |
| Pali Momi Medical Center ‘Aiea, Hawaii | |
| Paoli Memorial Hospital Paoli, Pennsylvania | Site Public Contact - (turzoe@mlhs.org) |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Parkland Health Center - Farmington Farmington, Missouri | |
| Pennsylvania Hospital Philadelphia, Pennsylvania | Site Public Contact - (PennCancerTrials@careboxhealth.com) |
| Phelps Health Delbert Day Cancer Institute Rolla, Missouri | Site Public Contact - (research@phelpshealth.org) |
| Pluta Cancer Center Rochester, New York | Site Public Contact - (ecog.rss@jimmy.harvard.edu) |
| Pocono Medical Center East Stroudsburg, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Poudre Valley Hospital Fort Collins, Colorado | |
| Premier Blood and Cancer Center Dayton, Ohio | |
| Presbyterian Intercommunity Hospital Whittier, California | |
| Prisma Health Cancer Institute - Butternut Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Easley Easley, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Eastside Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Faris Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Greer Greer, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Seneca Seneca, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Spartanburg Boiling Springs, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Richland Hospital Columbia, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| ProHealth D N Greenwald Center Mukwonago, Wisconsin | Site Public Contact - (research.institute@phci.org) |
| ProHealth Oconomowoc Memorial Hospital Oconomowoc, Wisconsin | |
| Providence Newberg Medical Center Newberg, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Portland Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Regional Cancer System-Lacey Lacey, Washington | Site Public Contact - (deidre.dillon@providence.org) |
| Providence Saint Mary Regional Cancer Center Walla Walla, Washington | Site Public Contact - (Cheryl.Dodd@providence.org) |
| Providence Saint Vincent Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Willamette Falls Medical Center Oregon City, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Puerto Rico Hematology Oncology Group Bayamón, | |
| Queen's Cancer Cenrer - POB I Honolulu, Hawaii | |
| Queen's Cancer Center - Kuakini Honolulu, Hawaii | |
| Queen's Medical Center Honolulu, Hawaii | |
| Rapid City Regional Hospital Rapid City, South Dakota | Site Public Contact - (research@monument.health) |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Reid Health Richmond, Indiana | |
| Renown Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Riddle Memorial Hospital Media, Pennsylvania | Site Public Contact - (turzoe@mlhs.org) |
| Riverside Methodist Hospital Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Robert Wood Johnson University Hospital Somerset Somerville, New Jersey | Site Public Contact - (Siby.Varughese@rwjbh.org) |
| Roger Williams Medical Center Providence, Rhode Island | Site Public Contact - (fdallesandro@chartercare.org) |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| Saint Alphonsus Cancer Care Center-Boise Boise, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Ann's Hospital Westerville, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Saint Barnabas Medical Center Livingston, New Jersey | Site Public Contact - (joanne.loeb@rwjbh.org) |
| Saint Elizabeth Youngstown Hospital Youngstown, Ohio | |
| Saint Francis Cancer Center Greenville, South Carolina | Site Public Contact - (Heather_Rich@bshsi.org) |
| Saint Francis Hospital Greenville, South Carolina | Site Public Contact - (Heather_Rich@bshsi.org) |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Saint John's Cancer Institute Santa Monica, California | |
| Saint John's Hospital - Healtheast Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint Joseph Hospital - Orange Orange, California | |
| Saint Joseph Hospital East Lexington, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Meridian Meridian, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Nampa Nampa, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Twin Falls Twin Falls, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Hospital Chesterfield, Missouri | |
| Saint Mary's Oncology/Hematology Associates of West Branch West Branch, Michigan | |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sheboygan Sheboygan, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri | |
| Sanford Bismarck Medical Center Bismarck, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicTrialsSF@sanfordhealth.org) |
| Sanford Joe Lueken Cancer Center Bemidji, Minnesota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Roger Maris Cancer Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Sharp Memorial Hospital San Diego, California | Site Public Contact - (cathy.wood@sharp.com) |
| Sheboygan Physicians Group Sheboygan, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Sidney Kimmel Cancer Center Washington Township Sewell, New Jersey | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Siteman Cancer Center at Christian Hospital St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at West County Hospital Creve Coeur, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center-South County St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Southeastern Medical Oncology Center-Clinton Clinton, North Carolina | Site Public Contact - (jfields@cancersmoc.com) |
| Southeastern Medical Oncology Center-Goldsboro Goldsboro, North Carolina | Site Public Contact - (jfields@cancersmoc.com) |
| Southeastern Medical Oncology Center-Jacksonville Jacksonville, North Carolina | Site Public Contact - (jfields@cancersmoc.com) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Southern Ohio Medical Center Portsmouth, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| Springfield Regional Cancer Center Springfield, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Springfield Regional Medical Center Springfield, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Stanford Cancer Institute Palo Alto Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| State University of New York Upstate Medical University Syracuse, New York | |
| Straub Clinic and Hospital Honolulu, Hawaii | |
| Strecker Cancer Center-Belpre Belpre, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Summerlin Hospital Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Swedish Cancer Institute-Edmonds Edmonds, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Cancer Institute-Issaquah Issaquah, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Medical Center-First Hill Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| The Angeles Clinic and Research Institute - West Los Angeles Office Los Angeles, California | Site Public Contact - (ecog.rss@jimmy.harvard.edu) |
| The Mark H Zangmeister Center Columbus, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| The Queen's Medical Center - West Oahu ‘Ewa Beach, Hawaii | Site Public Contact - (rohta@queens.org) |
| ThedaCare Cancer Care - Berlin Berlin, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Cancer Care - New London New London, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Cancer Care - Oshkosh Oshkosh, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Cancer Care - Shawano Shawano, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Cancer Care - Waupaca Waupaca, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Regional Cancer Center Appleton, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Regional Medical Center - Appleton Appleton, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| ThedaCare Regional Medical Center - Neenah Neenah, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Toledo Clinic Cancer Centers-Toledo Toledo, Ohio | |
| Trinity Health Grand Rapids Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Medical Center - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Medical Center - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Muskegon Hospital Muskegon, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Tufts Medical Center Boston, Massachusetts | Site Public Contact - (ContactUsCancerCenter@TuftsMedicalCenter.org) |
| UC Comprehensive Cancer Center at Silver Cross New Lenox, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| UC San Diego Health System - Encinitas Encinitas, California | |
| UC San Diego Medical Center - Hillcrest San Diego, California | Site Public Contact - (rhabbaba@health.ucsd.edu) |
| UC San Diego Moores Cancer Center La Jolla, California | Site Public Contact - (cancercto@ucsd.edu) |
| UCHealth Greeley Hospital Greeley, Colorado | Site Public Contact - (ecog.rss@jimmy.harvard.edu) |
| UCHealth University of Colorado Hospital Aurora, Colorado | |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UH Seidman Cancer Center at Lake Health Mentor Campus Mentor, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| UH Seidman Cancer Center at Southwest General Hospital Middleburg Heights, Ohio | |
| UH Seidman Cancer Center at UH Avon Health Center Avon, Ohio | |
| UHHS-Chagrin Highlands Medical Center Beachwood, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa | |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Waukee Clinic Waukee, Iowa | |
| UM Sylvester Comprehensive Cancer Center at Aventura Aventura, Florida | |
| UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables, Florida | |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach, Florida | |
| UM Sylvester Comprehensive Cancer Center at Kendall Miami, Florida | |
| UM Sylvester Comprehensive Cancer Center at Plantation Plantation, Florida | |
| UPMC Altoona Altoona, Pennsylvania | Site Public Contact - (ecog.rss@jimmy.harvard.edu) |
| UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg, Pennsylvania | |
| UPMC Hillman Cancer Center - Monroeville Monroeville, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Hillman Cancer Center Erie Erie, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion Mechanicsburg, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Western Maryland Cumberland, Maryland | |
| UPMC-Magee Womens Hospital Pittsburgh, Pennsylvania | |
| UPMC-Passavant Hospital Pittsburgh, Pennsylvania | |
| UW Cancer Center at ProHealth Care Waukesha, Wisconsin | Site Public Contact - (Chanda.miller@phci.org) |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| University Medical Center New Orleans New Orleans, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| University of Alabama at Birmingham Cancer Center Birmingham, Alabama | Site Public Contact - (tmyrick@uab.edu) |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Chicago Medicine-Orland Park Orland Park, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Florida Health Science Center - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| University of Hawaii Cancer Center Honolulu, Hawaii | |
| University of Illinois Chicago, Illinois | |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Maryland/Greenebaum Cancer Center Baltimore, Maryland | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Michigan - Brighton Center for Specialty Care Brighton, Michigan | |
| University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan | Site Public Contact - (slusserb@med.umich.edu) |
| University of Michigan Health - Sparrow Lansing Lansing, Michigan | Site Public Contact - (harsha.trivedi@umhsparrow.org) |
| University of Michigan Health - West Wyoming, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania | |
| University of South Alabama Mitchell Cancer Institute Mobile, Alabama | Site Public Contact - (pfrancisco@usouthal.edu) |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| Upper Valley Medical Center Troy, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| VA Palo Alto Health Care System Palo Alto, California | |
| VCU Community Memorial Health Center South Hill, Virginia | Site Public Contact - (nemer.elmouallem@vcuhealth.org) |
| VCU Massey Cancer Center at Stony Point Richmond, Virginia | Site Public Contact - (ctoclinops@vcu.edu) |
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| Valley Medical Center Renton, Washington | Site Public Contact - (research@valleymed.org) |
| Vanderbilt Breast Center at One Hundred Oaks Nashville, Tennessee | |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Vince Lombardi Cancer Clinic - Oshkosh Oshkosh, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Sheboygan Sheboygan, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Two Rivers Two Rivers, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Virginia Cancer Institute Richmond, Virginia | Site Public Contact - (smoore@vacancer.com) |
| Walter Reed National Military Medical Center Bethesda, Maryland | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
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| West Virginia University Charleston Division Charleston, West Virginia | |
| West Virginia University Healthcare Morgantown, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Women and Infants Hospital Providence, Rhode Island | |
| Woodland Cancer Care Center Michigan City, Indiana | |
| Woodland Memorial Hospital Woodland, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Zangmeister Center Grove City Grove City, Ohio |
Phase 2/3 Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1- Mediated Proteinuric Kidney Disease (AMPLITUDE)
Medical Information - medicalinfo@vrtx.com
NCT05312879
Show full eligibility criteria
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Key
Inclusion Criteria:
* APOL1 genotype of G1/G1, G2/G2, or G1/G2
* Proteinuric kidney disease
Key Exclusion Criteria:
* Solid organ or bone marrow transplant
* Uncontrolled hypertension
* History of diabetes mellitus
* Known underlying cause of kidney disease including but not limited to sickle cell disease
Other protocol defined Inclusion/Exclusion criteria apply. DRUG: VX-147, DRUG: Placebo
Proteinuric Kidney Disease
APOL1-mediated kidney disease (AMKD)
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Show 314 locations
Study Locations
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| Location | Contacts |
|---|---|
| A. Alfred Taubman Health Care Center - Nephrology Clinic at Taubman Center Ann Arbor, Michigan | |
| AA Medical Research Center Flint, Michigan | |
| AMR-Miami Coral Gables, Florida | |
| AURA Nord Saint-Ouen, | |
| Advanced Clinical Research of Atlanta Atlanta, Georgia | |
| Alabama Kidney Research Alabaster, Alabama | |
| Ambroise Paré Hospital Paris, | |
| American Clinical Trials LLC - Acworth Acworth, Georgia | |
| American Clinical Trials LLC - Douglasville Douglasville, Georgia | |
| Amicis Research Center - Balboa Granada Hills, California | |
| Amsterdam UMC - Amsterdam Public Health Research Institute Amsterdam, | |
| Ann & Robert H. Lurie Children's Hospital of Chicago - Nephrology Chicago, Illinois | |
| Arlington Nephrology Arlington, Texas | |
| Atlanta VA Healthcare System Decatur, Georgia | |
| Augusta University Medical College of Georgia - Adult Sickle Cell Clinic Augusta, Georgia | |
| Barnes-Jewish Center for Outpatient Health St Louis, Missouri | |
| Barnum Medical Research - Bienville St Natchitoches, Louisiana | |
| Bay Pines Foundation Bay Pines, Florida | |
| Baylor Scott and White Research Institute - Nephrology Dallas, Texas | |
| Beth Israel Deaconess Medical Center - Nephrology Boston, Massachusetts | |
| Bicetre Hospital Le Kremlin-Bicêtre, | |
| Bioluminux Clinical Research New Jersey Hamilton, New Jersey | |
| Boston Medical Center Boston, Massachusetts | |
| Brookview Hills Research Associates Winston-Salem, North Carolina | |
| CHI St. Vincent Heart Clinic Arkansas- Cardiology and Medicine Clinic - Little Rock Little Rock, Arkansas | |
| CHU Dupuytren 2 - Néphrologie, dialyse, transplantations Limoges, | |
| CHU de Guadeloupe Pointe à Pitre, | |
| CNS Healthcare - Memphis Memphis, Tennessee | |
| CSB Group of Nephrology Brazil Salvador, | |
| CTR Oakwater, LLC Orlando, Florida | |
| CUH - Sheridan Pavilion - Three Cooper Plaza Camden, New Jersey | |
| Cardiology, P.C. Birmingham, Alabama | |
| Carolina Nephrology, PA Spartanburg, South Carolina | |
| Cedars-Sinai Medical Center Los Angeles, California | |
| Center for Advanced Kidney Research Saint Clair Shores, Michigan | |
| Center for Specialized Medicine - Nephrology St Louis, Missouri | |
| Centro Cardiovascular Aristides Sotomayor Santa Lucía SAS IPS Cartagena, | |
| Centro de Pesquisa Clinica Professor Salomao Kelner Recife, | |
| Centro de Pesquisa Clinica do Coracao Aracaju, | |
| Children's Hospital of Alabama Birmingham, Alabama | |
| Children's Hospital of Pittsburgh - Nephrology Pittsburgh, Pennsylvania | |
| Children's National Hospital - Nephrology Washington D.C., District of Columbia | |
| Cincinnati VA Medical Center Cincinnati, Ohio | |
| Cleveland Clinic - Main Campus Cleveland, Ohio | |
| Clincept - Veterans Pkwy. Columbus, Georgia | |
| Clindove Research LLC Brooklyn, New York | |
| Clinica de La Costa S.A.S Atlántico, | |
| Clinical & Translational Science Unit (CTSU) - Nephrology Kansas City, Kansas | |
| Clinical Research Strategies - Romano North Main Office Houston, Texas | |
| Clinical Research of Brandon, LLC Brandon, Florida | |
| Cmip-Centro Mineiro de Pesquisa Ltda Juiz de Fora, | |
| Coastal Medical Research Brunswick, Georgia | |
| Columbia Nephrology Associates, PA Columbia, South Carolina | |
| Comlexo Hospitalar Universitário Professor Edgard Santos Salvador, | |
| Cook Children's Medical Center Fort Worth, Texas | |
| Cordova Research Institute Miami, Florida | |
| DaVita Kidney Care - Las Vegas Las Vegas, Nevada | |
| Dallas Nephrology Associates - Dallas Landry Office Dallas, Texas | |
| Dallas Renal Group - Liberty Dallas Dialysis Center Dallas, Texas | |
| Dallas Renal Group - Mansfield Arlington, Texas | |
| Dallas Renal Group- Dallas Dallas, Texas | |
| Davita Clinical Research - El Paso El Paso, Texas | |
| Delray Physician Care Center Delray Beach, Florida | |
| Dom Vicente Scherer Hospital Porto Alegre, | |
| Duke University Hospital - Children's Health Center Durham, North Carolina | |
| Eastern Nephrology Associates - Greenville Office Greenville, North Carolina | |
| Eastern Nephrology Associates - Jacksonville Office Jacksonville, North Carolina | |
| Eastern Nephrology Associates - Kinston Office Kinston, North Carolina | |
| Eastern Nephrology Associates - New Bern Office New Bern, North Carolina | |
| Eastern Nephrology Associates - Wilmington Office Wilmington, North Carolina | |
| Eastside Clinical Research Associates Los Angeles, California | |
| Edward Hines Jr VA Hospital Hines, Illinois | |
| Elixia Pines Hollywood, Florida | |
| Elixia Tampa Tampa, Florida | |
| EmVenio Research - Chicago Chicago, Illinois | |
| EmVenio Research - Mobile Unit - Birmingham Birmingham, Alabama | |
