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27 Study Matches
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 101 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, | |
| CHRU de Nancy - Hôpitaux de Brabois Vandœuvre-lès-Nancy, | |
| CHU Bretonneau Tours, | |
| CHU Lyon Sud Pierre-Bénite, | |
| CHU de Nantes hotel Dieu Nantes, | |
| Carmel Medical Center Haifa, | |
| Centre Hospitalier Universitaire (CHU) de Bordeaux Hopital HautLeveque Centre Francois Magendie Pessac, | |
| China Medical University Hospital Taichung, | |
| City of Hope Duarte, California | |
| City of Hope Phoenix Goodyear, Arizona | |
| 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, | |
| Guys and St Thomas NHS Foundation Trust London, | |
| Hadassah University Hospita Ein Kerem Jerusalem, | |
| Henan Cancer Hospital Zhengzhou, | |
| Hokkaido University Hospital Sapporo, | |
| 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 Salvador, | |
| 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, | |
| 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, | |
| National Cheng Kung University Hospital Tainan, | |
| 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, | |
| 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, | |
| UCSF Benioff Children's Hospital San Francisco, California | |
| 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 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, |
Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy
Gwaltney, Lindsey - lbgwaltney@vcu.edu
Griffin, Jordyn
NCT03959085
HM20018568
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Inclusion Criteria:
* B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to eligibility studies (Part A) prior to treatment and enrollment on AALL1732. Note that central confirmation of MPAL diagnosis must occur within 22 days of enrollment for suspected MPAL patients. If not performed within this time frame, patients will be taken off protocol.
* APEC14B1 is not a requirement for B-LLy patients but for institutional compliance every patient should be offered participation in APEC14B1. B-LLy patients may directly enroll on AALL1732.
* Patients must be \> 365 days and \< 25 years of age
* White blood cell count (WBC) criteria for patients with B-ALL (within 7 days prior to the start of protocol-directed systemic therapy):
* Age 1-9.99 years: WBC \>= 50,000/uL
* Age 10-24.99 years: Any WBC
* Age 1-9.99 years: WBC \< 50,000/uL with:
* Testicular leukemia
* CNS leukemia (CNS3)
* Steroid pretreatment.
* White blood cell count (WBC) criteria for patients with MPAL (within 7 days prior to the start of protocol-directed systemic therapy):
* Age 1-24.99 years: any WBC NOTE: Patients enrolled as suspected MPAL but found on central confirmatory testing to have B-ALL must meet the B-ALL criteria above (age, WBC, extramedullary disease, steroid pretreatment) to switch to the B-ALL stratum before the end of induction.
* Patient has newly diagnosed B-ALL or MPAL (by World Health Organization \[WHO\] 2016 criteria) with \>= 25% blasts on a bone marrow (BM) aspirate;
* OR If a BM aspirate is not obtained or is not diagnostic of acute leukemia, the diagnosis can be established by a pathologic diagnosis of acute leukemia on a BM biopsy;
* OR A complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic cells if a bone marrow aspirate or biopsy cannot be performed.
* Patient has newly diagnosed B-LLy Murphy stages III or IV.
* Patient has newly diagnosed B-LLy Murphy stages I or II with steroid pretreatment.
* Note: For B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL. For tissue processed by other means (i.e., paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of B-LLy defined by the submitting institution will be accepted.
* Central nervous system (CNS) status must be determined prior to enrollment based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment and cytoreduction. It is recommended that intrathecal cytarabine be administered at the time of the diagnostic lumbar puncture. This is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture. This is allowed prior to enrollment. Systemic chemotherapy must begin within 72 hours of this intrathecal therapy.
* All patients and/or their parents or legal guardians must sign a written informed consent.
* All institutional, Food and Drug Administration (FDA), and NCI requirements for human studies must be met.
Exclusion Criteria:
* Patients with Down syndrome are not eligible (patients with Down syndrome and B-ALL are eligible for AALL1731, regardless of NCI risk group).
* With the exception of steroid pretreatment and steroid cytoreduction or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1732.
* Patients who have received \> 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy.
* Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrow submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted containing \> 1,000/uL circulating leukemia cells.
* Patients with acute undifferentiated leukemia (AUL) are not eligible.
* For Murphy stage III/IV B-LLy patients, or stage I/II patients with steroid pretreatment, the following additional exclusion criteria apply:
* T-lymphoblastic lymphoma.
* Morphologically unclassifiable lymphoma.
* Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma.
* Patients with known Charcot-Marie-Tooth disease.
* Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype.
* Patients requiring radiation at diagnosis.
* 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 women who plan to breastfeed their infants while on study and for 2 months after the last dose of inotuzumab ozogamicin.
* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of study participation. For those patients randomized to inotuzumab ozogamicin, there is a minimum of 8 months after the last dose of inotuzumab ozogamicin for females and 5 months after the last dose of inotuzumab ozogamicin for males. PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, PROCEDURE: Bone Scan, DRUG: Calaspargase Pegol, PROCEDURE: Computed Tomography, DRUG: Cyclophosphamide, DRUG: Cytarabine, DRUG: Daunorubicin Hydrochloride, DRUG: Dexamethasone, DRUG: Doxorubicin Hydrochloride, BIOLOGICAL: Inotuzumab Ozogamicin, DRUG: Leucovorin Calcium, PROCEDURE: Magnetic Resonance Imaging, DRUG: Mercaptopurine, DRUG: Methotrexate, DRUG: Pegaspargase, PROCEDURE: Positron Emission Tomography, DRUG: Prednisolone, OTHER: Questionnaire Administration, RADIATION: Radiation Therapy, RADIATION: Radiation Therapy, DRUG: Thioguanine, DRUG: Vincristine Sulfate
B Acute Lymphoblastic Leukemia, B Lymphoblastic Lymphoma, Central Nervous System Leukemia, Mixed Phenotype Acute Leukemia, Testicular Leukemia
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Show 230 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 | |
| Alberta Children's Hospital Calgary, Alberta | Site Public Contact - (research4kids@ucalgary.ca) |
| 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) |
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Banner Children's at Desert Mesa, Arizona | |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Baystate Medical Center Springfield, Massachusetts | Site Public Contact - (tamara.wrenn@baystatehealth.org) |
| Blank Children's Hospital Des Moines, Iowa | Site Public Contact - (samantha.mallory@unitypoint.org) |
| British Columbia Children's Hospital Vancouver, British Columbia | |
| 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) |
| 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) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Cedars Sinai Medical Center Los Angeles, California | |
| 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 - (COGResearchGroup@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 | |
| 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) |
| Driscoll Children's Hospital Corpus Christi, Texas | Site Public Contact - (Crystal.DeLosSantos@dchstx.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 | |
| Eastern Maine Medical Center Bangor, Maine | |
| Edwards Comprehensive Cancer Center Huntington, West Virginia | |
| 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) |
| HIMA San Pablo Oncologic Hospital Caguas, | |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Henry Ford Health Saint John Hospital Detroit, Michigan | |
| 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) |
| Inova Fairfax Hospital Falls Church, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Janeway Child Health Centre St. John's, Newfoundland and Labrador | Site Public Contact - (beverlyj.mitchell@easternhealth.ca) |
| Jersey Shore Medical Center Neptune City, New Jersey | |
| Jim Pattison Children's Hospital Saskatoon, Saskatchewan | Site Public Contact - (Jessica.Marien@saskhealthauthority.ca) |
| John Hunter Children's Hospital Hunter Regional Mail Centre, New South Wales | |
| Johns Hopkins All Children's Hospital St. Petersburg, Florida | Site Public Contact - (Ashley.Repp@jhmi.edu) |