| Emory Childrens Center - Nephrology Atlanta, Georgia | |
| Emory School of Medicine - Renal Division Atlanta, Georgia | |
| Epsom and St Helier University Hospitals NHS Trust Carshalton, | |
| Essential Concepts Research Solutions Palos Hills, Illinois | |
| FDI Clinical Research San Juan, | |
| Faculdade de Medicina de Botucatu - CKD and Hypertension Department Botucatu, | |
| Faculdade de Medicina de Botucatu - Kidney Transplantation Department Botucatu, | |
| Federal University of Goiás (UFG) Goiânia, | |
| Fides Clinical Research Atlanta, Georgia | |
| Frenova-Southwest Houston Houston, Texas | |
| Fundacion Hospitalaria San Vicente de Paul Medellín, | |
| Fundación Valle Del Lili Santiago de Cali, | |
| Fundação Faculdade Regional de Medicina de São José do Rio Preto Sao Jose Rio Preto, | |
| FutureMeds Birmingham Birmingham, | |
| G.V. (Sonny) Montgomery VAMC Jackson, Mississippi | |
| GCM Medical Group, PSC San Juan, | |
| Galileo Medical Research Ltda Juiz de Fora, | |
| General Nephrology Clinic - New York City New York, New York | |
| Genesis Clinical Research Tampa, Florida | |
| Georgia Nephrology - Decatur Decatur, Georgia | |
| Georgia Nephrology - Lawrenceville - Billing Office Lawrenceville, Georgia | |
| Great Ormond Street Hospital For Children London, | |
| Greater Hartford Nephrology Bloomfield, Connecticut | |
| Grossman School of Medicine New York, New York | |
| Guy's Hospital - Endocrinology London, | |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Heart Center Research LLC Huntsville, Alabama | |
| Helen Diller Medical Center at Parnassus Heights San Francisco, California | |
| Henry Ford Health System - Nephrology Detroit, Michigan | |
| Hopital Henri Mondor - Nephrology Créteil, | |
| Hopital Necker Enfants Malades - Nephrology Paris, | |
| Hopital Tenon Paris, | |
| Hopital de la Conception Marseille, Provence-Alpes-Côte d'Azur Region | |
| Horizon Research Group - Coral Gables Coral Gables, Florida | |
| Hospital Ana Nery/SESAB Salvador, | |
| Hospital Clinic de Barcelona - Nephrology Barcelona, | |
| Hospital Curry Cabral - Serviço de Nefrologia Lisbon, | |
| Hospital Nord Michallon - Nephrology Grenoble, | |
| Hospital Nove de Julho - Nephrology São Paulo, | |
| Hospital São Lucas Rio de Janeiro, | |
| Hospital Universitari Vall d´Hebron - Servicio de Pediatria Barcelona, | |
| Hospital Universitario 12 de Octubre - Nephrology Madrid, | |
| Hospital Universitario Virgen Macarena Seville, Andalusia | |
| Hospital das Clínicas da Faculdade de Medicina - Laboratório de Nefrologia Celular, Genética e Molecular São Paulo, | |
| Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto Monte Alegre, | |
| Hospital de Clínicas de Porto Alegre - Nephrology Porto Alegre, | |
| Hospital do Rim - Fundação Oswaldo Ramos São Paulo, | |
| Houston Medical Research Institute, LLC Houston, Texas | |
| Hôpital de Rangueil Toulouse, | |
| ICM - Instituto do Coração de Marília Marília/SP, | |
| IPECC - Instituto de Pesquisa Clinica de Campinas Campinas, | |
| IU School of Medicine - Nephrology Indianapolis, Indiana | |
| Icahn School of Medicine at Mount Sinai - Nephrology New York, New York | |
| Infigo Clinical Research Sanford, Florida | |
| Inova Clinical Trials and Research Center Tyrone, Georgia | |
| Instituto Pro-Renal Curitiba, | |
| Instituto de Ensino e Pesquisa Clinica do Ceara Fortaleza, | |
| InterMed Consultants - Edina Clinic Edina, Minnesota | |
| Irmandade Da Santa Casa De Misericordia De Sao Paulo São Paulo, | |
| James J. Peters VA Medical Center The Bronx, New York | |
| Javara Inc./Privia Medical Group - Annapolis, MD Annapolis, Maryland | |
| Javara Inc./Privia Medical Group - Fayetteville, GA Fayetteville, Georgia | |
| Javara Inc./Privia Medical Group - Savannah, GA Savannah, Georgia | |
| Javara Inc./Privia Medical Group - Silver Spring, MD - Columbia Pike Silver Spring, Maryland | |
| Jefferson Einstein Philadelphia Hospital - Nephrology Philadelphia, Pennsylvania | |
| Jefferson Health - 33 South 9th Street Philadelphia, Pennsylvania | |
| Jersey Shore University Medical Center Neptune City, New Jersey | |
| Kaiser Permanente Georgia Atlanta, Georgia | |
| Kaiser Permanente Los Angeles Medical Center Los Angeles, California | |
| Kaiser Permanente Sacramento Medical Center Sacramento, California | |
| Kidney Care Center of North Valley Granada Hills, California | |
| Kidney Care and Transplant Services of New England - West Springfield West Springfield, Massachusetts | |
| Kidney Medical Associates, PLLC The Bronx, New York | |
| Kidney Specialists of N Houston, PLLC Shenandoah, Texas | |
| Kidney and Hypertension Center Victorville, California | |
| King's College Hospital - Pulmonology London, | |
| Kings County Hospital Brooklyn, New York | |
| Komfo Anokye Teaching Hospital - Nephrology Kumasi, | |
| LCMC Health Metairie, Louisiana | |
| Lagos State University Teaching Hospital Ikeja, | |
| Lagos University Teaching Hospital Surulere, Lagos | |
| Le Bonheur Children's Hospital - Outpatient Clinic Memphis, Tennessee | |
| Leicester General Hospital Leicester, | |
| Lewis Katz School of Medicine at Temple University - Section of Nephrology Philadelphia, Pennsylvania | |
| Lifespan Clinical Research Center East Providence, Rhode Island | |
| Louis Stokes Cleveland VA Medical Center Cleveland, Ohio | |
| Louisiana Clinical and Translational Science (LA CaTS) Center New Orleans, Louisiana | |
| Louisiana State University Health Shreveport Shreveport, Louisiana | |
| MD Medical Research Oxon Hill, Maryland | |
| Manchester Royal Infirmary - Endocrinology Manchester, | |
| McGuire Research Institute, Inc. (151) Richmond, Virginia | |
| MedBio Trials Miami, Florida | |
| Medical College of Wisconsin - Pulmonology Milwaukee, Wisconsin | |
| Medical University of South Carolina - Pulmonology Charleston, South Carolina | |
| Mediservis del Tolima IPS S.A.S. Ibagué, | |
| Metrolina Nephrology Associates - Freedom Dr Charlotte, North Carolina | |
| Mid and South Essex Hospitals NHS Trust Basildon, | |
| Mid-Atlantic Permanente Research Institute Gaithersburg, Maryland | |
| Milwaukee Nephrologists - Wauwatosa Wauwatosa, Wisconsin | |
| Minneapolis VA Healthcare System Minneapolis, Minnesota | |
| Monroe Research, LLC West Monroe, Louisiana | |
| Montefiore Einstein - Albert Einstein College of Medicine The Bronx, New York | |
| Montefiore Einstein Hospital - Moses Campus The Bronx, New York | |
| Morehouse School of Medicine, Grady Memorial Hospital Atlanta, Georgia | |
| NANI Research LLC - Evergreen Park IL Evergreen Park, Illinois | |
| NANI Research LLC - Fort Wayne IN Fort Wayne, Indiana | |
| NTKDA Lewisville Lewisville, Texas | |
| NYC Health + Hospital/Harlem New York, New York | |
| Nashville General Hospital - Meharry Medical College - Nephrology Nashville, Tennessee | |
| Nashville VA Medical Center Nashville, Tennessee | |
| Nephrology & Hypertension Associates, PC Middlebury, Connecticut | |
| Nephrology Associates Fairhope, Alabama | |
| Nephrology Associates of Tidewater, LTD Virginia Beach, Virginia | |
| Nephrology Associates, P.C. - Columbus Columbus, Mississippi | |
| Nephrology Clinical Trials Center Nashville, Tennessee | |
| Nephrology Consultants, LLC Huntsville, Alabama | |
| Nephrology Physicians, LLC Mishawaka, Indiana | |
| Nephrology and Hypertension Associates - Tupelo Tupelo, Mississippi | |
| Nephrotex Research Group Dallas, Texas | |
| Nevada Kidney Disease and Hypertension Centers Las Vegas, Nevada | |
| New Mexico VA Healthcare System Albuquerque, New Mexico | |
| New York Presbyterian Queens Flushing, New York | |
| Nigerian Institute of Medical Research Lagos, | |
| North Carolina Nephrology P.A. - Cary Cary, North Carolina | |
| North Florida/South Georgia Veterans Health System Gainesville, Florida | |
| Northwest Louisiana Nephrology, LLC Shreveport, Louisiana | |
| Northwestern Medical Group Chicago, Illinois | |
| Nottingham University Hospitals - Children's Clinical Research Facility - Pulmonology Nottingham, | |
| Nova Clinical Research, LLC - Bradenton - 59th St Bradenton, Florida | |
| Ochsner Medical Center - New Orleans New Orleans, Louisiana | |
| Ohio State University - Wexner Medical Center - Nephrology Clinical Trials Unit Columbus, Ohio | |
| Olive Branch Family Medical Center Olive Branch, Mississippi | |
| Omega Research Orlando, LLC - Mercy Dr Orlando, Florida | |
| PUC Trials - Unidade Epicenter Curitiba, | |
| Patient First Clinical Trials Lutherville, Maryland | |
| Pharmacorp Clinical Trials, Inc Charleston, South Carolina | |
| Phoenix Children's Hospital, Inc. - Nephrology Phoenix, Arizona | |
| Praxis Pesquisa Medica Santo André, São Paulo | |
| Premier Clinical Research Overland Park, Kansas | |
| Prime Clinical Research - Mansfield - Regency Parkway Mansfield, Texas | |
| Prime Clinical Research Inc - Lewisville Lewisville, Texas | |
| Prime Health and Wellness Fayette, Mississippi | |
| Prolato Clinical Research Center - Kirby Dr Houston, Texas | |
| Promotora Medica Las Americas S.A. - Clinica Las Americas Medellín, | |
| QUEST Research Institute Farmington Hills, Michigan | |
| Queen Elizabeth Hospital Birmingham Birmingham, | |
| Qway Research Hialeah, Florida | |
| Randomize Now - College Park College Park, Georgia | |
| Recherche GCP Research Montreal, | |
| Reina Sofia University Hospital - Nephrology Córdoba, | |
| Renal Associates Columbus, Georgia | |
| Renal Associates of Alabama, LLC Montgomery, Alabama | |
| Renal Associates of Baton Rouge Baton Rouge, Louisiana | |
| Renal Medicine Associates Albuquerque, New Mexico | |
| Renal Research of Montgomery County, PLLC The Woodlands, Texas | |
| Renal and Transplant Associates of New England, PC Springfield, Massachusetts | |
| Ronald Ralph MD PA Houston, Texas | |
| Rophe Adult and Pediatric Medicine Union City, Georgia | |
| Royal Free Hospital - Nephrology London, | |
| Rutgers Doctors Office Center Newark, New Jersey | |
| SKY Integrative Medical Center Ridgeland, Mississippi | |
| SUNY Downstate Health Sciences University Brooklyn, New York | |
| San Antonio Kidney Disease Center Physicians Group - Medical Center San Antonio, Texas | |
| San Antonio Kidney Disease Center Physicians Group - Westover Hills San Antonio, Texas | |
| Santa Casa de Misericordia de Belo Horizonte Belo Horizonte, | |
| Scott Research, Inc. Laurelton, New York | |
| Shands Hospital - Nephrology Gainesville, Florida | |
| Solano & Terront Servicios Medicos SAS - Unidad Integral de Endocrinologia - UNIENDO Bogotá, | |
| South Florida Nephrology Research Coral Springs, Florida | |
| South Florida Research Miami Springs, Florida | |
| South Florida Research Institute Lauderdale Lakes, Florida | |
| Southeast Kidney Associates East Point, Georgia | |
| Southeast Renal Research Institute Chattanooga, Tennessee | |
| Southwest Family Medicine Associates (SFMA) - Dallas Dallas, Texas | |
| Sparrow Clinical Research Institute Lansing, Michigan | |
| St George's Hospital London - Nephrology London, | |
| St Pancras Clinical Research London, | |
| St. Clair Nephrology Research Roseville, Michigan | |
| St. Louis Children's Hospital - Nephrology St Louis, Missouri | |
| St. Louis Heart and Vascular, P.C. St Louis, Missouri | |
| Synexus Clinical Research - Atlanta (DRS) Atlanta, Georgia | |
| Synexus Clinical Research - Chicago (DRS) Chicago, Illinois | |
| Synexus Clinical Research - Glasgow (DRS) Bellshill, | |
| Synexus Clinical Research - Midlands (DRS) Birmingham, | |
| Synexus Clinical Research - NW Consortium Manchester (DRS) Manchester, | |
| Synexus Clinical Research - New York (DRS) New York, New York | |
| Synexus Clinical Research - Orlando Orlando, Florida | |
| Texas Tech University Health Sciences Center Lubbock, Texas | |
| The Bank Hospital Cantonments, | |
| The George Washington University - GW Medical Faculty Associates Washington D.C., District of Columbia | |
| The Johns Hopkins University - Johns Hopkins Hospital - Nephrology Baltimore, Maryland | |
| The Kirklin Clinic - Nephrology Birmingham, Alabama | |
| The Medical Research Group - Saint Agnes Medical Center Fresno, California | |
| The Rogosin Kidney Center New York, New York | |
| The Royal London Hospital - Nephrology London, | |
| Tidewater Kidney Specialists - Church St. Norfolk, Virginia | |
| Total Research Group, LLC Miami, Florida | |
| Tranquil Clinical Research Webster, Texas | |
| Tufts Medical Center Boston, Massachusetts | |
| UAMS Medical Center - Pulmonology Little Rock, Arkansas | |
| UC - DCI McMillan Research Unit Cincinnati, Ohio | |
| UCI Center for Clinical Research Irvine, California | |
| UCLA Division of Nephrology Los Angeles, California | |
| UCLA Lundquist Institute at Harbor-UCLA Medical Center Torrance, California | |
| UChicago Medicine - Comer Children's Hospital Chicago, Illinois | |
| UF Health Cardiovascular Center - Jacksonville Jacksonville, Florida | |
| UH Cleveland Medical Center - Nephrology Cleveland, Ohio | |
| UMMC Grenada Hospital Grenada, Mississippi | |
| UNC Clinical and Translational Research Center Chapel Hill, North Carolina | |
| UTSW Medical Center - Nephrology Dallas, Texas | |
| UVA Health - Nephrology Clinical Research Center Charlottesville, Virginia | |
| UW Medical Center - Montlake - Nephrology Seattle, Washington | |
| Unidade Local de Saude Amadora/Sintra, E.P.E. Amadora, | |
| Unidade Local de Saúde de Loures-Odivelas, E.P.E. Loures, | |
| Unidade Local de Saúde de Santa Maria, E.P.E. - Nephrology Lisbon, | |
| Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg - Pulmonology Leuven, | |
| Universite Catholique de Louvain - Pulmonology Woluwe-Saint-Lambert, Brussels Capital | |
| University College Hospital Ibadan, | |
| University Medical Center - New Orleans - Nephrology New Orleans, Louisiana | |
| University of Ghana Medical School - Nephrology Accra, | |
| University of Iowa Health Care Medical Center- Nephrology Iowa City, Iowa | |
| University of Maryland Medical Center - General Clinical Research Center Baltimore, Maryland | |
| University of Nigeria Teaching Hospital Enugu, | |
| University of Puerto Rico Rio Piedras, | |
| University of Texas Health Science Center - Nephrology San Antonio, Texas | |
| Université Paris-Descartes / Hôpital Européen Georges Pompidou Paris, | |
| VA New York Harbor Healthcare System New York, New York | |
| Velocity Clinical Research - Hallandale Beach Hallandale, Florida | |
| Veterans Affairs Medical Center - Washington D.C Washington D.C., District of Columbia | |
| Virginia Commonwealth University - Division of Nephrology Richmond, Virginia | |
| Walter Cantídio University Hospital Fortaleza, | |
| Whittier Street Health Center Roxbury, Massachusetts | |
| Women's College Hospital Toronto, Ontario | |
| Wythenshawe Hospital - Medicines Evaluation Unit Manchester, | |
| Yale University - Yale Nephrology Clinical Research Clinic New Haven, Connecticut | |
| York Clinical Research, LLC Norfolk, Virginia | |
| Zenos Clinical Research Dallas, Texas | |
| Zucker School of Medicine Great Neck, New York |
Streamlined Treatment of Pulmonary Exacerbations in Pediatrics (STOP PEDS RCT)
Erika Enright - eenright@uw.edu
NCT06654752
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Inclusion Criteria:
• Age
• For main cohort and non-HEMT cohort: age 6 to \<19 years
• For preschool cohort: age 3 to \<6 years
• Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:
• sweat chloride ≥ 60 mEq/liter
• two disease-causing variants in the cystic fibrosis transmembrane conductive regulator (CFTR) gene
• Written informed consent (and assent when applicable) obtained from participant or participant's legal representative and ability of participant to comply with the requirements of the study
• Highly Effective Modulator Therapy
• For main cohort and preschool cohort: Taking ETI or ivacaftor for at least 3 months at enrollment
• For non-HEMT cohort: not eligible for HEMT based on CFTR genotype or eligible but not taking for at least 3 months and no plans to start HEMT in the next year, and also not taking tezacaftor-ivacaftor or lumacaftor-ivacaftor for at least 3 months
• For main cohort and non-HEMT cohort: able to perform acceptable and reproducible spirometry
• For main cohort and non-HEMT cohort: ppFEV1 ≥ 50% predicted at enrollment based on the Global lung Initiative (GLI) reference equations
• Ability to receive text messages and access the internet
Exclusion Criteria:
• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the individual or the quality of the data
• Receiving an acute course of oral or IV antibiotics at the time of enrollment or within the 14 days prior to enrollment. Individuals may be re-screened ≥21 days after completion of antibiotics if they are at their baseline state of health, per self-report
• Treatment with systemic corticosteroids at enrollment or within the 14 days prior to enrollment. Individuals may be re- screened ≥21 days after completion of systemic corticosteroids if they are at their clinical baseline, per self-report
• History of solid organ transplant
• History of positive culture for Mycobacterium abscessus in the 12 months prior to enrollment
• Treatment with antibiotics for any non-tuberculous mycobacteria (NTM) at enrollment
• Three or more IV antibiotic-treated PEx in the 12 months prior to enrollment
• Treatment with chronic oral antibiotics other than azithromycin at enrollment
• Treatment with systemic corticosteroids for allergic bronchopulmonary aspergillosis (ABPA) in the 12 months prior to enrollment
OTHER: Immediate Oral Antibiotics, OTHER: Tailored Treatment: Oral Antibiotics only if Additional Treatment needed
Cystic Fibrosis
cystic fibrosis, oral antibiotics, pulmonary exacerbation, pediatric
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Show 33 locations
Study Locations
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| Location | Contacts |
|---|---|
| Ann & Robert H. Lurie Children's Hospital of Chicago & Northwestern University Chicago, Illinois | Mariah Flowers - (maflowers@luriechildrens.org) |
| Boston Children's Hospital & Harvard University Boston, Massachusetts | Ethan Ito - (ethan.ito@childrens.harvard.edu) |
| British Columbia Children's Hospital Vancouver, British Columbia | Madison Weir - (Madison.Weir@bcchr.ca) |
| Children's Healthcare of Atlanta & Emory University Atlanta, Georgia | Joy Dangerfield - (jdanger@emory.edu) |
| Children's Hospital of Colorado Aurora, Colorado | Mary Cross - (Mary.Cross@childrenscolorado.org) |
| Children's Hospital of Los Angeles & Anton Yelchin Cystic Fibrosis Clinic Los Angeles, California | Jared Lopez, BA - (jalopez@chla.usc.edu) |
| Children's Hospital of Philadelphia & University of Pennsylvania Philadelphia, Pennsylvania | Erin Donnelly - (donnellye4@email.chop.edu) |
| Children's Hospital of Pittsburgh of UPMC & University of Pittsburgh Medical Center Pittsburgh, Pennsylvania | Adrienne DeRicco, RN - (adrienne.dericco2@upmc.edu) |
| Children's Hospitals and Clinics of Minnesota Minneapolis, Minnesota | Briana Escobar, CRC - (Briana.Escobar@childrensmn.org) |
| Children's Mercy Hospital Kansas City, Missouri | Jana Lomonte - (jblomonte@cmh.edu) |
| Children's Wisconsin & Medical College of Wisconsin Milwaukee, Wisconsin | Laura Roth, CCRC - (lroth@mcw.edu) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Sharon Kadon, RN, BSN, CPN - (sharon.kadon@cchmc.org) |
| Johns Hopkins Hospital, Johns Hopkins University Baltimore, Maryland | Jamelia Maynard - (jmaynar8@jhmi.edu) |
| Medical University of South Carolina Charleston, South Carolina | Audra Wiser - (wisera@musc.edu) |
| Oregon Health & Science University Portland, Oregon | Pierce Nusbaum - (nusbaum@ohsu.edu) |
| Rady Children's Hospital at University of California San Diego San Diego, California | Lisa Ramos, CRC - (lramosvallejo@health.ucsd.edu) |
| Riley Hospital for Children & Indiana University Indianapolis, Indiana | Misty Thompson - (misthomp@iu.edu) Lisa Bendy - (lbendy@iu.edu) |
| Seattle Children's Hospital Seattle, Washington | Sharon McNamara - (sharon.mcnamara@seattlechildrens.org) |
| St. Louis Children's Hospital & Washington University School of Medicine St Louis, Missouri | Emily Schulte, RN, BSN - (e.burns@wustl.edu) |
| Stanford University Palo Alto, California | Tina Conti, BSRC, RRT, RRT-NPS, C-NPT - (tconti@stanford.edu) |
| Texas Children's Hospital & Baylor College of Medicine Houston, Texas | Pavel Tuekam - (OrnellaPavel.TuekamMeko@bcm.edu) |
| The Children's Hospital Alabama & University of Alabama at Birmingham Birmingham, Alabama | Ashlyn Hastings - (aehastings@uabmc.edu) |
| The Hospital for Sick Children & Toronto Canada CF Centre Pediatrics Toronto, Ontario | Sheryl Hewko - (sheryl.hewko@sickkids.ca) |
| The Minnesota Cystic Fibrosis Center & University of Minnesota Minneapolis, Minnesota | Alyssa Perry - (ahperry@umn.edu) |
| Tucson Cystic Fibrosis Center Tucson, Arizona | Elizabeth (Lisa) Ryan - (elizabethryan@arizona.edu) |
| University of Iowa Iowa City, Iowa | Mary Teresi - (mary-teresi@uiowa.edu) |
| University of Michigan Health System Ann Arbor, Michigan | Dawn Kruse - (dmkruse@med.umich.edu) |
| University of North Carolina at Chapel Hill Chapel Hill, North Carolina | Caroline Flowers, CRC - (caroline_flowers@med.unc.edu) |
| University of Rochester Medical Center Strong Memorial Rochester, New York | Barbara Johnson, RN - (Barbara_johnson@urmc.rochester.edu) Karen McCarthy - (karen_mccarthy@urmc.rochester.edu) |
| University of Texas Southwestern & Children's Health Dallas, Texas | Lindsay Allen, CRC - (Lindsay.Allen@utsouthwestern.edu) |
| University of Wisconsin Madison, Wisconsin | Melanie Nelson, BS, RRT, CCRC - (mmnelson@medicine.wisc.edu) |
| Vermont Children's Hospital & University of Vermont Medical Center Burlington, Vermont | Vanessa Marascio - (Vanessa.Marascio@uvmhealth.org) |
| Virginia Commonwealth University Richmond, Virginia | Akilah Pierre-Louis, CRC - (Akilah.PierreLouis1@vcuhealth.org) |
A Study of Emapalumab for Pediatric Aplastic Anemia
Andromachi Scaradavou, MD - ScaradaA@mskcc.org
NCT06430788
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Inclusion Criteria:
* Patients undergoing workup for suspected newly diagnosed sAA:
* Patients with severe cytopenias and a hypocellular marrow concerning for sAA
* Patients that meet the definition for suspected sAA (Camitta Criteria) as follows:
Marrow Cellularity: \<25%, or 25-50% with \<30% residual hematopoietic cells Peripheral cytopenias (at least 2 of 3) Absolute neutrophil count (ANC): \<500 x 10\^9/L Platelets: \<20 x 10\^9/L Absolute Reticulocyte Count: \<60 x 10\^9/L
* Patients that do not have evidence of leukemia or MDS
* Patients \< 25 years of age at time of diagnosis
* Able to tolerate emapalumab and IST (with standard institutional organ function criteria)
Exclusion Criteria:
* Uncontrolled infection at presentation.
* Patients who have undergone previous treatment for sAA.
* Patients with known inherited bone marrow failure
* Patient who has completed a full workup for sAA including having results back from telomere testing, DEB and genetics (when applicable), as well as having an appropriate willing and available donor and would otherwise be admitted for HSCT within 2 weeks of enrolling on the trial
* Patients with leukemia or MDS
* Patient or parent or guardian unable to give informed consent or unable to comply with the treatment protocol including research tests. BIOLOGICAL: Emapalumab
Aplastic Anemia, Cytopenia, Hypocellular Marrow
pediatric aplastic anemia, aplastic anemia, cytopenia, hypocellular marrow, Emapalumab, Memorial Sloan Kettering Cancer Center, 23-278
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Show 6 locations
Study Locations
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| Location | Contacts |
|---|---|
| Children's Hospital of Philadelphia (Data Collection AND Specimen Analysis) Philadelphia, Pennsylvania | |
| Children's Hospital of Wisconsin (Data Collection Only) Milwaukee, Wisconsin | |
| Cincinnati Children's Hospital Medical Center (Data collection only) Cincinnati, Ohio | Anthony Sabulski, MD - (anthony.sabulski@cchmc.org) |
| Medical College of Wisconsin (Data Collection AND Data Analysis) Milwaukee, Wisconsin | |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York, New York | |
| Virginia Commonwealth University (Data Collection Only ) Richmond, Virginia |
A Study of Treatment for Medulloblastoma Using Sodium Thiosulfate to Reduce Hearing Loss
ctrrecruit@vcu.edu
NCT05382338
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Inclusion Criteria:
* PRE-ENROLLMENT: Patients must be ≥ 4 years and ≤ 21 years of age at the time of enrollment
* PRE-ENROLLMENT: Patient is suspected to have newly-diagnosed medulloblastoma by institutional diagnosis
* Please note: Patients with a pending result of CSF cytology tests are eligible for NCI-2014-02057 (APEC14B1-Central Nervous System \[CNS\]) and CNS/Medulloblastoma Pre Enrollment Eligibility Screening
* PRE-ENROLLMENT: The patient and/or their parents or legal guardians must have signed informed consent for APEC14B1 Part A - Eligibility Screening and consent for the Molecular Characterization Initiative (MCI)
* PRE-ENROLLMENT: The required specimens are projected to be submitted under APEC14B1-CNS as soon as possible, preferably within 5 days of definitive surgery
* PRE-ENROLLMENT: All patients must have rapid central pathology review under APEC14B1-CNS prior to study enrollment on ACNS2031 step 1 in order to avoid discordant diagnoses and to verify diagnosis criterion for treatment on ACNS2031.
* Note: Patients with a pending result of CSF cytology tests are eligible for the rapid central pathology screening review. Confirmation of CSF negativity is needed for enrollment on the ACNS2031 protocol
* PRE-ENROLLMENT: All patients must have rapid central molecular screening review under APEC14B1-CNS prior to study enrollment on ACNS2031 step 1, in order to avoid discordant diagnoses and to verify diagnosis criterion for treatment on ACNS2031
* PRE-ENROLLMENT: All patients who have histopathology confirmed must have rapid central imaging screening review under APEC14B1 prior to study enrollment on ACNS2031 step 1
* Note: Patients must not have metastatic disease on cranial or spinal MRI. Patients with \> 1.5 cm\^2 residual tumor after initial surgical resection may undergo a second surgical resection prior to subsequent therapy to render them eligible for this study. The day of the second resection to remove residual tumor will be regarded as the day of definitive surgery (Day 0) and must be within a month (31 days) of the initial resection
* PRE-ENROLLMENT: All patients who have histopathology confirmed must have rapid central audiology review under APEC14B1-CNS prior to study enrollment on ACNS2031 step 1
* Patients must be \>= 4 years and =\< 21 years of age at the time of enrollment
* Patients must be newly diagnosed and have eligibility confirmed by rapid central pathology and molecular screening reviews performed on APEC14B1 and via the Molecular Characterization Initiative
* Average-risk cohort
* Clinico-pathologic criteria:
* M0 disease
* No diffuse anaplastic histology AND
* Molecular criteria:
* SHH, p53wt, GLI2 normal, MYCN normal, no chromosome 14q loss
* Group 3, MYC normal, no isochromosome 17q
* Group 4, no chromosome 11 loss
* Low-risk features cohort
* Clinico-pathologic criteria:
* M0 disease
* No diffuse anaplastic histology AND
* Molecular criteria:
* Group 4, chromosome 11 loss
* Patients must have negative lumbar CSF cytology
* Note: CSF cytology for staging should be performed no sooner than 14 days post operatively to avoid false positive CSF. Ideally, CSF should be obtained between day 14 and day 21 to allow for final staging status before enrollment onto the study. Patients with positive CSF cytology obtained 0 to 14 days after surgery should have cytology repeated to determine eligibility and final CSF status. Patients with negative CSF cytology from lumbar puncture obtained 0 to 14 days after surgery do not need cytology repeated. Patients with negative CSF cytology from lumbar puncture obtained prior to surgery do not need cytology repeated post-operatively
* Patients must have eligibility confirmed by Rapid Central Imaging Review performed on APEC14B1. Patients must have =\< 1.5 cm\^2 cross-sectional area of residual tumor. Whole brain MRI with and without gadolinium and spine MRI with gadolinium must be performed
* Patients must weigh \> 10 kg
* Patients must be enrolled, and protocol therapy must be projected to begin, no later than 31 days after definitive diagnostic surgery (day 0)
* Peripheral absolute neutrophil count (ANC) \>= 1000/uL (within 7 days prior to enrollment)
* Platelet count \>= 100,000/uL (transfusion independent) (within 7 days prior to enrollment)
* Hemoglobin \>= 8.0 g/dL (may receive red blood cell count \[RBC\] transfusions) (within 7 days prior to enrollment)
* A serum creatinine (within 7 days prior to enrollment) based on age/sex as follows:
* 4 to \< 6 years (age); 0.8 mg/dL (male) 0.8 mg/dL (female)
* 6 to \< 10 years (age); 1 mg/dL (male) 1 mg/dL (female)
* 10 to \< 13 years (age); 1.2 mg/dL (male) 1.2 mg/dL (female)
* 13 to \< 16 years (age); 1.5 mg/dL (male) 1.4 mg/dL (female)
* \>= 16 years (age); 1.7 mg/dL (male) 1.4 mg/dL (female) OR a 24 hour urine Creatinine clearance \>= 70 mL/min/1.73 m\^2 (within 7 days prior to enrollment) OR a glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 (within 7 days prior to enrollment). GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard)
* Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)
* Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 135 U/L (within 7 days prior to enrollment)
* Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L
* Central nervous system function defined as:
* Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled
* Patients must not be in status epilepticus, a coma or assisted ventilation at the time of study enrollment
* Auditory function defined as:
* Patients must have normal hearing (defined as International Society of Pediatric Oncology \[SIOP\] grade 0) in at least one ear confirmed by rapid central audiology review performed on APEC14B1 prior to enrollment
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
* Patients with metastatic disease by either MRI evaluation or lumbar CSF cytology are not eligible. Patients who are unable to undergo a lumbar puncture for assessment of CSF cytology are ineligible
* Patients must not have received any prior radiation therapy or chemotherapy (tumor-directed therapy) other than surgical intervention and/or corticosteroids
* Patients must not have any known hypersensitivity to STS, sulfates/sulfites, or other thiol agents (e.g., amifostine, n-acetylcysteine, MESNA, and captopril)
* Pregnancy and Breastfeeding:
* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential
* Lactating females who plan to breastfeed their infants
* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation PROCEDURE: Audiometric Test, PROCEDURE: Auditory Brainstem Response, PROCEDURE: Biospecimen Collection, DRUG: Cisplatin, DRUG: Cyclophosphamide, DRUG: Lomustine, PROCEDURE: Magnetic Resonance Imaging, OTHER: Quality-of-Life Assessment, RADIATION: Radiation Therapy, DRUG: Sodium Thiosulfate, OTHER: Survey Administration, DRUG: Vincristine
Childhood Medulloblastoma
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Show 91 locations
Study Locations
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| Location | Contacts |
|---|---|
| Albany Medical Center Albany, New York | |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Arnold Palmer Hospital for Children Orlando, Florida | Site Public Contact - (Jennifer.spinelli@orlandohealth.com) |
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| C S Mott Children's Hospital Ann Arbor, Michigan | |
| Cardinal Glennon Children's Medical Center St Louis, Missouri | |
| Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec | Site Public Contact - (yvan.samson@umontreal.ca) |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia | Site Public Contact - (Olivia.Floyd@choa.org) |
| Children's Hospital Colorado Aurora, Colorado | Site Public Contact - (josh.b.gordon@nsmtp.kp.org) |
| Children's Hospital Los Angeles Los Angeles, California | |
| Children's Hospital Medical Center Of Akron Akron, Ohio | |
| Children's Hospital New Orleans New Orleans, Louisiana | |
| Children's Hospital and Medical Center of Omaha Omaha, Nebraska | |
| Children's Hospital of Alabama Birmingham, Alabama | |
| Children's Hospital of Michigan Detroit, Michigan | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Orange County Orange, California | Site Public Contact - (oncresearch@choc.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Site Public Contact - (CancerTrials@email.chop.edu) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Site Public Contact - (jean.tersak@chp.edu) |
| Children's Hospital of San Antonio San Antonio, Texas | Site Public Contact - (bridget.medina@christushealth.org) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | Site Public Contact - (MACCCTO@mcw.edu) |
| Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota | Site Public Contact - (pauline.mitby@childrensmn.org) |
| Children's Mercy Hospitals and Clinics Kansas City, Missouri | Site Public Contact - (rryan@cmh.edu) |
| Children's National Medical Center Washington D.C., District of Columbia | Site Public Contact - (OncCRC_OnCall@childrensnational.org) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@cchmc.org) |
| Corewell Health Children's Royal Oak, Michigan | |
| Dayton Children's Hospital Dayton, Ohio | |
| Dell Children's Medical Center of Central Texas Austin, Texas | Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org) |
| East Carolina University Greenville, North Carolina | Site Public Contact - (eubankss@ecu.edu) |
| El Paso Children's Hospital El Paso, Texas | Site Public Contact - (ranjan.bista@ttuhsc.edu) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Golisano Children's Hospital of Southwest Florida Fort Myers, Florida | Site Public Contact - (molly.arnstrom@leehealth.org) |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Legacy Emanuel Children's Hospital Portland, Oregon | |
| Loma Linda University Medical Center Loma Linda, California | |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | |
| Mary Bridge Children's Hospital and Health Center Tacoma, Washington | Site Public Contact - (research@multicare.org) |
| Massachusetts General Hospital Cancer Center Boston, Massachusetts | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| Medical City Dallas Hospital Dallas, Texas | |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (OHR@mhs.net) |
| Miller Children's and Women's Hospital Long Beach Long Beach, California | |
| Montefiore Medical Center - Moses Campus The Bronx, New York | |
| Nationwide Children's Hospital Columbus, Ohio | Site Public Contact - (Melinda.Triplet@nationwidechildrens.org) |
| Nemours Children's Clinic-Jacksonville Jacksonville, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| Nemours Children's Hospital Orlando, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| New York Medical College Valhalla, New York | |
| Newark Beth Israel Medical Center Newark, New Jersey | Site Public Contact - (Christine.Kosmides@rwjbh.org) |
| Nicklaus Children's Hospital Miami, Florida | |
| Norton Children's Hospital Louisville, Kentucky | Site Public Contact - (CancerResource@nortonhealthcare.org) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Phoenix Childrens Hospital Phoenix, Arizona | |
| Prisma Health Richland Hospital Columbia, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington | Site Public Contact - (HopeBeginsHere@providence.org) |
| Rady Children's Hospital - San Diego San Diego, California | |
| Rainbow Babies and Childrens Hospital Cleveland, Ohio | |
| Rhode Island Hospital Providence, Rhode Island | |
| Riley Hospital for Children Indianapolis, Indiana | |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida | Site Public Contact - (jennifer.manns@baycare.org) |
| Saint Joseph's Regional Medical Center Paterson, New Jersey | Site Public Contact - (HallL@sjhmc.org) |
| Saint Jude Midwest Affiliate Peoria, Illinois | |
| Saint Peter's University Hospital New Brunswick, New Jersey | Site Public Contact - (kcovert@saintpetersuh.com) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Seattle Children's Hospital Seattle, Washington | |
| Sinai Hospital of Baltimore Baltimore, Maryland | |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| State University of New York Upstate Medical University Syracuse, New York | |
| Stony Brook University Medical Center Stony Brook, New York | |
| The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York | |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| USA Health Strada Patient Care Center Mobile, Alabama | |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University of Illinois Chicago, Illinois | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Texas Health Science Center at San Antonio San Antonio, Texas | Site Public Contact - (phoresearchoffice@uthscsa.edu) |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Children's Hospital Madera, California | Site Public Contact - (Research@valleychildrens.org) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment (ELFINITY)
Ipsen Clinical Study Enquiries - clinical.trials@ipsen.com
NCT06447168
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Inclusion Criteria:
* Participant has provided written informed consent and agrees to comply with the study protocol.