| 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 | |
| Kingston Health Sciences Centre Kingston, Ontario | Site Public Contact - (cc-clinicaltrials@kgh.kari.net) |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | Site Public Contact - (CancerTrials@nyulangone.org) |
| Legacy Emanuel Children's Hospital Portland, Oregon | |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Loma Linda University Medical Center Loma Linda, California | |
| Loyola University Medical Center Maywood, Illinois | |
| Lucile Packard Children's Hospital Stanford University Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance, California | |
| 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 | |
| Maimonides Medical Center Brooklyn, New York | |
| Maine Children's Cancer Program Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Mary Bridge Children's Hospital and Health Center Tacoma, Washington | Site Public Contact - (research@multicare.org) |
| Massachusetts General Hospital Cancer Center Boston, Massachusetts | |
| Mattel Children's Hospital UCLA Los Angeles, California | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| McMaster Children's Hospital at Hamilton Health Sciences Hamilton, Ontario | |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| Medical City Dallas Hospital Dallas, Texas | |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Memorial Health University Medical Center Savannah, Georgia | Site Public Contact - (Lorraine.OHara@hcahealthcare.com) |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (OHR@mhs.net) |
| 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) |
| Miami Cancer Institute Miami, Florida | |
| Michigan State University East Lansing, Michigan | |
| Miller Children's and Women's Hospital Long Beach Long Beach, California | |
| Mission Hospital Asheville, North Carolina | Site Public Contact - (NCDV.ResearchRegulatory@HCAHealthcare.com) |
| Monash Medical Center-Clayton Campus Clayton, Victoria | |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Morristown Medical Center Morristown, New Jersey | |
| Mount Sinai Hospital New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| 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) |
| Natalie Warren Bryant Cancer Center at Saint Francis Tulsa, Oklahoma | |
| Nationwide Children's Hospital Columbus, Ohio | Site Public Contact - (Melinda.Triplet@nationwidechildrens.org) |
| Naval Medical Center - Portsmouth Portsmouth, Virginia | |
| Naval Medical Center -San Diego San Diego, California | |
| Nemours Children's Clinic - Pensacola Pensacola, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.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 Medicine Central DuPage Hospital Winfield, Illinois | Site Public Contact - (Claudine.Gamster@CadenceHealth.org) |
| 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) |
| Palms West Radiation Therapy Loxahatchee Groves, Florida | |
| Penn State Children's Hospital Hershey, Pennsylvania | |
| Perth Children's Hospital Perth, Western Australia | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Phoenix Childrens Hospital Phoenix, Arizona | |
| Presbyterian Hospital Albuquerque, New Mexico | Site Public Contact - (wburman@phs.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 Alaska Medical Center Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.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 | |
| Renown Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Rhode Island Hospital Providence, Rhode Island | |
| 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 | |
| Sacred Heart Hospital Pensacola, Florida | |
| 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 | |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Mary's Medical Center West Palm Beach, Florida | |
| Saint Peter's University Hospital New Brunswick, New Jersey | Site Public Contact - (kcovert@saintpetersuh.com) |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.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) |
| Santa Barbara Cottage Hospital Santa Barbara, California | |
| Saskatoon Cancer Centre Saskatoon, Saskatchewan | |
| Scott and White Memorial Hospital Temple, Texas | |
| Seattle Children's Hospital Seattle, Washington | |
| Sinai Hospital of Baltimore Baltimore, Maryland | |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Starship Children's Hospital Grafton, 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) |
| Sunrise Hospital and Medical Center Las Vegas, Nevada | |
| Sutter Medical Center Sacramento Sacramento, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| T C Thompson Children's Hospital Chattanooga, Tennessee | |
| Tampa General Hospital Tampa, Florida | Site Public Contact - (syapchanyk@tgh.org) |
| Texas Tech University Health Sciences Center-Amarillo Amarillo, Texas | |
| 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 | Site Public Contact - (info@thechildren.com) |
| The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York | |
| Tufts Children's Hospital Boston, Massachusetts | |
| UCSF Benioff Children's Hospital Oakland Oakland, California | Site Public Contact - (PedOncRschOAK@ucsf.edu) |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UF Health Cancer Institute - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| UMC Cancer Center / UMC Health System Lubbock, Texas | |
| UMass Memorial Medical Center - University Campus Worcester, Massachusetts | Site Public Contact - (cancer.research@umassmed.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 Medical Center of Southern Nevada Las Vegas, Nevada | |
| University Pediatric Hospital San Juan, | |
| University of Alberta Hospital Edmonton, Alberta | Site Public Contact - (pedsoncologyresearch@ahs.ca) |
| 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 Illinois Chicago, Illinois | |
| 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 Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Missouri Children's Hospital Columbia, Missouri | Site Public Contact - (snwq62@health.missouri.edu) |
| 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 Rochester Rochester, New York | |
| University of Texas Health Science Center at San Antonio San Antonio, Texas | Site Public Contact - (phoresearchoffice@uthscsa.edu) |
| University of Vermont and State Agricultural College Burlington, Vermont | Site Public Contact - (rpo@uvm.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 | |
| Vannie Cook Children's Clinic McAllen, Texas | Site Public Contact - (jrhartl1@txch.org) |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Walter Reed National Military Medical Center Bethesda, Maryland | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Wesley Medical Center Wichita, Kansas | Site Public Contact - (WesleyResearch@wesleymc.com) |
| West Virginia University Charleston Division Charleston, West Virginia | |
| West Virginia University Healthcare Morgantown, West Virginia | |
| Women's and Children's Hospital-Adelaide North Adelaide, South Australia | |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Multiplex Analysis of Venetoclax Sensitivity in Patients Diagnosed with AML or CLL
Lantis, Kristin - kllantis@vcu.edu
Grant, Steven
17581
HM20020962
Myeloid and Monocytic Leukemia, Lymphoid Leukemia
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Lantis, Kristin - (kllantis@vcu.edu) |
Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML (QuANTUM-WILD)
Daiichi Sankyo Contact for Clinical Trial Information - CTRinfo_us@daiichisankyo.com
NCT06578247
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Key
• Must be competent and able to comprehend, sign, and date an Ethics Committee (EC)- or Institutional Review Board (IRB)-approved ICF before performance of any trial-specific procedures or tests.
• ≥18 years or the minimum legal adult age (whichever is greater) and ≤70 years (at Screening).
• Newly diagnosed, morphologically documented primary AML based on the World Health Organization (WHO) 2016 classification (at Screening)
• Eastern Cooperative Oncology Group (ECOG) performance status (at the time the participant signs their ICF) of 0-2.
• Participant is a candidate for standard "7+3" induction chemotherapy regimen as specified in the protocol per investigator assessment Key
• Diagnosis of acute promyelocytic leukemia (APL), French-American-British classification M3 or WHO classification of APL with translocation, t(15;17)(q22;q12), or BCR-ABL positive leukemia (ie, chronic myelogenous leukemia in blast crisis); participants who undergo diagnostic workup for APL and treatment with all-trans retinoic acid (ATRA), but who are found not to have APL, are eligible (treatment with ATRA must be discontinued before starting induction chemotherapy).
• Diagnosis of AML secondary to prior chemotherapy or radiotherapy.
• Diagnosis of AML with known antecedent myelodysplastic syndrome (MDS) or a myeloproliferative neoplasm (MPN) or MDS/MPNs including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), juvenile myelomonocytic leukemia (JMML) and others.