* Participant with PBC diagnosis.
* Participant for whom the treating physician has decided to start or participants who are currently receiving treatment with commercialized elafibranor.
* If a participant has a caregiver who agrees to complete the caregiver questionnaires, an informed consent should be collected from the caregiver before any data is collected.
Exclusion Criteria:
* Participant is currently participating or, plans to participate in an investigational drug study or medical device study containing active substance.
* Participant with known hypersensitivity to the product or to any of its excipients.
* Participant with mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain. Primary Biliary Cholangitis
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Show 46 locations
Study Locations
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| Location | Contacts |
|---|---|
| (G.I.R.I) GI Research Institute Foundation Vancouver, | |
| Aberdeen Royal Infirmary NHS Grampian Grampian Health Board Aberdeen, | |
| Baylor College of Medicine - Advanced Liver Therapies Houston, Texas | |
| Belfast Health and Social Care Trust - Royal Victoria Hospital Belfast, | |
| Beth Israel Deaconess Medical Center, Liver Research Center Boston, Massachusetts | |
| Bon Secours Richmond Community Hospital LLC. d/b/a Bon Secours Liver Institute of Richmond Richmond, Virginia | |
| Bradford Royal Infirmary - Bradford Teaching Hospitals NHS Foundation Bradford, | |
| Cedars-Sinai Medical Center Los Angeles, California | |
| Charité Universitätsmedizin Berlin Berlin, | |
| Clemenceau Medical Center Hospital Dubai, | |
| Cleveland Clinic Foundation Cleveland, Ohio | |
| DRK Kliniken Berlin Mitte Berlin, | |
| Gastro health & Nutrition Seattle, Washington | |
| Gastroenterologsiche Studiengesellschaft Herne Herne, | |
| General Hospital of Athens Laiko Athens, | |
| Hospital of the Merciful Brothers Trier Trier, | |
| Hull Royal Infirmary - Hull University Teaching Hospitals NHS Trust Hull, | |
| Intermountain Medical Center Murray, Utah | |
| Ippokratio General Hospital of Thessaloniki Thessaloniki, | |
| John Radcliffe Hospital - Oxford University Hospitals NHS Foundation Trust Oxford, | |
| King's College Hospital NHS Foundation Trust London, | |
| Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt, | |
| Liver Center of Texas Dallas, Texas | |
| Medical University Innsbruck Innsbruck, | |
| Medical University of South Carolina (MUSC) Charleston, South Carolina | |
| Mediclinic Airport Road Hospital Dubai, | |
| Medizinische Universitaetsklinik Graz Graz, | |
| Northwell Health Inc, Center for Liver Disease and Transplantation Manhasset, New York | |
| Queen Elizabeth Hospital Birmingham - University Hospitals Birmingham NHS Foundation Trust Birmingham, | |
| Queen's Medical Centre - Nottingham University Hospitals NHS Trust Nottingham, | |
| Schiff Center for Liver Diseases - University of Miami Miami, Florida | |
| Sheikh Shakhbout Medical City Dubai, | |
| South Denver Gastroenterology,P.C. Englewood, Colorado | |
| Southern California Research Center Coronado, California | |
| Studiengesellschaft BSF Halle, | |
| The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital Newcastle, | |
| Universitaet des Saarlandes Homburg, | |
| Universitaetsklinikum Leipzig Leipzig, | |
| University General Hospital of Patras Pátrai, | |
| University Hospital of Heraklion Heraklion - Crete, | |
| University of Calgary Calgary, Alberta | |
| University of California Davis Medical Center Sacramento, California | |
| Velocity Clinical Research Katy, Texas | |
| Virginia Commonwealth University Medical Center - West Hospital Richmond, Virginia | |
| Virtua Center for Liver Disease - Cherry Hill Cherry Hill, New Jersey | |
| Yale University School of Medicine New Haven, Connecticut |
ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD)
Clinical Trials Contact Center - ML-004-002@Maplightrx.com
NCT05081245
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Inclusion Criteria:
* Age 12 to 45 at screening
* Has a designated care/study partner who can reliably report on symptoms
* Has a diagnosis of Autism Spectrum Disorder (ASD)
* Has a body mass index (BMI) 18 through 34 kg/m², inclusive
* Full scale IQ (or equivalent) ≥55 score, with adequate verbal fluency, as determined by the Principal Investigator.
* Psychoactive medications and adjunctive therapies are stable for 4 weeks prior to screening
* Must be able to swallow study medication
Exclusion Criteria:
* Has Rett syndrome or Child Disintegrative Disorder
* Has participated in any other study and received any other investigational medication (other than COVID-19 vaccination) or device within 60 days prior to screening
* History of epilepsy without current adequate control, or any seizure in the 6 months preceding screening
* History of suicidal ideation or behavior in the past 12 months, or a positive response to C-SSRS questions 4 and/or 5
* Systolic blood pressure ≥140 mmHg (if adult) or \>135 mmHg (if adolescent), or diastolic blood pressure ≥90 (if adult) or \>85 mmHg (if adolescent), or a clinical history of uncontrolled or severe hypertension
* If female, is pregnant or lactating DRUG: ML-004 (IR)/(ER) tablet, DRUG: ML-004 Placebo
Autism Spectrum Disorder
ASD, Autism, Autism Spectrum Disorder, Social Communication
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Study Locations
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| Location | Contacts |
|---|---|
| AMR-Baber Research Inc Naperville, Illinois | |
| APG Research, LLC Orlando, Florida | |
| Abba Medical Group Miami, Florida | |
| BioBehavioral Research of Austin Austin, Texas | |
| Brain and Mind Centre Camperdown, New South Wales | |
| Cedar Clinical Research Draper, Utah | |
| Center for Autism and the Developing Brain, New York State Psychiatric Institute White Plains, New York | |
| Children's Health Queensland Hospital and Health Service South Brisbane, Queensland | |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | |
| Children's National Health System - The Children's Research Institute (CRI) Washington D.C., District of Columbia | |
| Cortica San Rafael, California | |
| Cortica Healthcare Glendale, California | |
| Family Psychiatry of The Woodlands The Woodlands, Texas | |
| Flinders Medical Centre Bedford Park, South Australia | |
| Harmonex Neuroscience Research Dothan, Alabama | |
| Hassman Research Institute Berlin, New Jersey | |
| Holland Bloorview Kids Rehabilitation Hospital Toronto, Ontario | |
| Jersey Shore University Medical Center Neptune City, New Jersey | |
| Lawson Health Research Institute/ London Health Sciences Centre London, Ontario | |
| Lurie Center for Autism Massachusetts General Hospital Lexington, Massachusetts | |
| Massachusetts General Hospital Boston, Massachusetts | |
| Mater Research South Brisbane, Queensland | |
| NRC Research Institute Orange, California | |
| Nathan Kline Institute for Psychiatric Research Orangeburg, New York | |
| Neurobehavioral Medicine Group Bloomfield Hills, Michigan | |
| OCT Research ULC (dba Okanagan Clinical Trials) Kelowna, British Columbia | |
| Ohio State University Nisonger Center Columbus, Ohio | |
| Pacific Clinical Research Management Group Upland, California | |
| Red Oak Psychiatry Associates, PA Houston, Texas | |
| Richmond Behavioral Associates Staten Island, New York | |
| Road Runner Research, Ltd. San Antonio, Texas | |
| Seattle Children's Autism Center Seattle, Washington | |
| Southwest Autism Research & Resource Center, Clinical Research Phoenix, Arizona | |
| Suburban Research Associates Media, Pennsylvania | |
| The Royal Children's Hospital, Murdoch Children's Research Institute Parkville, Victoria | |
| Thompson Autism and Neurodevelopmental Center Orange, California | |
| University of California, San Francisco San Francisco, California | |
| University of Missouri, Thompson Center for Autism & Neurodevelopmental Disorders Columbia, Missouri | |
| University of South Florida Psychiatry and Behavioral Neurosciences Tampa, Florida | |
| Virginia Commonwealth University Richmond, Virginia | |
| Yale Child Study Center New Haven, Connecticut |
Comparing the Combination of Selinexor-Daratumumab-Velcade-Dexamethasone (Dara-SVD) With the Usual Treatment (Dara-RVD) for High-Risk Newly Diagnosed Multiple Myeloma
ctrrecruit@vcu.edu
NCT06169215
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Inclusion Criteria:
* Presence of newly diagnosed (dx) multiple myeloma (MM) as defined by standard International Myeloma working group (IMWG).
* Presence of high risk cytogenetics using fluorescent in situ hybridization (FISH) \[del(17p), t(4;14), t(14;16), t(14;20), chromosome 1 abnormalities, MYC translocation, tetrasomies, complex karyotype, high lactate dehydrogenase (LDH), or extramedullary MM.
* Patients are allowed to have received one cycle of bortezomib-based doublet or triplet therapy. For instance, if a newly diagnosed patient with MM is in need of urgent therapy, they may be enrolled after having received one cycle of bortezomib, cyclophosphamide, dexamethasone.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%).
* Absolute neutrophil count ≥ 1,000/mcL (\> 500 if bone marrow \[BM\] clonal plasma cell involvement greater than 50%).
* Platelets ≥ 100,000/mcL (\> 50,000 if BM clonal plasma cell involvement greater than 50%).
* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (with the exception of patients with Gilbert's syndrome who have a high baseline bilirubin).
* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase \[SGPT\]) ≤ 3 × institutional ULN.
* Glomerular filtration rate (GFR) ≥ 30 mL/min.
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
* Patients with treated brain involvement are eligible if follow-up brain imaging performed within 10 days after central nervous system (CNS)-directed therapy shows no.
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
* The effects of selinexor (KPT-330) on the developing human fetus are unknown. For this reason and because selective nuclear export inhibitors as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men with partners of women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men (with partners of women of childbearing potential) treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study treatment administration. Adequate contraception should continue for 7 months for females and for 4 months for males after completion of the study treatment.
* Female of childbearing potential (FCBP) must have a negative pregnancy test during screening. They must either commit to continue abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before therapy, while taking lenalidomide, during dose interruptions, and for 7 months after study treatment. If menstrual cycles are irregular, the pregnancy testing should occur every 2 weeks. Pregnancy testing and counseling should be performed if a patient misses her period or if there is any abnormality in her menstrual bleeding. Lenalidomide treatment must be discontinued during this evaluation.
* Men who are sexually active with FCBP must agree to use a latex or synthetic condom while taking lenalidomide, during dose interruptions and for up to 4 weeks after discontinuing lenalidomide, even if they have undergone a successful vasectomy. Male patients taking lenalidomide must abstain from donating blood, semen, or sperm during study participation and for at least 4 weeks after discontinuation from lenalidomide.
* Patients who are randomized to receive lenalidomide need to register into the mandatory Risk Evaluation and Mitigation Strategies (REMS) program and be willing and able to comply with the requirements of REMS.
* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
Exclusion Criteria:
* Patients who are in urgent need for MM therapy (such as in the setting of acute kidney injury, or high disease burden concerning for impending organ failure) may begin study treatment immediately after receiving one cycle of bortezomib combination (e.g. bortezomib-dexamethasone or cyclophosphamide-bortezomib-dexamethasone) or one course of pulse dose dexamethasone 20-40mg once daily for four days. No washout period is required.
* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia.
* Patients who are receiving any other investigational agents.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to selinexor (KPT-330) or other agents used in study.
* Concomitant medications: Supportive care therapies such as bone directed therapies (zoledronic acid, denosumab), intravenous immunoglobulin therapy (IVIG) and anti-viral agents are allowed and recommended as per standard of care (SOC). Strong CYP3A4 inhibitors and strong CYP3A4 inducers are prohibited, due to their respective increase or decrease in bortezomib exposure. If strong CYP3A4 inhibitors cannot be avoided, then patients will be monitored for signs of bortezomib toxicity and a dose reduction of bortezomib will be considered.
* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous.
* Pregnant women are excluded because this study involves an investigational drug that may cause genotoxic, teratogenic, and mutagenic effects on the developing fetus and newborn and drugs that have known genotoxic, teratogenic, or abortifacient effect.
* Because there is potential risk for adverse events in nursing infants secondary to treatment of the mother with the drugs used in this study, breastfeeding is not allowed during treatment for all drugs and for 2 months after last dose of bortezomib and 1 week after the last dose of selinexor. PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, DRUG: Bortezomib, PROCEDURE: Computed Tomography, DRUG: Daratumumab and Recombinant Human Hyaluronidase, DRUG: Dexamethasone, DRUG: Lenalidomide, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Positron Emission Tomography, DRUG: Selinexor
Multiple Myeloma
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Study Locations
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| Location | Contacts |
|---|---|
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | Site Public Contact - (CancerTrials@nyulangone.org) |
| NYP/Weill Cornell Medical Center New York, New York | |
| NYU Langone Hospital - Brooklyn Brooklyn, New York | Site Public Contact - (david.wallach@nyulangone.org) |
| NYU Langone Hospital - Long Island Mineola, New York | Site Public Contact - (cancertrials@nyulangone.org) |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| Smilow Cancer Center/Yale-New Haven Hospital New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center - Guilford Guilford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center - Waterford Waterford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center - Westerly Westerly, Rhode Island | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center at Glastonbury Glastonbury, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center at Greenwich Greenwich, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center at Long Ridge Stamford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center at Saint Francis Hartford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center-Fairfield Fairfield, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center-Trumbull Trumbull, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Derby Care Center Derby, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Torrington Care Center Torrington, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Waterbury Care Center Waterbury, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California | Site Public Contact - (ucstudy@uci.edu) |
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine, California | Site Public Contact - (ucstudy@uci.edu) |
| UCI Health Laguna Hills Laguna Hills, California | Site Public Contact - (ucstudy@uci.edu) |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Yale-New Haven Hospital North Haven Medical Center North Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment
Sharon Palmer - spalmer@swog.org
NCT05561387
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Inclusion Criteria:
* Participants must have documented multiple myeloma satisfying standard International Myeloma Working Group (IMWG) diagnostic criteria within 28 days prior to registration
* Participants must have measurable disease within 28 days prior to registration as defined by any of the following:
* Immunoglobulin (Ig) G myeloma (serum monoclonal paraprotein \[M-protein\] level \>= 0.5 gram/deciliter \[g/dL\] or urine M-protein level \>= 200 milligram\[mg\]/24 hours\[hrs\]); OR
* IgA, IgM, IgD, or IgE multiple myeloma (serum M-protein level \>= 0.2 g/dL or urine M-protein level \>= 200 mg/24 hrs); OR
* Light chain multiple myeloma (serum immunoglobulin free light chain \>= 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio)
* All disease must be assessed and documented on the baseline/pre-registration tumor assessment form
* Participants must have a calculated myeloma frailty index (Myeloma Frailty Score Calculator; http://www.myelomafrailtyscorecalculator.net/) categorized as frail or intermediate fit (regardless of age) within 28 days prior to registration
* For Participants Meeting "Frail" Status:
* Participants with any degree of kidney dysfunction are allowed; however, participants on dialysis are not eligible
* For Participants Meeting "Frail" Status:
* Hemoglobin \>= 7 g/dL (must be performed within 28 days prior to registration)
* Note: growth factor and transfusion utilization are allowed if cytopenias are considered secondary to bone marrow involvement from MM)
* For Participants Meeting "Frail" Status:
* Platelets \>= 50 x 10\^9/L (must be performed within 28 days prior to registration)
* Note: growth factor and transfusion utilization are allowed if cytopenias are considered secondary to bone marrow involvement from MM)
* For Participants Meeting "Frail" Status:
* Absolute neutrophil count (ANC) \>= 0.75 x10\^9/L (must be performed within 28 days prior to registration)
* Note: growth factor and transfusion utilization are allowed if cytopenias are considered secondary to bone marrow involvement from MM)
* For Participants Meeting "Intermediate Fit" Status, one or more of the following criteria must be present:
* Kidney dysfunction showing calculated creatinine clearance (CrCl) \<30 ml/min.
* Actual lab serum creatinine value with a minimum of 0.7 mg/dL.
* Participants must have bone marrow function assessed and meet the below criteria ranges:
* Hemoglobin between 7-8 g/dL, OR
* Platelets between 50-75 x10\^9/L, OR
* ANC between 0.75-1 x10\^9/L
* Note: growth factor and transfusion utilization are allowed as long as cytopenias are considered secondary to bone marrow involvement from MM)
* Revised International Staging System (R-ISS) stage III disease
* Note: All labs must be performed within 28 days prior to registration
* Participants must have a complete medical history and physical exam within 28 days prior to registration
* Participants must have whole body imaging within 60 days prior to registration. The recommended method of imaging is a positron emission tomography/computed tomography (PET/CT); a low-dose whole body CT scan or whole-body magnetic resonance imaging (MRI) or skeletal survey should be done only if a PET/CT scan cannot be done or is non-feasible. This must be documented in the comments section of the Onstudy form.
* Total bilirubin =\< 2 times institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\< 5 x institutional ULN (within 28 days prior to registration)
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 × institutional ULN (within 28 days prior to registration)
* Participants must have adequate cardiac function, as assessed by the treating physician within 14 days prior to registration. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and must not be assessed as class 3 or 4
* Participants with known diabetes must show evidence of controlled disease within 14 days prior to registration. Uncontrolled diabetes is defined as: A glycosylated hemoglobin (Hg)A1C \> 7
* Participants with known human immunodeficiency virus (HIV)-infection must be receiving anti-retroviral therapy and have an undetectable viral load test on the most recent test result obtained, within 6 months prior to registration
* All participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within 28 days prior to registration
* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, participant must have an undetectable HCV viral load within 28 days prior to registration
* Participants must have an Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status score of 0-2 (Note: Participants with ECOG/Zubrod performance score \[PS\] 3, especially where the deterioration of PS is considered secondary to the MM diagnosis, will be allowed)
* Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) specimen tracking system
* Participants who are able to complete the patient-reported outcomes measures in English or Spanish must agree to participate in the PRO portion of the study
* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
Exclusion Criteria:
* Participants must not have received any prior systemic therapy for multiple myeloma with the exception of any one or more of the following:
* An emergency use of a short course of corticosteroids (equivalent of dexamethasone 160 mg) any time before registration, or
* Up to one complete cycle of a non-daratumumab and hyaluronidase-fihj containing anti-myeloma regimen (1 cycle = 21 or 28 days depending on the regimen being used), or
* Localized palliative radiation therapy for multiple myeloma, as long as the radiation therapy is completed at least 3 days prior to starting the systemic treatment as per the study protocol.
* Participants must not have evidence of grade 4 peripheral neuropathy prior to study registration
* Participants must not have uncontrolled blood pressure within 14 days prior to registration. Uncontrolled blood pressure: systolic blood pressure (SBP) \> 140 mmHg or diastolic blood pressure (DBP) \> 90 mmHg. Participants are permitted to be receiving multiple anti-hypertensive medications (unless otherwise indicated in the study). All blood pressure measurements within the 14 days prior to registration must be SBP =\< 140 and DBP =\< 90. A participant with a single blood pressure elevation who upon rechecking has a normal blood pressure will remain eligible at the discretion of the registering investigator.
* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
* Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 24 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen. DRUG: Bortezomib, DRUG: Daratumumab and Hyaluronidase-fihj, DRUG: Dexamethasone, DRUG: Lenalidomide, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration
Plasma Cell Myeloma
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Show 397 locations
Study Locations
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| Location | Contacts |
|---|---|
| 21st Century Oncology-Pontiac Pontiac, Michigan | Site Public Contact - (Emily.Crofts@trinity-health.org) |
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Academic Hematology Oncology Specialists Grosse Pointe Woods, Michigan | Site Public Contact - (karen.forman@ascension.org) |
| Advanced Breast Care Center PLLC Warren, Michigan | Site Public Contact - (karen.forman@ascension.org) |
| Alaska Breast Care and Surgery LLC Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Alaska Oncology and Hematology LLC Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Alaska Women's Cancer Care Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Alegent Health Bergan Mercy Medical Center Omaha, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Alegent Health Immanuel Medical Center Omaha, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Alegent Health Lakeside Hospital Omaha, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Alegent Health Mercy Hospital Council Bluffs, Iowa | |
| Anchorage Associates in Radiation Medicine Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Anchorage Oncology Centre Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Anchorage Radiation Therapy Center Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Armes Family Cancer Center Findlay, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Ascension Borgess Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Ascension Saint John Hospital Detroit, Michigan | Site Public Contact - (karen.forman@ascension.org) |
| Ascension Saint Joseph Hospital Tawas City, Michigan | Site Public Contact - (lori.srebinski@ascension.org) |
| Ascension Saint Mary's Hospital Saginaw, Michigan | Site Public Contact - (lori.srebinski@ascension.org) |
| Ascension Saint Mary's Hospital Saginaw, Michigan | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Ascension Saint Michael's Hospital Stevens Point, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids, Wisconsin | |
| Aspirus Medford Hospital Medford, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Aspirus Regional Cancer Center Wausau, Wisconsin | |
| Avera Cancer Institute Sioux Falls, South Dakota | Site Public Contact - (OncRegulatory@avera.org) |
| Avera Cancer Institute at Yankton Yankton, South Dakota | Site Public Contact - (OncRegulatory@avera.org) |
| Avera Cancer Institute-Aberdeen Aberdeen, South Dakota | Site Public Contact - (oncregulatory@avera.org) |
| BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri | |
| Bay Area Hospital Coos Bay, Oregon | Site Public Contact - (cherie.cox@bayareahospital.org) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Ben Taub General Hospital Houston, Texas | |
| Bethesda North Hospital Cincinnati, Ohio | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Bhadresh Nayak MD PC-Sterling Heights Sterling Heights, Michigan | Site Public Contact - (karen.forman@ascension.org) |
| Blanchard Valley Hospital Findlay, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Borgess Medical Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Bronson Battle Creek Battle Creek, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| CARTI Cancer center Little Rock, Arkansas | Site Public Contact - (Research@CARTI.com) |
| CHI Health Good Samaritan Kearney, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Cambridge Medical Center Cambridge, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Center at Saint Joseph's Phoenix, Arizona | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Cancer Center of Western Wisconsin New Richmond, Wisconsin | Site Public Contact - (mmcorc@healthpartners.com) |
| Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan | Site Public Contact - (connie.szczepanek@crcwm.org) |
| Capital Region Southwest Campus Jefferson City, Missouri | Site Public Contact - (amy.franken@health.missouri.edu) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Caro Cancer Center Caro, Michigan | Site Public Contact - (lori.srebinski@ascension.org) |
| Central Care Cancer Center - Bolivar Bolivar, Missouri | Site Public Contact - (aroland@kccop.org) |
| Central Care Cancer Center - Garden City Garden City, Kansas | Site Public Contact - (aroland@kccop.org) |
| Central Care Cancer Center - Great Bend Great Bend, Kansas | Site Public Contact - (aroland@kccop.org) |
| Centralia Oncology Clinic Centralia, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Clackamas Radiation Oncology Center Clackamas, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Commonwealth Cancer Center-Corbin Corbin, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Community Medical Center Toms River, New Jersey | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan | |
| Corewell Health Reed City Hospital Reed City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Cox Cancer Center Branson Branson, Missouri | |
| CoxHealth South Hospital Springfield, Missouri | |
| Creighton University Medical Center Omaha, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dayton Physician LLC-Miami Valley Hospital North Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Dayton Physicians LLC - Troy Troy, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Dayton Physicians LLC-Atrium Franklin, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Dayton Physicians LLC-Miami Valley South Centerville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Dayton Physicians LLC-Wayne Greenville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Delbert Day Cancer Institute at PCRMC Rolla, Missouri | Site Public Contact - (research@phelpshealth.org) |
| Duluth Clinic Ashland Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Edward Hines Jr VA Hospital Hines, Illinois | |
| Essentia Health - Baxter Clinic Baxter, Minnesota | |
| Essentia Health - Deer River Clinic Deer River, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health - Ely Clinic Ely, Minnesota | |
| Essentia Health - Fosston Fosston, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health - International Falls Clinic International Falls, Minnesota | |
| Essentia Health - Jamestown Clinic Jamestown, North Dakota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health - Moose Lake Clinic Moose Lake, Minnesota | |
| Essentia Health - Park Rapids Park Rapids, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Cancer Center Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Cancer Center-South University Clinic Fargo, North Dakota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Hibbing Clinic Hibbing, Minnesota | |
| Essentia Health Saint Joseph's Medical Center Brainerd, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Saint Mary's - Detroit Lakes Clinic Detroit Lakes, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Saint Mary's Hospital - Superior Superior, Wisconsin | |
| Essentia Health Saint Mary's Medical Center Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Sandstone Sandstone, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Virginia Clinic Virginia, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health-Hayward Clinic Hayward, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health-Spooner Clinic Spooner, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Exeter Hospital Exeter, New Hampshire | |
| Fairview Clinics and Surgery Center Maple Grove Maple Grove, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Lakes Medical Center Wyoming, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Northland Medical Center Princeton, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Flaget Memorial Hospital Bardstown, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Freeman Health System Joplin, Missouri | Site Public Contact - (LJCrockett@freemanhealth.com) |
| Fremont - Rideout Cancer Center Marysville, California | |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Geisinger Medical Oncology-Lewisburg Lewisburg, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Gene Upshaw Memorial Tahoe Forest Cancer Center Truckee, California | |
| Genesee Cancer and Blood Disease Treatment Center Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Genesee Hematology Oncology PC Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Genesys Hurley Cancer Institute Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Good Samaritan Hospital - Cincinnati Cincinnati, Ohio | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Good Samaritan Regional Health Center Mount Vernon, Illinois | |
| Great Lakes Cancer Management Specialists-Doctors Park East China Township, Michigan | Site Public Contact - (karen.forman@ascension.org) |
| Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb, Michigan | Site Public Contact - (karen.forman@ascension.org) |
| Great Lakes Cancer Management Specialists-Macomb Professional Building Warren, Michigan | Site Public Contact - (karen.forman@ascension.org) |
| Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods, Michigan | Site Public Contact - (karen.forman@ascension.org) |
| Greater Baltimore Medical Center Baltimore, Maryland | |
| Greater Dayton Cancer Center Kettering, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Greater Regional Medical Center Creston, Iowa | Site Public Contact - (cancerresearch@mercydesmoines.org) |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | Site Public Contact - (cancerctr@gundersenhealth.org) |
| HSHS Saint Elizabeth's Hospital O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Harrison Medical Center Bremerton, Washington | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Health Partners Inc Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Heartland Regional Medical Center Saint Joseph, Missouri | Site Public Contact - (linda.schumacher@mymlc.com) |
| Helen DeVos Children's Hospital at Spectrum Health Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Hematology Oncology Consultants-Clarkston Clarkston, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Hennepin County Medical Center Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Holy Cross Hospital Fort Lauderdale, Florida | Site Public Contact - (eileen.georgi@holy-cross.com) |
| Hope Cancer Center Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Hurley Medical Center Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Huron Gastroenterology PC Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| IU Health North Hospital Carmel, Indiana | Site Public Contact - (iutrials@iu.edu) |
| Illinois CancerCare - Washington Washington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Bloomington Bloomington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Canton Canton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Carthage Carthage, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Dixon Dixon, Illinois | |
| Illinois CancerCare-Eureka Eureka, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Galesburg Galesburg, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Kewanee Clinic Kewanee, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Macomb Macomb, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Ottawa Clinic Ottawa, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Pekin Pekin, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peoria Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peru Peru, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Princeton Princeton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana | Site Public Contact - (iutrials@iu.edu) |
| Indu and Raj Soin Medical Center Beavercreek, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| John L McClellan Memorial Veterans Hospital Little Rock, Arkansas | |
| Jupiter Medical Center Jupiter, Florida | |
| Kadlec Clinic Hematology and Oncology Kennewick, Washington | Site Public Contact - (research@kadlecmed.org) |
| Katmai Oncology Group Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Kettering Medical Center Newark, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Lake Regional Hospital Osage Beach, Missouri | Site Public Contact - (clinicaltrials@lakeregional.com) |
| Lakeland Medical Center Saint Joseph Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Lakeview Hospital Stillwater, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Langlade Hospital and Cancer Center Antigo, Wisconsin | Site Public Contact - (Juli.Alford@aspirus.org) |
| Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Lehigh Valley Hospital-Hazleton Hazleton, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Littleton Adventist Hospital Littleton, Colorado | |
| Longmont United Hospital Longmont, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Lovelace Medical Center-Saint Joseph Square Albuquerque, New Mexico | Site Public Contact - (AYost@nmcca.org) |
| Loyola Center for Health at Burr Ridge Burr Ridge, Illinois | |
| Loyola Medicine Homer Glen Homer Glen, Illinois | |
| Loyola University Medical Center Maywood, Illinois | |
| M D Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MD Anderson League City League City, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MD Anderson West Houston Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MD Anderson in Sugar Land Sugar Land, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MD Anderson in The Woodlands Conroe, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| Macomb Hematology Oncology PC Warren, Michigan | Site Public Contact - (karen.forman@ascension.org) |