• Participants with newly diagnosed AML with FLT3-ITD mutations (FLT3-ITD \[+\]) present at ≥5% VAF (or ≥0.05 SR) based on a validated FLT3 mutation assay.
• Prior treatment for AML, except for the following allowances prior to Day 1 of chemotherapy:
• Leukapheresis;
• Treatment for hyperleukocytosis with hydroxyurea;
• Cranial radiotherapy for central nervous system (CNS) leukostasis;
• Prophylactic intrathecal chemotherapy
Inclusion Criteria:
• Must be competent and able to comprehend, sign, and date an Ethics Committee (EC)- or Institutional Review Board (IRB)-approved ICF before performance of any trial-specific procedures or tests.
• ≥18 years or the minimum legal adult age (whichever is greater) and ≤70 years (at Screening).
• Newly diagnosed, morphologically documented primary AML based on the World Health Organization (WHO) 2016 classification (at Screening)
• Eastern Cooperative Oncology Group (ECOG) performance status (at the time the participant signs their ICF) of 0-2.
• Participant is a candidate for standard "7+3" induction chemotherapy regimen as specified in the protocol per investigator assessment Key
Exclusion Criteria:
• Diagnosis of acute promyelocytic leukemia (APL), French-American-British classification M3 or WHO classification of APL with translocation, t(15;17)(q22;q12), or BCR-ABL positive leukemia (ie, chronic myelogenous leukemia in blast crisis); participants who undergo diagnostic workup for APL and treatment with all-trans retinoic acid (ATRA), but who are found not to have APL, are eligible (treatment with ATRA must be discontinued before starting induction chemotherapy).
• Diagnosis of AML secondary to prior chemotherapy or radiotherapy.
• Diagnosis of AML with known antecedent myelodysplastic syndrome (MDS) or a myeloproliferative neoplasm (MPN) or MDS/MPNs including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), juvenile myelomonocytic leukemia (JMML) and others.
• Participants with newly diagnosed AML with FLT3-ITD mutations (FLT3-ITD \[+\]) present at ≥5% VAF (or ≥0.05 SR) based on a validated FLT3 mutation assay.
• Prior treatment for AML, except for the following allowances prior to Day 1 of chemotherapy:
• Leukapheresis;
• Treatment for hyperleukocytosis with hydroxyurea;
• Cranial radiotherapy for central nervous system (CNS) leukostasis;
• Prophylactic intrathecal chemotherapy
DRUG: Quizartinib, DRUG: Placebo, DRUG: Chemotherapy
Leukemia
acute myeloid leukemia, quizartinib, FLT3, FLT3-ITD, Chemotherapy, FLT3-WT
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Study Locations
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| Location | Contacts |
|---|---|
| 'Shathd' Ead Sofia Sofia, | |
| AZ Delta Roeselare, | |
| AZ Sint-Jan Bruges, | |
| Affiliated Hospital of Nantong University Nantong, | |
| Ajou University Hospital Gyeonggi-do, | |
| Akademiska Sjukhuset Uppsala, | |
| Akita University Hospital Akita, | |
| Aomori Prefetural Central Hospital Aomori, | |
| Asan Medical Center Seoul, | |
| Asst Dei Sette Laghi Ospedale Di Circolo E Fondazione Macchi Varese Varese, | |
| Augusta University Augusta, Georgia | |
| Azienda Ospedaliera Universitaria Policlinico Tor Vergata Rome, | |
| Azienda Ospedaliera Universitaria Policlinico Tor Vergata Rome, | |
| Azienda Ospedaliera Vincenzo Cervello Palermo, | |
| Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Bari, Apulia | |
| Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino Torino, | |
| Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda) Milan, | |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) Brescia, | |
| Box Hill Hospital Box Hill, | |
| CHU Amiens - Hopital Sud Salouël, | |
| CHU Nice - Hôpital de l'Archet 1 Nice, | |
| CHU de Caen Caen, | |
| CHU de Nantes - Hotel Dieu Nantes, | |
| Centre Hospitalier Lyon Sud Pierre BĂŠnite, | |
| Centre Hospitalier de Versailles Le Chesnay, | |
| Centre Leon Berard Lyon, | |
| Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria Lisbon, | |
| Centro de Hematologia E Hemoterapia - Hemocentro de Campinas - Unicamp Campinas, | |
| Centro de Hematologia E Hemoterapia - Hemocentro de Campinas - Unicamp Campinas, | |
| Cepon - Centro De Pesquisas Oncolagicas de Santa Catarina Florianópolis, | |
| Cetus Hospital Dia Oncologia Belo Horizonte, | |
| Chang Gung Memorial Hospital Kaohsiung City, | |
| Charite Campus Virchow-Klinikum Berlin, | |
| Chiba Aoba Municipal Hospital Chiba, | |
| China Medical University Hospital Taichung, | |
| Chonnam National University Hwasun Hospital Jeollanam-do, | |
| Chu Angers - Hă"Pital Hă"Tel Dieu Angers, | |
| Chu Rennes - Hopital Pontchaillou Rennes, | |
| Chu de Bordeaux - Hă"Pital Haut-Lă Vă Que Pessac, | |
| Chu de Grenoble - Hospital Albert Michallon La Tronche, | |
| Chu of Liège Liège, | |
| Chugoku Central Hospital Fukuyama, | |
| Churchill Hospital Oxford, | |
| City of Hope Phoenix Goodyear, Arizona | |
| Cleveland Clinic Taussig Cancer Center Cleveland, Ohio | |
| Clinica Universidad de Navarra Madrid, | |
| Clinical Hospital Centar Zagreb Zagreb, | |
| Clinical Hospital Centre Rijeka Rijeka, | |
| Clinical Hospital Dubrava Zagreb, | |
| Colorado Blood Cancer Institute Denver, Colorado | |
| Complejo Hospitalario Universitario de Albacete Albacete, | |
| Complejo Hospitalario Universitario de Santiago Santiago de Compostela, | |
| Concord Repatriation General Hospital Concord, New South Wales | |
| Curie Oncology Pte Ltd Singapore, | |
| Daegu Catholic University Medical Center Daegu, | |
| David Geffen School of Medicine Los Angeles, California | |
| Debreceni Egyetem Debrecen, | |
| Duke Cancer Institute - Sarcoma Research Durham, North Carolina | |
| Ehime Prefectural Central Hospital Matsuyama, | |
| Fakultni Nemocnice Ostrava Ostrava - Poruba, | |
| Fakultni nemocnice Brno Brno, | |
| Fakultni nemocnice Hradec Kralove Hradec Králové, | |
| Fakultni nemocnice Kralovske Vinohrady Prague, | |
| Fakultni nemocnice Plzen Pilsen, | |
| Fiona Stanley Hospital Murdoch, | |
| Flinders Medical Centre (Fmc) Bedford Park, | |
| Flinders Medical Centre (Fmc) Bedford Park, | |
| Florida Hospital Cancer Institute - Kissimmee Kissimmee, Florida | |
| Fondazione Policlinico Universitario Agostino Gemelli Irccs Roma, | |
| Fundaã§Ã£O Doutor Amaral Carvalho Jaú, | |
| Fundação Doutor Amaral Carvalho Jaú, | |
| Fundação Faculdade Regional de Medicina de São José do Rio Preto São José do Rio Preto, | |
| Gachon University Gil Medical Center Incheon, | |
| Gifu Municipal Hospital Gifu, | |
| Guangdong Provincial People's Hospital Guangzhou, | |
| Guangdong Provincial People's Hospital Guangzhou, | |
| Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz Győr, | |
| HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás Goiânia, | |
| HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará Fortaleza, | |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Hamamatsu University School of Medicine, University Hospital Hamamatsu, | |
| Hammersmith Hospital London, | |
| Hanusch Krankenhaus Der Wgkk Wien Vienna, | |
| Haukeland Universitetssykehus Bergen, | |
| Hc-Ufg - Hospital Das Clă Nicas Da Universidade Federal de Goiă S Goiânia, | |
| Henan Cancer Hospital Zhengzhou, | |
| Henry Ford Hospital Detroit, Michigan | |
| Hokkaido University Hospital Sapporo, | |
| Hopital Claude Huriez - Chru Lille Lille, | |
| Hopital de la Conception - APHM Marseille, | |
| Hospital Beneficencia Portuguesa da Sao Paulo São Paulo, | |
| Hospital Clinico Universitario de Salamanca Salamanca, | |
| Hospital Clinico Universitario de Valencia Valencia, | |
| Hospital De La Santa Creu I Sant Pau Barcelona, Catalunya [cataluña] | |
| Hospital Erasto Gaertner - Liga Paranaense de Combate Ao Că'Ncer Curitiba, | |
| Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer Curitiba, | |
| Hospital Ernesto Dornelles Porto Alegre, | |
| Hospital General Universitario Morales Meseguer Murcia, | |
| Hospital Nove de Julho São Paulo, | |
| Hospital Regional Universitario de Malaga Málaga, | |
| Hospital Saint-Louis Paris, | |
| Hospital San Pedro de Alcantara Cáceres, | |
| Hospital Universitari Son Espases Palma, | |
| Hospital Universitari Vall d'Hebron Barcelona, Barcelona [barcelona] | |
| Hospital Universitari i Politécnic La Fe Valencia, | |
| Hospital Universitario 12 de Octubre Madrid, | |
| Hospital Universitario Dr. Peset Valencia, | |
| Hospital Universitario Fundacion Jimenez Diaz Madrid, | |
| Hospital Universitario La Paz Madrid, Madrid, Comunidad de | |
| Hospital Universitario Marqués de Valdecilla Santander, | |
| Hospital Universitario Puerta de Hierro Majadahonda Majadahonda, | |
| Hospital Universitario Quironsalud Madrid Pozuelo de Alarcón, | |
| Hospital Universitario Reina Sofia Córdoba, Andalusia | |
| Hospital Universitario Virgen del Rocio Seville, | |
| Hospital Universitario de Burgos Burgos, | |
| Hospital Universitario de Gran Canaria Dr. Negrin Las Palmas, | |
| Hospital de Clinicas de Passo Fundo Passo Fundo, | |
| Hospital de Clă Nicas de Passo Fundo Passo Fundo, | |
| Hospital de Clă Nicas de Porto Alegre Porto Alegre, | |
| Houston Methodist Hospital Houston, Texas | |
| ICESP - INSTITUTO DO CANCER DO ESTADO DE SAO PAULO OCTAVIO FRIAS de OLIVEIRA SĂŁo Paulo, | |
| ICESP - INSTITUTO DO CANCER DO ESTADO DE SAO PAULO OCTAVIO FRIAS de OLIVEIRA SĂŁo Paulo, | |
| ICO Badalona - Hospital Universitari Germans Trias i Pujol Badalona, | |
| INCA - Instituto Nacional de Câncer Rio de Janeiro, | |
| IRCCS Ospedale Casa Sollievo della Sofferenza San Giovanni Rotondo, | |
| Inje University Haeundae Paik Hospital Busan, | |
| Inselspital - Universitaetsspital Bern Bern, | |
| Inselspital - Universitaetsspital Bern Bern, | |
| Institut Gustave Roussy Villejuif, | |
| Institut Jules Bordet Anderlecht, | |
| Institut Universitaire Du Cancer de Toulouse- Iuct-O Toulouse, | |
| Institut de Cancă Rologie de Strasbourg Europe - Icans Strasbourg, | |
| Institute of Hematology and Hospital of Blood Disease Tianjin, | |
| Instituto Português de Oncologia do Porto Francisco Gentil, EPE Porto, | |
| Institutul Clinic Fundeni Bucharest, | |
| Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj-Napoca, | |
| Instytut Hematologii I Transfuzjologii Warsaw, | |
| Irccs Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori 'Dino Amadori' - Irst Meldola, | |
| Istituto Clinico Humanitas Rozzano, | |
| Japan RED CROSS OSAKA HOSPITAL Osakar, | |
| Jeonbuk National University Hospital Jeonju, | |
| Johns Hopkins Hospital Baltimore, Maryland | |
| KRH Klinikum Siloah Hanover, | |
| Kanazawa University Hospital Kanazawa, | |
| Kaohsiung Chang Gung Memorial Hospital Kaohsiung City, | |
| King's College Hospital London, | |
| Klinika Hematoonkologii I Transplantacji Szpiku Lublin, | |
| Klinikum Aschaffenburg-Alzenau Alzenau in Unterfranken, | |
| Korea University Guro Hospital Seoul, Seoul-teukbyeolsi [seoul] | |
| Kyungpook National University Chilgok Hospital Daegu, | |
| Kyushu University Hospital Fukuoka, | |
| LKH - Universitätsklinikum der PMU Salzburg Salzburg, | |
| Liverpool Hospital Liverpool, | |
| London Health Sciences Centre London, | |
| Luzerner Kantonsspital - Luzern Lazern 16, | |
| Maidstone Hospital Maidstone, | |
| Manchester Royal Infirmary Manchester, | |
| Massachusetts General Hospital Boston, Massachusetts | |
| Mayo Clinic Jacksonville, Florida | |
| Mayo Clinic Jacksonville, Florida | |
| Mayo Clinic - Phoenix Phoenix, Arizona | |
| Mayo Clinic Hospital Jacksonville, Florida | |
| McGill University - Dept. Oncology Clinical Research Program Montreal, | |
| Md Anderson Cancer Centre Madrid, | |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Memorial Sloan Kettering Cancer Center - Main New York, New York | |
| Memorial Sloan Kettering Cancer Center - Main New York, New York | |
| Military Medical Academy Sofia, Sofia (stolitsa) | |
| Military Medical Academy - Mhat - Sofia Sofia, | |
| Moffitt Cancer Center Tampa, Florida | |
| Nagoya University Hospital Nagoya, | |
| National Cheng Kung University Hospitalx Tainan, | |
| National Hospital Organization Kumamoto Medical Center Kumamoto, | |
| National Taiwan University Hospital Taipei, | |
| National University Hospital Singapore, | |
| Ochsner Medical Center - New Orleans New Orleans, Louisiana | |
| Ohio Health Marion Area Physicians Columbus, Ohio | |
| Ordensklinikum Linz Gmbh - Elisabethinen Linz, | |
| Oregon Health & Science University (OHSU) Portland, Oregon | |
| Oslo University Hospital Oslo, | |
| Ospedale Maggiore di Novara Novara, | |
| Ospedale Mauriziano Umberto I Torino, | |
| Ospedale San Raffaele Milan, | |
| Peggy & Charles Stephenson Oklahoma Cancer Ctr Oklahoma City, Oklahoma | |
| Peking Union Medical College Hospital Beijing, | |
| Peking University First Hospital Beijing, | |
| Peking University Third Hospital Beijing, | |
| Princess Alexandra Hospital Woolloongabba, | |
| Princess Margaret Cancer Center Toronto, Ontario | |
| Pusan National University Hospital Busan, | |
| Qilu Hospital of Shandong University Jinan, | |
| Queen Elizabeth Hospital South Woodville, | |
| Rhode Island Hospital Providence, Rhode Island | |
| Robert H Lurie Comprehensive Cancer Center Northwestern University Chicago, Illinois | |
| Roswell Park Comprehensive Cancer Center Buffalo, New York | |
| Royal Adelaide Hospital Adelaide, South Australia | |
| Sahlgrenska Universitetssjukhuset Gothenburg, | |
| Saiseikai Maebashi Hospital Maebashi, | |
| Samsung Medical Center Seoul, | |
| Santa Casa de Misericordia de Porto Alegre Porto Alegre, Rio Grande do Sul | |
| Sapporo Hokuyu Hospital Sapporo, | |