| Marjorie Weinberg Cancer Center at Loyola-Gottlieb Melrose Park, Illinois | |
| Marshall Cancer Center Cameron Park, California | Site Public Contact - (cancerservices@marshallmedical.org) |
| Marshfield Clinic - Ladysmith Center Ladysmith, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Clinic-Chippewa Center Chippewa Falls, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Clinic-Minocqua Center Minocqua, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Clinic-Wausau Center Wausau, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center - Neillsville Neillsville, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center - Weston Weston, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-Rice Lake Rice Lake, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Mayo Clinic in Florida Jacksonville, Florida | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| Medical Oncology and Hematology Associates-West Des Moines Clive, Iowa | |
| Memorial Hospital of Carbondale Carbondale, Illinois | Site Public Contact - (clinical.research@sih.net) |
| Memorial Medical Center Modesto, California | Site Public Contact - (pallante.beth@mhsil.com) |
| Mercy Cancer Center - Carmichael Carmichael, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Cancer Center - Elk Grove Elk Grove, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Cancer Center - Rocklin Rocklin, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Cancer Center - Sacramento Sacramento, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Cancer Center-West Lakes Clive, Iowa | Site Public Contact - (cancerresearch@mercydesmoines.org) |
| Mercy Clinic-Rolla-Cancer and Hematology Rolla, Missouri | |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mercy Hospital Fort Smith Fort Smith, Arkansas | |
| Mercy Hospital Joplin Joplin, Missouri | Site Public Contact - (esmeralda.carrillo@mercy.net) |
| Mercy Hospital Oklahoma City Oklahoma City, Oklahoma | |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Mercy Hospital South St Louis, Missouri | Site Public Contact - (Danielle.Werle@mercy.net) |
| Mercy Hospital Springfield Springfield, Missouri | |
| Mercy Hospital Washington Washington, Missouri | |
| Mercy Medical Center Springfield, Massachusetts | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mercy Medical Center - Des Moines Des Moines, Iowa | Site Public Contact - (cancerresearch@mercydesmoines.org) |
| Mercy Medical Center-West Lakes West Des Moines, Iowa | Site Public Contact - (cancerresearch@mercydesmoines.org) |
| Mercy San Juan Medical Center Carmichael, California | Site Public Contact - (OncologyResearch@DignityHealth.org) |
| Mercy UC Davis Cancer Center Merced, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Methodist Medical Center of Illinois Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Michael E DeBakey VA Medical Center Houston, Texas | |
| Michigan Breast Specialists-Warren Warren, Michigan | Site Public Contact - (karen.forman@ascension.org) |
| Midlands Community Hospital Papillion, Nebraska | |
| Miller-Dwan Hospital Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Minnesota Oncology - Burnsville Burnsville, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mission Cancer and Blood - Ankeny Ankeny, Iowa | |
| Mission Cancer and Blood - Laurel Des Moines, Iowa | |
| Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Mission Hope Medical Oncology - Santa Maria Santa Maria, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Missouri Baptist Medical Center St Louis, Missouri | |
| Missouri Baptist Sullivan Hospital Sullivan, Missouri | |
| Monticello Cancer Center Monticello, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Munson Medical Center Traverse City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York | Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu) |
| New Ulm Medical Center New Ulm, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Newland Medical Associates-Clarkston Clarkston, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Newland Medical Associates-Pontiac Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| North Memorial Medical Health Center Robbinsdale, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Northwest Cancer Center - Hobart Hobart, Indiana | |
| Northwest Cancer Center - Main Campus Crown Point, Indiana | |
| Northwest Cancer Center - Valparaiso Valparaiso, Indiana | Site Public Contact - (CancerResearch@COMHS.org) |
| Northwest Oncology LLC Dyer, Indiana | |
| Northwest Wisconsin Cancer Center Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Oncology Hematology Associates of Saginaw Valley PC Saginaw, Michigan | Site Public Contact - (lori.srebinski@ascension.org) |
| Oncology Hematology Care Inc-Kenwood Cincinnati, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Orion Cancer Care Findlay, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Parker Adventist Hospital Parker, Colorado | |
| Parkland Health Center - Farmington Farmington, Missouri | |
| PeaceHealth Saint John Medical Center Longview, Washington | Site Public Contact - (kmakin-bond@peacehealth.org) |
| PeaceHealth Saint Joseph Medical Center Bellingham, Washington | |
| PeaceHealth Southwest Medical Center Vancouver, Washington | Site Public Contact - (kmakin-bond@peacehealth.org) |
| PeaceHealth United General Medical Center Sedro-Woolley, Washington | Site Public Contact - (lkey@peacehealth.org) |
| Penrose-Saint Francis Healthcare Colorado Springs, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Physicians' Clinic of Iowa PC Cedar Rapids, Iowa | |
| Pocono Medical Center East Stroudsburg, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Porter Adventist Hospital Denver, Colorado | |
| Presbyterian Kaseman Hospital Albuquerque, New Mexico | Site Public Contact - (WBurman@phs.org) |
| Presbyterian Rust Medical Center/Jorgensen Cancer Center Rio Rancho, New Mexico | Site Public Contact - (WBurman@phs.org) |
| Prisma Health Cancer Institute - Butternut Greenville, South Carolina | |
| Prisma Health Cancer Institute - Easley Easley, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Eastside Greenville, South Carolina | |
| Prisma Health Cancer Institute - Faris Greenville, South Carolina | |
| Prisma Health Cancer Institute - Greer Greer, South Carolina | |
| Prisma Health Cancer Institute - Seneca Seneca, South Carolina | |
| Prisma Health Cancer Institute - Spartanburg Boiling Springs, South Carolina | |
| Providence Alaska Medical Center Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Providence Cancer Institute Clackamas Clinic Clackamas, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Medical Foundation - Santa Rosa Santa Rosa, California | |
| Providence Newberg Medical Center Newberg, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Portland Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Queen of The Valley Napa, California | |
| Providence Regional Cancer Partnership Everett, Washington | Site Public Contact - (marilyn.birchman@providence.org) |
| Providence Regional Cancer System-Aberdeen Aberdeen, Washington | Site Public Contact - (deidre.dillon@providence.org) |
| Providence Regional Cancer System-Centralia Centralia, Washington | Site Public Contact - (deidre.dillon@providence.org) |
| Providence Regional Cancer System-Lacey Lacey, Washington | Site Public Contact - (deidre.dillon@providence.org) |
| Providence Regional Cancer System-Shelton Shelton, Washington | Site Public Contact - (deidre.dillon@providence.org) |
| Providence Regional Cancer System-Yelm Yelm, Washington | Site Public Contact - (deidre.dillon@providence.org) |
| Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank, California | Site Public Contact - (Najee.Boucher@providence.org) |
| Providence Saint Mary Regional Cancer Center Walla Walla, Washington | Site Public Contact - (Cheryl.Dodd@providence.org) |
| Providence Saint Vincent Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Santa Rosa Memorial Hospital Santa Rosa, California | |
| Providence Willamette Falls Medical Center Oregon City, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Reid Health Richmond, Indiana | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Research Medical Center Kansas City, Missouri | Site Public Contact - (aroland@kccop.org) |
| Rice Memorial Hospital Willmar, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Ridgeview Medical Center Waconia, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Riverwood Healthcare Center Aitkin, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Rocky Mountain Cancer Centers-Penrose Colorado Springs, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Rocky Mountain Regional VA Medical Center Aurora, Colorado | |
| Rogue Valley Medical Center Medford, Oregon | Site Public Contact - (research@asante.org) |
| Rush - Copley Medical Center Aurora, Illinois | Site Public Contact - (Cancer.Research@rushcopley.com) |
| Rush-Copley Healthcare Center Yorkville, Illinois | Site Public Contact - (Cancer.Research@rushcopley.com) |
| SIH Cancer Institute Carterville, Illinois | Site Public Contact - (clinical.research@sih.net) |
| Saint Anthony Hospital Lakewood, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Anthony's Health Alton, Illinois | |
| Saint Catherine Hospital Indianapolis, Indiana | Site Public Contact - (protocols@swog.org) |
| Saint Charles Health System Bend, Oregon | Site Public Contact - (nosall@stcharleshealthcare.org) |
| Saint Charles Health System-Redmond Redmond, Oregon | |
| Saint Elizabeth Boardman Hospital Boardman, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Saint Elizabeth Regional Medical Center Lincoln, Nebraska | |
| Saint Elizabeth Youngstown Hospital Youngstown, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Saint Francis Cancer Center Greenville, South Carolina | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Saint Francis Regional Medical Center Shakopee, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint John Macomb-Oakland Hospital Warren, Michigan | Site Public Contact - (karen.forman@ascension.org) |
| Saint John's Hospital - Healtheast Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint Joseph Hospital Nashua, New Hampshire | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Joseph Hospital East Lexington, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Joseph London London, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Joseph Medical Center Tacoma, Washington | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Saint Joseph Mercy Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Saint Joseph Mercy Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Saint Joseph Mercy Chelsea Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Saint Joseph Mercy Hospital Ann Arbor, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Saint Joseph Mercy Oakland Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Saint Joseph Mount Sterling Mount Sterling, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Joseph Radiation Oncology Resource Center Lexington, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Joseph Warren Hospital Warren, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Saint Louis Cancer and Breast Institute-Ballwin Ballwin, Missouri | |
| Saint Louis Cancer and Breast Institute-South City St Louis, Missouri | |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Meridian Meridian, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Nampa Nampa, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Twin Falls Twin Falls, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Mary Corwin Medical Center Pueblo, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Mary Medical Center Hobart, Indiana | Site Public Contact - (CancerResearch@COMHS.org) |
| Saint Mary's Hospital Rhinelander, Wisconsin | Site Public Contact - (protocols@swog.org) |
| Saint Mary's Oncology/Hematology Associates of Marlette Marlette, Michigan | Site Public Contact - (lori.srebinski@ascension.org) |
| Saint Mary's Oncology/Hematology Associates of West Branch West Branch, Michigan | Site Public Contact - (lori.srebinski@ascension.org) |
| Saint Patrick Hospital - Community Hospital Missoula, Montana | Site Public Contact - (amy.hanneman@providence.org) |
| Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri | |
| Sanford Bismarck Medical Center Bismarck, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicTrialsSF@sanfordhealth.org) |
| Sanford Cancer Center Worthington Worthington, Minnesota | |
| Sanford Joe Lueken Cancer Center Bemidji, Minnesota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Medical Center Fargo Fargo, North Dakota | |
| Sanford Roger Maris Cancer Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford South University Medical Center Fargo, North Dakota | |
| Sanford Thief River Falls Medical Center Thief River Falls, Minnesota | |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Smilow Cancer Center/Yale-New Haven Hospital New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center - Guilford Guilford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center - Waterford Waterford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center - Westerly Westerly, Rhode Island | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center at Glastonbury Glastonbury, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center at Greenwich Greenwich, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center at Long Ridge Stamford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center at Saint Francis Hartford, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center-Fairfield Fairfield, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital Care Center-Trumbull Trumbull, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Derby Care Center Derby, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Torrington Care Center Torrington, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Smilow Cancer Hospital-Waterbury Care Center Waterbury, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Southeast Cancer Center Cape Girardeau, Missouri | |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Southpointe-Sanford Medical Center Fargo Fargo, North Dakota | |
| Southwest Oncology PC Durango, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Sovah Health Martinsville Martinsville, Virginia | Site Public Contact - (sharon.hubbard@lpnt.net) |
| Spectrum Health at Butterworth Campus Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Springfield Clinic Springfield, Illinois | |
| Swedish Cancer Institute-Edmonds Edmonds, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Cancer Institute-Issaquah Issaquah, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Medical Center-Ballard Campus Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Medical Center-Cherry Hill Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Medical Center-First Hill Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| The Carle Foundation Hospital Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| The Community Hospital Munster, Indiana | |
| ThedaCare Regional Cancer Center Appleton, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| TriHealth Cancer Institute-Anderson Cincinnati, Ohio | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| TriHealth Cancer Institute-Westside Cincinnati, Ohio | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Trinity Health Grand Rapids Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Muskegon Hospital Muskegon, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Unity Hospital Fridley, Minnesota | |
| University of Arkansas for Medical Sciences Little Rock, Arkansas | |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Iowa Healthcare Cancer Services Quad Cities Bettendorf, Iowa | Site Public Contact - (kedaprile@rccqc.com) |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Michigan Health - Sparrow Lansing Lansing, Michigan | Site Public Contact - (harsha.trivedi@umhsparrow.org) |
| University of Michigan Health - West Wyoming, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Rochester Rochester, New York | |
| University of Texas Health Science Center at San Antonio San Antonio, Texas | Site Public Contact - (phoresearchoffice@uthscsa.edu) |
| VCU Community Memorial Health Center South Hill, Virginia | Site Public Contact - (nemer.elmouallem@vcuhealth.org) |
| VCU Massey Cancer Center at Stony Point Richmond, Virginia | Site Public Contact - (ctoclinops@vcu.edu) |
| Valley Radiation Oncology Peru, Illinois | |
| Virginia Cancer Institute Richmond, Virginia | Site Public Contact - (smoore@vacancer.com) |
| Virginia Commonwealth University/Massey Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Wayne Hospital Greenville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| West Michigan Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| West Virginia University Charleston Division Charleston, West Virginia | |
| Western Illinois Cancer Treatment Center Galesburg, Illinois | |
| Women's Diagnostic Center - Munster Munster, Indiana | Site Public Contact - (mnicholson@comhs.org) |
| Woodland Memorial Hospital Woodland, California | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| Yale-New Haven Hospital North Haven Medical Center North Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
NS-089/NCNP-02-201 in Boys With Duchenne Muscular Dystrophy (DMD)
Trial info - trialinfo@nspharma.com
NCT05996003
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Inclusion Criteria:
* Male ≥ 4 years and \<15 years of age
* Confirmed DMD mutation(s) in the dystrophin gene that is amenable to skipping of exon 44 to restore the dystrophin mRNA reading frame
* Able to walk independently without assistive devices
* Ability to complete the TTSTAND without assistance in \<20 seconds
* Stable dose of glucocorticoid for at least 3 months and the dose is expected to remain on a stable dose for the duration of the study.
* Other inclusion criteria may apply.
Exclusion Criteria:
* Has a body weight of \<20 kg at the time of informed consent (applies to participants screening for Part 1 only)
* Evidence of symptomatic cardiomyopathy
* Current or previous treatment with anabolic steroids (e.g., oxandrolone) or products containing resveratrol or adenosine triphosphate within 3 months prior to first dose of study drug
* Current or previous treatment with any other investigational drug within 3 months prior to the first dose of study drug or within 5 times the half-life of a medication, whichever is longer
* Surgery within the 3 months prior to the first dose of study drug or planned during the study duration
* Previously treated in an interventional study of NS-089/NCNP-02
* Having taken any gene therapy.
* Having received exon skipping oligonucleotide within 1 year prior to the first dose of IP or is expected to receive exon skipping oligonucleotide prior to completion of study.
* Other exclusion criteria may apply. DRUG: NS-089/NCNP-02
Duchenne Muscular Dystrophy, Exon 44, DMD
Exon 44 Skipping, DMD
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Study Locations
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| Location | Contacts |
|---|---|
| Alberta Children's Hospital Calgary, Alberta | Julie Dao - (julie.dao@ucalgary.ca) |
| Ann and Robert H. Lurie Children's Hospital of Chicago Chicago, Illinois | Raven Hill - (rhill@luriechildrens.org) Alka Maheshwari - (amaheshwari@luriechildrens.org) |
| Children's Hospital Colorado Aurora, Colorado | Hannah Kleiner - (hannah.kleiner@childrenscolorado.org) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Angela Edmondson - (Angela.Edmondson@cchmc.org) |
| London Health Sciences Centre London, | Teresa Longfield - (teresa.longfield@lhsc.on.ca) |
| NHO Osaka Toneyama Medical Center Toyonaka, Osaka | Clinical Trial Office - (410-chiken@mail.hosp.go.jp) |
| National Center of Neurology and Psychiatry Kodaira, Tokyo | |
| National Hospital Organization Nagara Medical Center Nagara, Gifu-shi, Gifu | Clinical Trial Management Office - (yonekura.kei.wu@mail.hosp.go.jp) |
| Pusan National University Yangsan Hospital Yangsan, Gyeongsangnam-do | JaeYoon Kim - (lusterwuzz@naver.com) |
| Rare Disease Research Atlanta, Georgia | Julia Zhu - (julia.zhu@rarediseaseresearch.com) |
| Rare Disease Research, LLC - FL Kissimmee, Florida | Marcial Almaraz - (marcial.almaraz@rarediseaseresearch.com) |
| Seoul National University Hospital Seoul, Seoul Teugbyeolsi | Hyeon Ju Kwon - (hjkwon@snuh.org; 49041@snuh.org) |
| Shiga General Hospital Moriyama-shi, Shiga | Children's Building - (kenji.s.address@gmail.com) |
| UT Southwestern/Children's Health Dallas, Texas | Deniece Winston - (Deniece.Winston@UTSouthwestern.edu) |
| University of Kansas Medical Center (KUMC) Kansas City, Kansas | Rebecca Clay - (rclay@kumc.edu) |
| University of Pittsburgh School of Medicine Pittsburgh, Pennsylvania | Vibha Chauhan - (vibha.chauhan@chp.edu) |
| Virginia Commonwealth University Health System Richmond, Virginia | Andrea Jewell - (andrea.jewell@vcuhealth.org) |
Advancing Water Security: A Community Participatory School-Based Hydration Intervention
Sarah Farthing, MS - sarah.malone@vcuhealth.org
NCT06714929
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Inclusion Criteria:
* Lunchroom observations: All students (K-5th \[Pre-Kindergarten if applicable\]) who eat lunch in the cafeteria on assessment days are eligible
* BMI and dental caries assessments: 1) student enrolls in study while in 3rd grade (followed through 5th g)
* Student surveys: Students in 4th-5th grade are eligible to complete surveys assessing beverage intake and perceptions of hydration practices within their school district.
* Staff surveys: All staff in the target schools will be eligible to complete the Personnel Survey.
Exclusion Criteria:
* Lunchroom observations: None.
* BMI and dental caries assessments: Students are ineligible if they are unable to complete assessments due to developmental or physical reasons, 2) planning to move in the study duration
* Student surveys: None.
* Staff surveys: None. BEHAVIORAL: Hydration
Dental Caries, Obesity Prevention
hydration, water, sugar-sweetened beverages, dental caries, overweight and obesity
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| Location | Contacts |
|---|---|
| Children's Hospital of Richmond at VCU Healthy Lifestyles Center Henrico, Virginia | Sarah M Farthing, MS - (sarah.malone@vcuhealth.org) Melanie K Bean, PhD - (melanie.bean@vcuhealth.org) |
Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD
Joseph T Hull, PhD - jhull@supernus.com
NCT04781140
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Inclusion Criteria:
• Is male or female 4 years 0 months of age to less than or equal to 5 years 9 months of age at Visit 1 (Screening) and considered medically healthy.
• Subject's parent(s) or legal guardian(s)/representative(s) is (are) willing and able to provide written informed consent before completing any study related procedures.
• Has a primary diagnosis of ADHD according to DSM-IV-TR criteria and confirmed with the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version (K-SADS-PL).