| Saskatoon Cancer Centre Saskatoon, Saskatchewan | |
| Semmelweis Egyetem Budapest, | |
| Seoul National University Bundang Hospital Seongnam-si, | |
| Seoul National University Hospital Seoul, | |
| Severance Hospital, Yonsei University Health System Seoul, | |
| Shanghai Tongren Hospital Shanghai, | |
| Shengjing Hospital of China Medical University Shenyang, | |
| Shenzhen Second People'S Hospital Shenzhen, | |
| Sir Charles Gairdner Hospital Nedlands, | |
| Skă Nes Universitetssjukhus, Lund Lund, | |
| South Austin Medical Center Austin, Texas | |
| Spitalul Clinic Colentina Bucharest, | |
| Spitalul Clinic Coltea Bucharest, | |
| Spitalul Clinic Municipal Filantropia Craiova Craiova, | |
| Spzoz Msw Zwarmiĺsko-Mazurskimcen.Onko.Wolsztynie Olsztyn, | |
| St Vincent's Hospital Melbourne Darlinghurst, | |
| Staedtisches Klinikum Braunschweig Ggmbh Braunschweig, | |
| Stanford University School of Medicine- Parent Stanford, California | |
| Sun Yat-Sen University, Cancer Center Guangzhou, | |
| Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szeged, | |
| Sírio-Libanês Brasilia-Centro de Oncologia-Asa Sul São Paulo, | |
| Taipei Veterans General Hospital Taipei, | |
| Tampa General Hospital Tampa, Florida | |
| Tenri Hospital Tenri, | |
| Tesshokai Kameda General Hospital Kamogawa-shi, | |
| The Affiliated Hospital of Qingdao University Qingdao, | |
| The Alfred Hospital Melbourne, Victoria | |
| The Catholic University of Korea, Seoul St. Mary's Hospital Seoul, | |
| The Chinese University of Hong Kong (Cuhk) Shatin, | |
| The First Affiliated Hospital of Chongqing Medical University Chongqing, | |
| The First Affiliated Hospital of NanChang University Nanchang, | |
| The First Affiliated Hospital of Soochow University Suzhou, Jiangsu | |
| The First Affiliated Hospital of Wenzhou Medical University Wenzhou, | |
| The First Affiliated Hospital of Xiâ An Jiaotong University Xi'an, | |
| The James Cancer Hospital and Solove Research Institute Columbus, Ohio | |
| The Ottawa Hospital - General Campus Ottawa, | |
| The Second Hospital of Hebei Medicical University Shijiazhuang, | |
| The Second Xiangya Hospital of Central South University Changsha, | |
| The University of Chicago Medical Center Chicago, Illinois | |
| The University of Hong Kong Hong Kong, | |
| The University of Texas MD Anderson Cancer Center Houston, Texas | |
| Thomas Jefferson Univ Hosp Philadelphia, Pennsylvania | |
| Tianjin Medical University General Hospital Tianjin, | |
| Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Bunkyō City, | |
| Torbay Hospital Torquay, | |
| Townsville University Hospital Douglas, | |
| Tristar Bone Marrow Transplant Nashville, Tennessee | |
| UMHAT 'Dr. Georgi Stranski', EAD Pleven, | |
| UPMC Hillman Cancer Center Pittsburgh, Pennsylvania | |
| UZ Leuven Leuven, | |
| Ucsf - School of Medicine San Francisco, California | |
| Ulsan University Hospital Ulsan, | |
| Umhat 'Sv. Georgi', Ead Plovdiv, | |
| Umhat Prof. Dr. Stoyan Kirkovich Ad Stara Zagora, | |
| Umhat  Sv. Ivan Rilskiâ , Ead Sofia, | |
| Unesp - Faculdade de Medicina Da Universidade Estadual Paulista - Campus Botucatu Botucatu, | |
| UniversitaetsKlinikum Heidelberg Heidelberg, | |
| UniversitaetsKlinikum Heidelberg Heidelberg, | |
| Universitaetsklinikum Carl Gustav Carus TU Dresden Dresden, | |
| Universitaetsklinikum Essen Essen, | |
| Universitaetsklinikum Muenster Münster, | |
| Universitaetsklinikum Muenster Münster, | |
| Universitaetsklinikum Schleswig-Holstein Lübeck, | |
| University Clinical Center Nis Niš, | |
| University Clinical Center of Serbia Belgrade, | |
| University Hospital of North Norway Tromsø, | |
| University of Arizona Cancer Center Tucson, Arizona | |
| University of California Davis Health System Sacramento, California | |
| University of Cincinnati Cincinnati, Ohio | |
| University of Illinois Hospital & Health Sciences System Chicago, Illinois | |
| University of Kentucky Lexington, Kentucky | |
| University of Michigan Comprehensive Cancer Center Michigan Medicine Ann Arbor, Michigan | |
| University of Minnesota Medical School - Twin Cities Campus Minneapolis, Minnesota | |
| University of North Carolina Hospitals Chapel Hill, North Carolina | |
| University of Pennsylvania Philadelphia, Pennsylvania | |
| Universită"Tsklinikum Leipzig Klinik Fă R Hă"Matologie Internistische Onkologie Hă"Mostaseol Leipzig, | |
| Upstate University Hospital Syracuse, New York | |
| Ustav hematologie a krevni transfuze Prague, | |
| Uva Health System Charlottesville, Virginia | |
| Virginia Commonwealth University (VCU) Massey Cancer Center Richmond, Virginia | |
| Washington University St Louis, Missouri | |
| Winship Cancer Institute of Emory University Atlanta, Georgia | |
| Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu Torun, | |
| Wuxi People's Hospital Wuxi, Jiangsu | |
| Xiangya Hospital, Central South University Changsha, | |
| Yale University New Haven, Connecticut | |
| Yantai Yuhuangding Hospital Yantai, | |
| Yeungnam University Hospital Daegu, | |
| ZNA Antwerp, | |
| Zhong Da Hospital, Southeast University Nanjing, | |
| the First Hospital of Jilin University Changchun, |
The Pediatric Acute Leukemia (PedAL) Screening Trial - A Study to Test Bone Marrow and Blood in Children With Leukemia That Has Come Back After Treatment or Is Difficult to Treat - A Leukemia & Lymphoma Society and Children's Oncology Group Study
ctrrecruit@vcu.edu
NCT04726241
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Inclusion Criteria:
* Patients must be less than 22 years of age at the time of study enrollment
* Patient must have one of the following at the time of study enrollment:
* Patient has known or suspected relapsed/refractory (including primary refractory) AML as defined in protocol
* This includes isolated myeloid sarcoma
* Patient has known or suspected relapsed/refractory (including primary refractory) myeloid leukemia of Down syndrome (ML-DS)
* Patient has known or suspected relapsed ALL as defined in protocol that meets one of the following criteria:
* Second or greater B-ALL medullary relapse, excluding KMT2Ar
* Any first or greater B-ALL medullary relapse involving KMT2Ar
* Any first or greater T-ALL medullary relapse with or without KMT2Ar
* Patient has known or suspected relapsed/refractory (including primary refractory) mixed phenotype acute leukemia (MPAL) as defined in protocol
* Patient has known or suspected de novo or relapsed/refractory (including primary refractory) treatment-related AML (t-AML)
* Patient has known or suspected de novo or relapsed/refractory (including primary refractory) myelodysplastic syndrome (MDS) or treatment-related myelodysplastic syndrome (t-MDS)
* Note: Relapsed/refractory disease includes stable disease, progressive disease, and disease relapse.