• Has an ADHD-RS-IV-P Total Score of ≥ 28 (males) or ≥ 24 (females) at Visit 1 (Screening) and at Visit 2 (Baseline).
• Has a CGI-S score of ≥ 4 (moderate or worse) at Visit 1 (Screening) and at Visit 2 (Baseline).
• Has undergone an adequate course of non-pharmacologic treatment or is having symptoms severe enough to warrant pharmacologic treatment without prior non-pharmacologic treatment.
• Is participating in a structured group activity (e.g., preschool, kindergarten, sports, Sunday school, summer camp or childcare program) at least 2 days a week during study so as to assess symptoms and impairment in a setting outside the home.
• Has not initiated any behavioral intervention/therapy within 30 days of Visit 1 (Screening) and does not plan to initiate any new or discontinue any ongoing behavioral intervention/therapy during the study (e.g., subject is eligible if behavioral intervention/therapy is initiated 30 or more days prior to Visit 1 \[Screening\] and continues with a similar duration/frequency throughout their study).
• Subjects who are on ADHD medication at Visit 1 (Screening), but whose ADHD symptoms are not well controlled on current ADHD medication (e.g., meets Inclusion Criterion #4), meet all other inclusion/exclusion criteria, and discontinues ADHD medication at least 7 days prior to the day of Visit 2 (Baseline) are eligible to participate.
• Has no current condition in the opinion of the Investigator that could confound efficacy assessments, safety assessments or increase participant risk.
• Has lived with the same parent(s) or legal guardian(s) or has lived under a shared living arrangement (e.g., joint legal custody) for greater than or equal to 6 months prior to Visit 1 (Screening).
• Has a body weight ≥5th percentile for age and sex at Visit 1 (Screening) and Visit 2 (Baseline).
Exclusion Criteria:
• Has a diagnosis at Screening (per K-SADS-PL) of another psychiatric disorder that is considered to be the primary diagnosis rather than ADHD or has a comorbid psychiatric disorder secondary to ADHD that, in the opinion of the investigator (after consulting medical monitor), will likely interfere with study treatment adherence and/or impact study results.
• Has a current diagnosis of a major neurological disorder. The eligibility of those who have seizures, a history of seizure-like events (e.g., syncope, myoclonus, severe muscle spasms), a family history of seizure disorder (immediate family, i.e., sibling, parent), and/or febrile seizures will be assessed on a case-by-case basis after consulting the medical monitor.
• History of Bipolar Disorder diagnosed in a first degree relative.
• Has global development delay or intellectual disability by medical history.
• Has a current diagnosis of a significant (per Investigator's evaluation and/or judgement) systemic disease.
• Has body mass index \> 95th percentile for the subject's age and sex at Visit 1 (Screening) or Visit 2 (Baseline).
• Has a mean resting systolic and diastolic blood pressure\* that are both \>95th percentile for age sex, and height and has a mean resting pulse rate\* that is \>95th percentile for age and sex (males: \>117 bpm; females: \>122 bpm) at Visit 1 (Screening) or Visit 2 (Baseline). \* Note: The mean of three measurements while seated.
• Has a clinically significant electrocardiogram finding(s) at Visit 1 (Screening).
• Is currently taking SPN-812 for ADHD, has previously taken SPN-812 for ADHD, but discontinued due to a lack of efficacy or adverse reactions, or has history of allergic reaction, hypersensitivity or intolerance to viloxazine.
• Has an allergy to or cannot swallow pudding and applesauce and cannot swallow intact capsule whole.
• Has any food allergy, intolerance, restriction or special diet that, in the opinion of the Investigator, could contraindicate the subject's participation in the study.
• Has received any investigational drug within the longer of 30 days or 5 half-lives prior to Visit 2 (e.g., first dose of study medication).
• Has a positive urine drug test at Visit 1 (Screening). A positive test for amphetamines is allowed for subjects receiving a stimulant ADHD medication at Screening. The subject will be required to discontinue the stimulant for the duration of the study, beginning at least 7 days prior to Visit 2 (Baseline).
• Is using of prohibited concomitant medications including known CYP1A2 substrates (e.g., theophylline, melatonin) during the Screening Period or (anticipated) for the duration of the study.
• Any reason that, in the opinion of the Investigator, would prevent the subject from participating in the study.
• Has suicidal ideation ("Yes" indicated on C-SSRS question 4 or 5) or suicidal behavior ("Yes" indicated on C-SSRS for any suicidal behavior) within 6 months prior to or the day of Visit 1 (Screening) or has attempted suicide ("Yes" indicated on C-SSRS for lifetime).
DRUG: 100mg SPN-812, DRUG: Placebo
Attention-Deficit/Hyperactivity Disorder
ADHD
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Study Locations
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| Location | Contacts |
|---|---|
| AIM Trials Plano, Texas | - (info@aimtrials.com) |
| APG Research LLC Orlando, Florida | - (Mollie@apghealth.com) |
| Accel Research Sites-LKD CRU Lakeland, Florida | - (recruiting@accelclinical.com) |
| Advanced Discovery Research LLC Atlanta, Georgia | - (contact@advdiscovery.com) |
| Advanced Research Center (ARC), Inc. Anaheim, California | - (contact@arctrials.com) |
| Alliance Research Long Beach, California | - (Research@asclepes.com) |
| Avantis Clinical Research LLC Miami, Florida | - (info@avantisclinicalresearch.com) |
| CenExcel iResearch, LLC Decatur, Georgia | |
| CenExel iResearch, LLC. Savannah, Georgia | |
| Cincinnati Children's Hospital and Medical Center Cincinnati, Ohio | - (clinicalstudies@cchmc.org) |
| CincyScience West Chester, Ohio | - (research@cincyscience.com) |
| Clinical Integrative Research Center of Atlanta Atlanta, Georgia | |
| Clinical NeuroScience Solutions, Inc. Memphis, Tennessee | |
| Clinical NeuroScience Solutions, Inc. Memphis, Tennessee | |
| Clinical NeuroScience Solutions, Inc. Memphis, Tennessee | |
| Clinical Research Partners, LLC Richmond, Virginia | |
| Clinical Research of Southern Nevada, LLC. Las Vegas, Nevada | - (kluna.cpbm@gmail.com) |
| Coastal Carolina Research Center North Charleston, South Carolina | - (CCRC@CoastalCarolinaResearch.com) |
| Coastal Pediatric Research Summerville, South Carolina | - (info.research@cpakids.com) |
| Cyn3rgy Research Gresham, Oregon | - (support@cyn3rgy.com) |
| D&H Tamarac Research Center Tamarac, Florida | - (info@dhnrc.com) |
| DelRicht Research Baton Rouge, Louisiana | - (info@delricht.com) |
| DelRicht Research (Touro Medical Center) New Orleans, Louisiana | - (info@delricht.com) |
| Duke University Durham, North Carolina | |
| Family Psych of The Woodlands The Woodlands, Texas | - (info@woodlandspsych.com) |
| Hassman Research Institute Berlin, New Jersey | |
| Hope Research Network, LLC. Miami, Florida | - (info@hoperesearchnetwork.com) |
| Houston Clinical Trials, LLC. Bellaire, Texas | |
| IMMUNOe Research Centers Centennial, Colorado | - (verosinfo@veroshealth.com) |
| Icahn School of Medicine at Mount Sinai New York, New York | |
| Javara Dallas, Texas | |
| Kennedy Krieger Institute Baltimore, Maryland | |
| Kentucky Pediatric/Adult Research Bardstown, Kentucky | - (kpar@kpar.us) |
| Luna Research Center Coral Gables, Florida | |
| Med Clinical Research Irvington, New Jersey | - (info@medclinicalresearch.com) |
| Medical Research Group of Central Florida Orange City, Florida | |
| National Institute of Clinical Research (NICR) Garden Grove, California | |
| Neurobehavioral Medicine Group Bloomfield Hills, Michigan | - (info@neurobmg.com) |
| Precise Research Centers Flowood, Mississippi | |
| Preferred Research Partners - NWA, LLC Fayetteville, Arkansas | |
| Preferred Research Partners, Inc. Little Rock, Arkansas | - (info@preferredresearchpartners.com) |
| Qualmedica Research, LLC. Owensboro, Kentucky | |
| Qualmedica Research, LLC. Owensboro, Kentucky | |
| Sarkis Clinical Trials Gainesville, Florida | |
| Sun Valley Research Center Imperial, California | - (svrcinfo@sunvalleyb.com) |
| The Center for Clinical Trials, Inc. Saraland, Alabama | - (info@thecenterforclinicaltrials.com) |
| Virginia Commonwealth University, Virginia Treatment Center for Children Richmond, Virginia |
HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants (ESTHI)
Nichol Nunn - nichol.nunn@hsc.utah.edu
NCT04177914
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Inclusion Criteria:
• Corrected age \<104 weeks and 0 days, AND
• Child is ≥ 37 weeks post menstrual age, AND
• Child must have symptomatic hydrocephalus, defined as: Ventriculomegaly on MRI (frontal-occipital horn ratio (FOR) \>0.45, which approximates "moderate ventriculomegaly"), and at least one of the following: * Head circumference \>98th percentile for corrected age with either bulging fontanelle or splayed sutures * Upgaze paresis/palsy (sundowning) * CSF leak * Papilledema * Tense pseudomeningocele or tense fluid along a track * Vomiting or irritability, with no other attributable cause * Bradycardias or apneas, with no other attributable cause * Intracranial pressure (ICP) monitoring showing persistent elevation of pressure with or without plateau waves AND
• No prior history of shunt insertion or endoscopic third ventriculostomy (ETV) procedure (previous temporization devices and/or external ventricular drains permissible)
Exclusion Criteria:
• Hydrocephalus due to intraventricular hemorrhage in a child born before 37 weeks gestational age; OR
• Anatomy not suitable for ETV+CPC or anteriorly placed ventriculoperitoneal shunt defined as: * Moderate to severe prepontine adhesions on steady state free precession (SSFP) or T2 weighted fast (turbo) spin echo (FSE/TSE) MRI, which includes the following sequences: FIESTA, FIESTA-C, TrueFISP, CISS, Balanced FFE (bFFE), CUBE, SPACE, VISTA, IsoFSE, and 3D MVOX * Closure of one or both foramina of Monro * Thick floor of third ventricle (≥ 3mm) * Narrow third ventricle (\<5mm) * Presence of scalp, bone, or ventricular lesions that make placement of an anterior shunt impracticable; OR
• Underlying condition with a high chance of mortality within 12 months; OR
• Hydrocephalus with loculated CSF compartments; OR
• Peritoneal cavity not suitable for distal shunt placement; OR
• Active CSF infection; OR
• Hydranencephaly; OR
• Child requires an intraventricular procedure (e.g. endoscopic biopsy) in addition to the initial first-time permanent procedure for the treatment of hydrocephalus.
PROCEDURE: Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC), DEVICE: Ventriculoperitoneal Shunt
Hydrocephalus
Hydrocephalus, Infants, Ventriculoperitoneal Shunt, ETV+CPC, endoscopic third ventriculostomy, choroid plexus cauterization
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Show 21 locations
Study Locations
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| Location | Contacts |
|---|---|
| Alberta Children's Hospital Calgary, Alberta | Ruksana Rashid, MBBS MPH MSc - (rsrashid@ucalgary.ca) |
| Arnold Palmer Hospital for Children Orlando, Florida | Richard Guerrero - (richard.guerrero@orlandohealth.com) |
| British Columbia Children's Hospital Vancouver, British Columbia | Annika Weirs - (annika.weir@cw.bc.ca) |
| Children's Hospital Colorado Aurora, Colorado | Susan Staulcup, 80045 - (SUSAN.STAULCUP@UCDENVER.EDU) |
| Children's Hospital of Los Angeles Los Angeles, California | Helen Berroya - (hberroya@chla.usc.edu) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Kimberly Diamond, BS, BA - (diamondkl@upmc.edu) |
| Children's Of Alabama Birmingham, Alabama | Anastasia Smith, MPH - (Anastasia.Smith@childrensal.org) |
| Johns Hopkins Children's Center Baltimore, Maryland | Sydney White - (swhit128@jh.edu) |
| Monroe Carell Jr. Children's Hospital at Vanderbilt Nashville, Tennessee | Julia Loes - (julia.loes@vumc.org) Stephen Gannon - (stephen.r.gannon@vumc.org) |
| Nationwide Children's Hospital Columbus, Ohio | Jared Haught - (Jared.Haught@nationwidechildrens.org) |
| Phoenix Children's Hospital Phoenix, Arizona | Bethany Norton - (bnorton1@phoenixchildrens.com) |
| Primary Children's Hospital Salt Lake City, Utah | Alli Ludwick - (allison.ludwick@hsc.utah.edu) |
| Seattle Children's Hospital Seattle, Washington | Jessica Becerra - (Jessica.Becerra@seattlechildrens.org) |
| St. Louis Children's Hospital St Louis, Missouri | Diego Morales, MS - (moralesd@wudosis.wustl.edu) Mary Goldschmidt - (goldschmidt@wustl.edu) |
| Texas Children's Hospital Houston, Texas | Edgardo Santisbon - (exsantis@texaschildrens.org) |
| The Hospital for Sick Children Toronto, Ontario | Homa Ashrafpour - (homa.ashrafpour@sickkids.ca) |
| The Pennsylvania State University University Park, Pennsylvania | |
| Trustees of Indiana University Indianapolis, Indiana | Mariah Shirrell - (mkillin@iu.edu) |
| Virginia Commonwealth University Richmond, Virginia | |
| Wolfson Children's Hospital Jacksonville, Florida | Asmaa Hatem - (Asmaa.Hatem@jax.ufl.edu) |
| Yale University New Haven, Connecticut |
Effectiveness of the Eko Digital Stethoscope in Capturing Infant ECGs
Christopher Snyder - christopher.snyder@vcuhealth.org
NCT06382207
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Inclusion Criteria:
* Age \<1 year
* No previous diagnosis of arrhythmia
* Parent/caregiver can provide informed consent
* Parent/caregiver can speak and understand simple English
Exclusion Criteria:
* Age ≥ 1 year
* Patient has a pacemaker or implantable cardioverter defibrillator (ICD)
* Parent/caregiver is unwilling or unable to provide informed consent
* Parent/caregiver is unable to speak and understand English DEVICE: Eko Duo electronic stethoscope, DEVICE: CORE 500 electronic stethoscope
Tachyarrhythmia
Infant Tachyarrhythmia, Cardiac Rhythm, Digital Stethoscope
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Christopher Snyder - (christopher.snyder@vcuhealth.org) Margaret Lessard - (margaret.lessard@vcuhealth.org) |
A Research Study to Advance the CF Therapeutics Pipeline for People Without Modulators
Olena Boyarska - olena.boyarska@seattlechildrens.org
NCT06504589
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Consent
A. Written informed consent (and assent when applicable) obtained from participant or participant's legal guardian
B. Is willing and able to adhere to the study visit schedule and other protocol requirements
Demographics
A. ≥ 12 years of age at Visit 1
Medical History
A. For persons of child-bearing potential: must not be pregnant at Visit 1 or plan to get pregnant during the 12-month study period
Disease History
A. Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:
* Sweat chloride ≥ 60 mEq/liter by quantitative pilocarpine iontophoresis test (QPIT)
* Two well-characterized disease-causing pathogenic variants in the CFTR gene
or
* One well-characterized disease-causing mutation and a second CFTR variant (with variable or uncharacterized disease-causing potential) and sweat ≥ 30 mmol/liter with permission of the study sponsor-investigators
B. Clinically stable with no significant changes in health status within the 28 days prior to and including Visit 1
C. Does not have a history of lung transplantation
Concomitant Medications
A. Not genetically eligible for a CFTR modulator according to product label indications and/or No use of CFTR modulator for 28 days prior to Visit 1 with no intent to start or restart during the study period
B. No use of an investigational drug within 90 days prior to and including Visit 1
C. Not currently participating in an interventional drug or device trial. Participation in long-term safety follow-up studies (without redosing) and/or behavioral intervention trials is allowed.