* Patient has known or suspected de novo or relapsed/refractory (including primary refractory) juvenile myelomonocytic leukemia (JMML)
* Note: Relapsed/refractory disease includes stable disease, progressive disease, and disease relapse.
* 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
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Acute Myeloid Leukemia Post Cytotoxic Therapy, Juvenile Myelomonocytic Leukemia, Mixed Phenotype Acute Leukemia, Myelodysplastic Syndrome, Myelodysplastic Syndrome Post Cytotoxic Therapy, Myeloid Leukemia Associated With Down Syndrome
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See this study on ClinicalTrials.gov
Show 182 locations
Study Locations
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| Location | Contacts |
|---|---|
| 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 | |
| Alberta Children's Hospital Calgary, Alberta | Site Public Contact - (research4kids@ucalgary.ca) |
| 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) |
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Banner Children's at Desert Mesa, Arizona | |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| 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) |
| British Columbia Children's Hospital Vancouver, British Columbia | |
| 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) |
| 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) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| 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 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 - (COGResearchGroup@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) |
| Cleveland Clinic Foundation Cleveland, Ohio | |
| 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) |
| Driscoll Children's Hospital Corpus Christi, Texas | Site Public Contact - (Crystal.DeLosSantos@dchstx.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 | |
| Eastern Maine Medical Center Bangor, Maine | |
| 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) |
| HIMA San Pablo Oncologic Hospital Caguas, | |
| 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) |
| Inova Fairfax Hospital Falls Church, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Jersey Shore Medical Center Neptune City, New Jersey | |
| Johns Hopkins All Children's Hospital St. Petersburg, Florida | Site Public Contact - (Ashley.Repp@jhmi.edu) |
| 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 | |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | Site Public Contact - (CancerTrials@nyulangone.org) |
| Legacy Emanuel Children's Hospital Portland, Oregon | |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Loma Linda University Medical Center Loma Linda, California | |
| Loyola University Medical Center Maywood, Illinois | |
| 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) |
| Maimonides Medical Center Brooklyn, New York | |
| Maine Children's Cancer Program Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Mary Bridge Children's Hospital and Health Center Tacoma, Washington | Site Public Contact - (research@multicare.org) |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| Medical City Dallas Hospital Dallas, Texas | |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Memorial Health University Medical Center Savannah, Georgia | Site Public Contact - (Lorraine.OHara@hcahealthcare.com) |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (OHR@mhs.net) |
| 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 | |
| Miller Children's and Women's Hospital Long Beach Long Beach, California | |
| 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) |
| 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) |
| 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 - Pensacola Pensacola, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.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 | |
| 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) |
| Phoenix Childrens Hospital Phoenix, Arizona | |
| 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 Alaska Medical Center Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.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 | |
| Renown Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Rhode Island Hospital Providence, Rhode Island | |
| 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) |
| 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 | |
| Sacred Heart Hospital Pensacola, Florida | |
| 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 Children's Research Hospital Memphis, Tennessee | Site Public Contact - (referralinfo@stjude.org) |
| Saint Jude Midwest Affiliate Peoria, Illinois | |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Mary's Medical Center West Palm Beach, Florida | |
| 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 | |
| Starship Children's Hospital Grafton, 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) |
| 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 | Site Public Contact - (info@thechildren.com) |
| 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 - (PedOncRschOAK@ucsf.edu) |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UF Health Cancer Institute - Gainesville Gainesville, Florida | |
| UMC Cancer Center / UMC Health System Lubbock, Texas | |
| 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 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 Illinois Chicago, Illinois | |
| 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 Missouri Children's Hospital Columbia, Missouri | Site Public Contact - (snwq62@health.missouri.edu) |
| 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 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 | Kenneth B. De Santes - (kbdesantes@pediatrics.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 | |
| Walter Reed National Military Medical Center Bethesda, Maryland | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| West Virginia University Healthcare Morgantown, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia
ctrrecruit@vcu.edu
NCT06317662
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Inclusion Criteria:
* All patients must be enrolled on APEC14B1 and consented to eligibility screening (part A) prior to treatment and enrollment on AALL2321
* Infants (aged 365 days or less) on the date of diagnosis are eligible; infants must be \> 36 weeks gestational age at the time of enrollment
* Patients must have newly diagnosed B-acute lymphoblastic leukemia (B-ALL, 2017 World Health Organization \[WHO\] classification), also termed B-precursor ALL, or acute leukemia of ambiguous lineage (ALAL), which includes mixed phenotype acute leukemia. For patients with ALAL, the immunophenotype of the leukemia must comprise at least 50% B lineage
* Diagnostic immunophenotype: Leukemia cells must express CD19
Exclusion Criteria:
* Patients with Down Syndrome
* Patients with secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy
* Patients must not have received any cytotoxic chemotherapy for either the current diagnosis of infant ALL or for any cancer diagnosis prior to the initiation of protocol therapy, with the exception of:
* Steroid pretreatment:
* PredniSONE, prednisoLONE, or methylPREDNISolone for ≤ 72 hours (3 days) in the 7 days prior to enrollment. The dose of predniSONE, prednisoLONE or methylPREDNISolone does not affect eligibility
* Inhaled and topical steroids are not considered pretreatment
* Note: Pretreatment with dexamethasone in the 28 days prior to initiation of protocol therapy is not allowed with the exception of a single dose of dexamethasone used during or within 6 hours prior to or after sedation to prevent or treat airway edema. However, prior exposure to ANY steroids that occurred \> 28 days before enrollment does not affect eligibility
* Intrathecal cytarabine or methotrexate:
* An intrathecal dose of cytarabine or methotrexate in the 7 days prior to enrollment does not affect eligibility
* Note: The preference is to defer the diagnostic lumbar puncture with intrathecal chemotherapy to day 1 of induction to allow for cytoreduction of circulating blasts and decrease the potential for central nervous system (CNS) contamination due to a traumatic tap. If done prior to day 1 of induction, these results will be used to determine CNS status
* Hydroxyurea:
* Pretreatment with ≤ 72 hours (3 days) of hydroxyurea in the 7 days prior to enrollment does not affect eligibility
* 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 DRUG: Asparaginase Erwinia chrysanthemi, PROCEDURE: Biospecimen Collection, BIOLOGICAL: Blinatumomab, PROCEDURE: Bone Marrow Aspiration, DRUG: Calaspargase Pegol, PROCEDURE: Computed Tomography, DRUG: Cyclophosphamide, DRUG: Cytarabine, DRUG: Daunorubicin, DRUG: Dexamethasone, DRUG: Doxorubicin, PROCEDURE: Echocardiography Test, PROCEDURE: FDG-Positron Emission Tomography, DRUG: Leucovorin, DRUG: Levoleucovorin, PROCEDURE: Lumbar Puncture, PROCEDURE: Magnetic Resonance Imaging, DRUG: Mercaptopurine, DRUG: Methotrexate, DRUG: Methylprednisolone, PROCEDURE: Multigated Acquisition Scan, DRUG: Prednisolone, DRUG: Prednisone, DRUG: Therapeutic Hydrocortisone, DRUG: Thioguanine, DRUG: Venetoclax, DRUG: Vincristine
Acute Leukemia of Ambiguous Lineage, B Acute Lymphoblastic Leukemia
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Show 95 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) |
| 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) |
| Banner Children's at Desert Mesa, Arizona | |
| 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 | |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| 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 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 | 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 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 Mercy Hospitals and Clinics Kansas City, Missouri | Site Public Contact - (COGResearchGroup@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 | |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| 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) |
| Driscoll Children's Hospital Corpus Christi, Texas | Site Public Contact - (Crystal.DeLosSantos@dchstx.org) |
| 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) |
| Hackensack University Medical Center Hackensack, New Jersey | |
| 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) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | Site Public Contact - (CancerTrials@nyulangone.org) |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Loma Linda University Medical Center Loma Linda, California | |
| Lurie Children's Hospital-Chicago Chicago, Illinois | |
| Maine Children's Cancer Program Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Medical City Dallas Hospital Dallas, Texas | |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (OHR@mhs.net) |
| 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) |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Morristown Medical Center Morristown, New Jersey | |
| NYP/Weill Cornell Medical Center New York, New York | |
| Nemours Children's Clinic - Pensacola Pensacola, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.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 | |
| Norton Children's Hospital Louisville, Kentucky | Site Public Contact - (CancerResource@nortonhealthcare.org) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| 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 Alaska Medical Center Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington | Site Public Contact - (HopeBeginsHere@providence.org) |
| 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) |
| 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 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 Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.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 | |
| The Children's Hospital at TriStar Centennial Nashville, Tennessee | |
| UF Health Cancer Institute - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| 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 Pediatric Hospital San Juan, | |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Rochester Rochester, New York | |
| 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) |
| 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) |
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 223 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) |
| 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) |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Beacon Kalamazoo Kalamazoo, Michigan | |
| 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) |
| C S Mott Children's Hospital Ann Arbor, Michigan | |
| Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan | Site Public Contact - (connie.szczepanek@crcwm.org) |
| Carilion Children's Roanoke, Virginia | Site Public Contact - (wpmccarty@carilionclinic.org) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Carson Tahoe Regional Medical Center Carson City, Nevada | Site Public Contact - (research@sncrf.org) |
| 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 and Medical Center of Omaha Omaha, Nebraska | |
| Children's Hospital at Montefiore The Bronx, New York | Site Public Contact - (aaraiza@montefiore.org) |
| 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 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 Mercy Hospitals and Clinics Kansas City, Missouri | Site Public Contact - (COGResearchGroup@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 Comprehensive Cancer Center Duarte, California | Site Public Contact - (becomingapatient@coh.org) |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.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) |
| Cook Children's Medical Center Fort Worth, Texas | Site Public Contact - (CookChildrensResearch@cookchildrens.org) |
| 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 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) |
| Covenant Children's Hospital Lubbock, Texas | Site Public Contact - (mbisbee@providence.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) |
| Driscoll Children's Hospital Corpus Christi, Texas | Site Public Contact - (Crystal.DeLosSantos@dchstx.org) |
| 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 | |
| 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) |
| Hospital for Sick Children Toronto, Ontario | |
| IWK Health Centre Halifax, Nova Scotia | Site Public Contact - (Research@iwk.nshealth.ca) |
| Inova Fairfax Hospital Falls Church, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Jersey Shore Medical Center Neptune City, New Jersey | |
| Johns Hopkins All Children's Hospital St. Petersburg, Florida | Site Public Contact - (Ashley.Repp@jhmi.edu) |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kaiser Permanente Downey Medical Center Downey, California | |
| Kaiser Permanente Los Angeles Medical Center Los Angeles, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Anaheim Anaheim, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Bellflower Bellflower, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Fontana Fontana, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-San Diego Mission San Diego, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-San Diego Zion San Diego, California | Site Public Contact - (clinical.trials@kp.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Kingman Regional Medical Center Kingman, Arizona | 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) |
| 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) |
| 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 | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Mary Bridge Children's Hospital and Health Center Tacoma, Washington | Site Public Contact - (research@multicare.org) |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| Medical City Dallas Hospital Dallas, Texas | |
| Memorial Health University Medical Center Savannah, Georgia | Site Public Contact - (Lorraine.OHara@hcahealthcare.com) |
| 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) |
| Miami Cancer Institute Miami, Florida | |
| Michigan State University East Lansing, Michigan | |
| 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) |
| 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) |
| Munson Medical Center Traverse City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| NYP/Weill Cornell Medical Center New York, New York | |
| NYU Langone Hospital - Long Island Mineola, New York | Site Public Contact - (cancertrials@nyulangone.org) |
| Natalie Warren Bryant Cancer Center at Saint Francis Tulsa, Oklahoma | |
| Nationwide Children's Hospital Columbus, Ohio | Site Public Contact - (Melinda.Triplet@nationwidechildrens.org) |
| Nemours Children's Clinic - Pensacola Pensacola, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.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 | |
| North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington | Site Public Contact - (Memorial-ClinicalTrials@yvmh.org) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| Norton Children's Hospital Louisville, Kentucky | Site Public Contact - (CancerResource@nortonhealthcare.org) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Oncology Las Vegas - Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Oncology Las Vegas - Tenaya Las Vegas, Nevada | Site Public Contact - (research@sncrf.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) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| PCR Oncology Arroyo Grande, California | Site Public Contact - (research@sncrf.org) |
| Penn State Children's Hospital Hershey, Pennsylvania | |
| Phoenix Childrens Hospital Phoenix, Arizona | |
| Presbyterian Hospital Albuquerque, New Mexico | Site Public Contact - (wburman@phs.org) |
| Prisma Health Cancer Institute - Eastside Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Greenville Memorial Hospital Greenville, 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 Alaska Medical Center Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington | Site Public Contact - (HopeBeginsHere@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) |
| Rainbow Babies and Childrens Hospital Cleveland, Ohio | |
| Renown Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| 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) |
| Sacred Heart Hospital Pensacola, Florida | |
| Saint Francis Cancer Center Greenville, South Carolina | Site Public Contact - (Heather_Rich@bshsi.org) |
| Saint Francis Hospital Federal Way, Washington | 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 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's Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.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 | |
| Sinai Hospital of Baltimore Baltimore, Maryland | |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Stanford Cancer Institute Palo Alto Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| Stony Brook University Medical Center Stony Brook, New York | |
| 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) |
| Sutter Medical Center Sacramento Sacramento, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Tampa General Hospital Tampa, Florida | Site Public Contact - (syapchanyk@tgh.org) |
| 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 | |