D. No initiation of new chronic therapy (e.g., ibuprofen, azithromycin, inhaled tobramycin, Cayston®) within 28 days prior to and including Visit 1
E. No acute use of antibiotics (oral, inhaled or IV) or acute use of systemic corticosteroids for respiratory tract symptoms within 28 days prior to and including Visit 1
Cystic Fibrosis
ineligible and/or not taking CFTR modulators, People with CF
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| Location | Contacts |
|---|---|
| Adult Cystic Fibrosis Center at the University of Utah Salt Lake City, Utah | Kristyn Packer - (kristyn.packer@hsc.utah.edu) |
| Atrium Health Wake Forest Baptist Winston-Salem, North Carolina | Anna Pippins - (apippins@wakehealth.edu) |
| Augusta University Augusta, Georgia | Heidi Stapp - (hstapp@augusta.edu) |
| Baylor College of Medicine Houston, Texas | Tracy Mosely - (tlmosely@texaschildrens.org) |
| Billings Clinic Billings, Montana | Jerimiah Lysinger - (JLysinger@billingsclinic.org) |
| Boston Children's Hospital Boston, Massachusetts | Robert Fowler - (Robert.fowler@childrens.harvard.edu) |
| Central Florida Pulmonary Group Orlando, Florida | Desiree Serr - (dserr@cfpulmonary.com) |
| Children's Healthcare of Atlanta and Emory University Atlanta, Georgia | Ashleigh Streby - (ashleigh.streby@emory.edu) |
| Children's Hospital Colorado Aurora, Colorado | Mary Cross - (mary.cross@childrenscolorado.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Erin Donnelly - (Donnellye4@email.chop.edu) |
| Childrens Hospital Los Angeles Los Angeles, California | Carmen Reyes - (mareyes@chla.usc.edu) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Kelly Thornton - (Kelly.Thornton@cchmc.org) |
| Cleveland Clinic Cystic Fibrosis Program Cleveland, Ohio | Dave Weaver - (weaverd@ccf.org) |
| Cohen Children's Medical Center of New York New Hyde Park, New York | Susan Galvin - (sgalvin@northwell.edu) |
| Columbia University Cystic Fibrosis Program New York, New York | Emily DiMango - (ead3@cumc.columbia.edu) |
| Cook Children's Medical Center Fort Worth, Texas | Anna Reyes - (anna.reyes@cookchildrens.org) |
| Corewell Health Helen DeVos Grand Rapids, Michigan | Alicia Castillo Bahena - (alicia.castillobahena@corewellhealth.org) |
| Dayton Children's Hospital Dayton, Ohio | Amy Jones - (Jonesa11@childrensdayton.org) |
| Dell Children's Medical Center of Central Texas Austin, Texas | Kristina "Tina" Adrean - (Kadrean@ascension.org) |
| Hershey Medical Center Pennsylvania State University Hershey, Pennsylvania | Diane M Kitch - (dkitch@pennstatehealth.psu.edu) |
| Inova L.J. Murphy Pediatric CF Program Fairfax, Virginia | Colleen Mann - (colleen.mann@inova.org) |
| John Hopkins Hospital Baltimore, Maryland | Jeanne Pinto - (jpinto4@jh.edu) |
| Massachusetts General Hospital Boston, Massachusetts | Margot Hardcastle - (mhardcastle@mgh.harvard.edu) |
| Medical University of South Carolina Charleston, South Carolina | Ashley Warden - (jonesash@musc.edu) |
| Morristown Medical Center Morristown, New Jersey | Debra Connolly - (Debra.Connolly@atlantichealth.org) |
| National Jewish Health Denver, Colorado | Alix Wilson - (wilsona@njhealth.org) |
| Nationwide Children's Hospital Columbus, Ohio | Diana Gilmore - (Diana.Gilmore@nationwidechildrens.org) |
| New York Medical College at Westchester Medical Center Valhalla, New York | Zachary Messer - (Zachary_Messer@nymc.edu) |
| Northwestern University Chicago, Illinois | Rachel Nelson - (rachel.nelson@northwestern.edu) |
| Oregon Health & Sciences University Portland, Oregon | Jenna Bucher - (bucherj@ohsu.edu) |
| Phoenix Children's Hospital Phoenix, Arizona | Natalia Argel - (Nargel@phoenixchildrens.com) |
| Prisma Health Children's Hospital - Midlands Columbia, South Carolina | Veronica Lipscomb - (Veronica.Lipscomb@PrismaHealth.org) |
| Providence Medical Group, Cystic Fibrosis Clinic Spokane, Washington | Joan Milton - (joan.milton@providence.org) |
| Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center Cleveland, Ohio | Primary RC & Participant Contact General Contact - (RainbowCFResearch@UHhospitals.org) |
| Riley Hospital for Children Indianapolis, Indiana | Lisa Bendy - (lbendy@iupui.edu) |
| Saint Luke's Cystic Fibrosis Center of Idaho Boise, Idaho | Lejla Godusevic - (godusevl@slhs.org) |
| Seattle Children's Hospital Seattle, Washington | Sharon McNamara - (sharon.mcnamara@seattlechildrens.org) |
| Stanford University Medical Center Palo Alto, California | Jacquelyn Spano - (jmzirbes@stanford.edu) |
| Tampa General Hospital Tampa, Florida | Andrew Marino - (armarino@usf.edu) |
| The Children's Hospital Alabama, University of Alabama at Birmingham Birmingham, Alabama | Kathryn Monroe - (kathrynmonroe@uabmc.edu) |
| The Cystic Fibrosis Center of Western New York Buffalo, New York | Julianne Hergenroder - (jhergenroder@upa.chob.edu) |
| The Minnesota Cystic Fibrosis Center Minneapolis, Minnesota | CF Trials Contact University of Minnesota, Participant Contact - (cftrials@umn.edu) |
| Tucson Cystic Fibrosis Center Tucson, Arizona | Elizabeth Ryan - (elizabethryan@email.arizona.edu) |
| Tulane University Metairie, Louisiana | Adrienne Savant - (asavant1@tulane.edu) |
| University of Arkansas for Medical Sciences Little Rock, Arkansas | Kathleen Hicks - (HicksKathleenT@uams.edu) |
| University of California San Diego La Jolla, California | Jenna Mielke - (jmielke@health.ucsd.edu) |
| University of California, San Francisco - Adult Center San Francisco, California | Courtney Moreno - (Courtney.Moreno@ucsf.edu) |
| University of California, San Francisco - Peds Center San Francisco, California | Ngoc Ly - (Ngoc.Ly@ucsf.edu) |
| University of Florida Gainesville, Florida | Chrystal Bailey - (Cbailey1@peds.ufl.edu) |
| University of Kansas Medical Center Fairway, Kansas | Lawrence Scott - (lscott2@kumc.edu) |
| University of Kentucky Lexington, Kentucky | Chase Whitaker - (chase.whitaker@uky.edu) |
| University of Massachusetts Memorial Health Care Worcester, Massachusetts | Jaclyn Longtine - (Jaclyn.Longtine@umassmed.edu) |
| University of Miami Miami, Florida | Ylber (Ivan) Whitaker - (yiw2@miami.edu) |
| University of Michigan, Michigan Medicine Ann Arbor, Michigan | Dawn Kruse - (dmkruse@med.umich.edu) |
| University of Nebraska Medical Center Omaha, Nebraska | Michel Veit - (michel.veit@unmc.edu) |
| University of North Carolina at Chapel Hill Chapel Hill, North Carolina | Julie Goudy - (julie_goudy@med.unc.edu) |
| University of Pennsylvania Philadelphia, Pennsylvania | Melissa Molter - (melissa.molter@pennmedicine.upenn.edu) |
| University of Pittsburgh Medical Center Pittsburgh, Pennsylvania | Adrienne DeRicco - (adrienne.dericco2@upmc.edu) |
| University of Rochester Medical Center Strong Memorial Rochester, New York | Barb Johnson - (Barbara_Johnson@URMC.Rochester.edu) |
| University of Texas Southwestern Dallas, Texas | Ashley Keller - (Ashley.Keller@UTSouthwestern.edu) |
| University of Texas Southwestern / Children's Health Dallas, Texas | Keianna Brown - (Keianna.brown@utsouthwestern.edu) |
| University of Washington Medical Center Seattle, Washington | Lauren Bartlett - (lrejman@uw.edu) |
| University of Wisconsin Madison, Wisconsin | Melanie Nelson - (mnelson@pediatrics.wisc.edu) |
| Vanderbilt University Medical Center Nashville, Tennessee | Brijesh Patel - (brijesh.patel@vumc.org) |
| Virginia Commonwealth University Richmond, Virginia | Akilah Pierre-Louis - (akilah.pierrelouis1@vcuhealth.org) |
| Washington University School of Medicine St Louis, Missouri | Irma Bauer - (irmabauer@wustl.edu) |
| Wayne State University Harper University Hospital Detroit, Michigan | Debra Driscoll - (ddriscol@med.wayne.edu) |
| West Virginia University - Morgantown Morgantown, West Virginia | Tammy Clark - (tclark@hsc.wvu.edu) |
A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations
BMS Study Connect Contact Center www.BMSStudyConnect.com - Clinical.Trials@bms.com
NCT04094610
Show full eligibility criteria
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Key
• Documented genetic ROS1 point mutation, fusion, or amplification or NTRK1-3 fusion as identified by local testing in a Clinical Laboratory Improvement Amendments (CLIA) laboratory in the US or equivalently accredited diagnostic lab outside the United States (US) is required.
• Phase 1: Age \<12 years; Phase 2: Age 12- 25 years
• Prior cytotoxic chemotherapy is allowed.
• Prior immunotherapy is allowed.
• Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal to 1.
• All subjects must have measurable disease by RECIST v1.1 or Response Assessment in Neuro-Oncology (RANO) criteria at time of enrollment.
• Subjects with a primary CNS tumor or CNS metastases must be neurologically stable on a stable or decreasing dose of steroids for at least 7 days prior to enrollment.
• Subjects must have a Lansky (\< 16 years) or Karnofsky (≥ 16 years) score of at least 50.
• Life expectancy greater than or equal to 12 weeks, in the investigator's opinion.
• Adequate hematologic, renal and hepatic function. Phase 2
• Cohort Specific
• Subjects in Cohorts 1 and 2 must have prospectively confirmed measurable disease by BICR prior to enrollment. Key Exclusion Criteria (Phase 1 and Phase 2):
• Subjects with neuroblastoma with only bone marrow disease evaluable by bone marrow aspiration only.
• Major surgery within 14 days (2 weeks) of start of repotrectinib treatment. Central venous access (Broviac, Mediport, etc.) placement does not meet criteria for major surgery.
• Known active infections requiring ongoing treatment (bacterial, fungal, viral including HIV positivity).
• Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact drug absorption.
• Any of the following cardiac criteria: * Mean resting corrected QT interval (ECG interval measured from the onset of the QRS complex to the end of the T wave) for heart rate (QTc) \> 480 msec obtained from three ECGs, using the screening clinic ECG machine-derived QTc value * Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \> 250 msec) * Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome, or any concomitant medication known to prolong the QT interval
• Peripheral neuropathy of CTCAE ≥grade 2.
• Subjects being treated with or anticipating the need for treatment with strong CYP3A4 inhibitors or inducers.
• Any potential allergies to repotrectinib and/or its excipients.
Inclusion Criteria:
• Documented genetic ROS1 point mutation, fusion, or amplification or NTRK1-3 fusion as identified by local testing in a Clinical Laboratory Improvement Amendments (CLIA) laboratory in the US or equivalently accredited diagnostic lab outside the United States (US) is required.
• Phase 1: Age \<12 years; Phase 2: Age 12- 25 years
• Prior cytotoxic chemotherapy is allowed.
• Prior immunotherapy is allowed.
• Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal to 1.
• All subjects must have measurable disease by RECIST v1.1 or Response Assessment in Neuro-Oncology (RANO) criteria at time of enrollment.
• Subjects with a primary CNS tumor or CNS metastases must be neurologically stable on a stable or decreasing dose of steroids for at least 7 days prior to enrollment.
• Subjects must have a Lansky (\< 16 years) or Karnofsky (≥ 16 years) score of at least 50.
• Life expectancy greater than or equal to 12 weeks, in the investigator's opinion.
• Adequate hematologic, renal and hepatic function. Phase 2
Inclusion Criteria:
• Cohort Specific
Inclusion Criteria:
* Cohort 1: Subjects with NTRK fusion gene positive (NTRK+) advanced solid tumors (including primary CNS tumors), that are tropomyosin receptor kinase (TRK) TKI naïve;
* Cohort 2: subjects with NTRK+ advanced solid tumors (including primary CNS tumors), that are TRK TKI pre-treated;
* Cohort 3: subjects with advanced solid tumors with ROS1 gene fusions or other ROS1 aberrations (including amplifications and point mutations) with measurable disease.
• Subjects in Cohorts 1 and 2 must have prospectively confirmed measurable disease by BICR prior to enrollment. Key Exclusion Criteria (Phase 1 and Phase 2):
• Subjects with neuroblastoma with only bone marrow disease evaluable by bone marrow aspiration only.
• Major surgery within 14 days (2 weeks) of start of repotrectinib treatment. Central venous access (Broviac, Mediport, etc.) placement does not meet criteria for major surgery.
• Known active infections requiring ongoing treatment (bacterial, fungal, viral including HIV positivity).
• Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact drug absorption.
• Any of the following cardiac criteria: * Mean resting corrected QT interval (ECG interval measured from the onset of the QRS complex to the end of the T wave) for heart rate (QTc) \> 480 msec obtained from three ECGs, using the screening clinic ECG machine-derived QTc value * Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \> 250 msec) * Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome, or any concomitant medication known to prolong the QT interval
• Peripheral neuropathy of CTCAE ≥grade 2.
• Subjects being treated with or anticipating the need for treatment with strong CYP3A4 inhibitors or inducers.
• Any potential allergies to repotrectinib and/or its excipients.
DRUG: Oral repotrectinib (TPX-0005)
Locally Advanced Solid Tumors, Metastatic Solid Tumors, Lymphoma, Primary CNS Tumors
ALK, ROS1, NTRK1-3, Primary CNS tumor, anaplastic large cell lymphoma, metastatic solid tumor, advanced solid tumor, sarcoma, infantile fibrosarcoma, glioblastoma, soft tissue schwannoma, solitary fibrous tumor, glioma, inflammatory myofibroblastic tumor, pediatric
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Show 68 locations
Study Locations
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| Location | Contacts |
|---|---|
| Arnold Palmer Hospital for Children Orlando, Florida | |
| Asan Medical Center Seoul, | |
| Centre Hospitalier Universitaire d'Angers Angers, Pays de la Loire Region | |
| Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Pellegrin Bordeaux, | |
| Children's Health Queensland Hospital and Health Service South Brisbane, Queensland | |
| Children's Hospital Colorado - Anschutz Medical Campus Aurora, Colorado | |
| Children's Hospital Los Angeles Los Angeles, California | |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | |
| Children's Hospital of Richmond at VCU Richmond, Virginia | |
| Clinica Universidad de Navarra Madrid, | |
| Clinica Universidad de Navarra Madrid, | |
| Dana Farber Cancer Institute. Boston, Massachusetts | |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Milano, | |
| HM Sanchinarro University Hospital Madrid, | |
| Hospital Infantil Universitario Nino Jesus Madrid, | |
| Hospital Sant Joan de Deu Barcelona, | |
| Hospital Universitari Vall d'Hebron Barcelona, | |
| Hospital Universitario y Politécnico La Fe Valencia, | |
| Hôpitaux Universitaires de Marseille Timone Marseille, | |
| Institut Gustave-Roussy Villejuif, FR | |
| Institut d Hematologie et d Oncologie Pediatriques Lyon Cedex 08, | |
| KK Women's and Children's Hospital Singapore, | |
| Local Institution - 2110 New Brunswick, New Jersey | |
| Local Institution - 2112 Cleveland, Ohio | |
| Local Institution - 2118 Houston, Texas | |
| Local Institution - 2119 Atlanta, Georgia | |
| Local Institution - 2120 Orlando, Florida | |
| Local Institution - 2121 Charlotte, North Carolina | |
| Local Institution - 2203 Ottawa, Ontario | |
| Local Institution - 2205 Montreal, Quebec | |
| Local Institution - 4108 Sevilla, | |
| Local Institution - 4302 Rome, | |
| Local Institution - 4401 Cardiff, | |
| Local Institution - 4402 London, | |
| Local Institution - 4403 Birmingham, | |
| Local Institution - 4404 Liverpool, England | |
| Local Institution - 4405 London, | |
| Local Institution - 4406 Glasgow, | |
| Local Institution - 6103 Westmead, New South Wales | |
| Local Institution - 6104 Randwick, New South Wales | |
| Local Institution - 6105 Barcelona, | |
| Local Institution - 6106 Madrid, | |
| Local Institution - 6107 Valencia, | |
| Local Institution - 6108 Villejuif, | |
| Local Institution - 6109 Paris, | |
| Local Institution - 6110 Marseille Cedex 5, | |
| Local Institution - 6111 Lyon, Rhone | |
| Local Institution - 6112 Nantes, | |
| Local Institution - 6113 Padova, | |
| Local Institution - 6114 Torino, | |
| Maine Medical Center Portland, Maine | |
| Memorial Sloan-Kettering Cancer Center. New York, New York | |
| National Taiwan University Hospital Taipei, | |
| National University Hospital Singapore, | |
| Penn State Milton S. Hershey Medical Center Hershey, Pennsylvania | |
| Perth Childrens Hospital Nedlands, Western Australia | |
| Rigshospitalet - Glostrup Copenhagen, | |
| Samsung Medical Center Seoul, | |
| Seoul National University Hospital Seoul, Seoul Teugbyeolsi | |
| St. Jude Children's Research Hospital Memphis, Tennessee | |
| Stollery Children's Hospital Edmonton, Alberta | |
| Taipei Medical University Hospital Taipei, | |
| The University of Texas MD Anderson Cancer Center. Houston, Texas | |
| The University of Texas Southwestern Medical Center - Harold C Simmons Comprehensive Cancer Center Dallas, Texas | |
| University of Calgary Calgary, Alberta | |
| University of California at Los Angeles Los Angeles, California | |
| Washington University School of Medicine in St. Louis St Louis, Missouri | |
| Yonsei Universtidy Health System Seoul, Seodaemun-gu |