| Trinity Health Grand Rapids Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Trinity Health Muskegon Hospital Muskegon, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| UCSF Benioff Children's Hospital Oakland Oakland, California | Site Public Contact - (PedOncRschOAK@ucsf.edu) |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UF Health Cancer Institute - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| UMC Cancer Center / UMC Health System Lubbock, Texas | |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University Medical Center of Southern Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| 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 Illinois Chicago, Illinois | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kansas Cancer Center Kansas City, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan | Site Public Contact - (slusserb@med.umich.edu) |
| University of Michigan Health - West Wyoming, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| University of Mississippi Medical Center Jackson, Mississippi | |
| 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 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 - 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) |
| 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 Children's Hospital Madera, California | Site Public Contact - (Research@valleychildrens.org) |
| Valley Medical Center Renton, Washington | Site Public Contact - (research@valleymed.org) |
| 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) |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| West Michigan Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations
Gwaltney, Lindsey - lbgwaltney@vcu.edu
Griffin, Jordyn
NCT04293562
HM20020887
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Inclusion Criteria:
* All patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part A) prior to enrollment and treatment on AAML1831
* Patients must be less than 22 years of age at the time of study enrollment
* Patient must be newly diagnosed with de novo AML according to the 2016 World Health Organization (WHO) classification with or without extramedullary disease
* Patient must have 1 of the following:
* \>= 20% bone marrow blasts (obtained within 14 days prior to enrollment)
* In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy
* \< 20% bone marrow blasts with one or more of the genetic abnormalities associated with childhood/young adult AML as provided in the protocol (sample obtained within 14 days prior to enrollment)
* A complete blood count (CBC) documenting the presence of at least 1,000/uL (i.e., a white blood cell \[WBC\] count \>= 10,000/uL with \>= 10% blasts or a WBC count of \>= 5,000/uL with \>= 20% blasts) circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed within 7 days prior to enrollment)
* ARM C: Patient must be \>= 2 years of age at the time of Late Callback
* ARM C: Patient must have FLT3/ITD allelic ratio \> 0.1 as reported by Molecular Oncology
* ARM C: Patient does not have any congenital long QT syndrome or congenital heart block
* ARM C: Females of reproductive potential must agree to use effective contraception during treatment and for at least 6 months after the last dose of gilteritinib
* ARM C: Lactating women must agree not to breastfeed during treatment with gilteritinib and for 2 months after the last dose of gilteritinib
* ARM C: Males of reproductive potential must agree to use effective contraception during treatment and for at least 4 months after the last dose of gilteritinib
* ARM D: Patient must be \>= 2 years of age at the time of Late Callback
* ARM D: Patient must have one of the clinically relevant non-ITD FLT3 activating mutations as reported by Foundation Medicine
* ARM D: Females of reproductive potential must agree to use effective contraception during treatment and for at least 6 months after the last dose of gilteritinib
* ARM D: Lactating women must agree not to breastfeed during treatment with gilteritinib and for 2 months after the last dose of gilteritinib
* ARM D: Males of reproductive potential must agree to use effective contraception during treatment and for at least 4 months after the last dose of gilteritinib
* NEUROPSYCHOLOGICAL TESTING: Patient must be enrolled on Arm A or Arm B. Patients who transfer to Arm C or Arm D are not eligible
* NEUROPSYCHOLOGICAL TESTING: Patient must be 5 years or older at the time of enrollment
* NEUROPSYCHOLOGICAL TESTING: English-, French- or Spanish-speaking
* NEUROPSYCHOLOGICAL TESTING: No known history of neurodevelopmental disorder prior to diagnosis of AML (e.g., Down syndrome, fragile X, William syndrome, mental retardation)
* NEUROPSYCHOLOGICAL TESTING: No significant visual or motor impairment that would prevent computer use or recognition of visual test stimuli
* 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:
* Fanconi anemia
* Shwachman Diamond syndrome
* Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21
* Telomere disorders
* Germline predispositions known, or suspected by the treating physician to increase risk of toxicity with AML therapy
* Any concurrent malignancy
* Juvenile myelomonocytic leukemia (JMML)
* Philadelphia chromosome positive AML
* Mixed phenotype acute leukemia
* Acute promyelocytic leukemia
* Acute myeloid leukemia arising from myelodysplasia
* Therapy-related myeloid neoplasms
* Patients with persistent cardiac dysfunction prior to enrollment, defined as ejection fraction (EF) \< 50% (preferred method Biplane Simpson's EF) or if EF unavailable, shortening fraction (SF) \< 24%. \*Note: if clinically safe and feasible, repeat echocardiogram is strongly advised in order to confirm cardiac dysfunction following clinical stabilization, particularly if occurring in the setting of sepsis or other transient physiologic stressor. If the repeat echocardiogram demonstrates an EF \>= 50%, the patient is eligible to enroll and may receive an anthracycline-containing Induction regimen
* Administration of prior anti-cancer therapy except as outlined below:
* Hydroxyurea
* All-trans retinoic acid (ATRA)
* Corticosteroids (any route)
* Intrathecal therapy given at diagnosis
* In particular, strong inducers of CYP3A4 and/or P-glycoprotein (P-gp) should be avoided from the time of enrollment until it is determined whether the patient will receive gilteritinib. Patients receiving gilteritinib will be required to avoid strong CYP3A4 inducers and/or strong P-gp inducers for the duration of the study treatment
* 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
* ARM D: Patient does not have any congenital long QT syndrome or congenital heart block PROCEDURE: Allogeneic Hematopoietic Stem Cell Transplantation, DRUG: Asparaginase Erwinia chrysanthemi, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, PROCEDURE: Computed Tomography, DRUG: Cytarabine, DRUG: Daunorubicin Hydrochloride, DRUG: Dexrazoxane Hydrochloride, DRUG: Etoposide, OTHER: Fludeoxyglucose F-18, DRUG: Gemtuzumab Ozogamicin, DRUG: Gilteritinib Fumarate, DRUG: Liposome-encapsulated Daunorubicin-Cytarabine, PROCEDURE: Magnetic Resonance Imaging, DRUG: Methotrexate, DRUG: Mitoxantrone Hydrochloride, PROCEDURE: Positron Emission Tomography, OTHER: Questionnaire Administration, DRUG: Therapeutic Hydrocortisone
Acute Myeloid Leukemia
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See this study on ClinicalTrials.gov
Show 205 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 | |
| Alberta Children's Hospital Calgary, Alberta | Site Public Contact - (research4kids@ucalgary.ca) |
| 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) |
| 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) |
| Banner Children's at Desert Mesa, Arizona | |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| 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) |
| British Columbia Children's Hospital Vancouver, British Columbia | |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Broward Health Medical Center Fort Lauderdale, Florida | |
| 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) |
| 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) |
| 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 - (COGResearchGroup@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 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) |
| 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) |
| Driscoll Children's Hospital Corpus Christi, Texas | Site Public Contact - (Crystal.DeLosSantos@dchstx.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 | |
| Eastern Maine Medical Center Bangor, Maine | |
| 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 | |
| Henry Ford Health Saint John Hospital Detroit, Michigan | |
| 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) |
| Inova Fairfax Hospital Falls Church, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Jim Pattison Children's Hospital Saskatoon, Saskatchewan | Site Public Contact - (Jessica.Marien@saskhealthauthority.ca) |
| Johns Hopkins All Children's Hospital St. Petersburg, Florida | Site Public Contact - (Ashley.Repp@jhmi.edu) |
| 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 | |
| Kingston Health Sciences Centre Kingston, Ontario | Site Public Contact - (cc-clinicaltrials@kgh.kari.net) |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | Site Public Contact - (CancerTrials@nyulangone.org) |
| Legacy Emanuel Children's Hospital Portland, Oregon | |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Loma Linda University Medical Center Loma Linda, California | |
| Loyola University Medical Center Maywood, Illinois | |
| 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) |
| Maimonides Medical Center Brooklyn, New York | |
| Maine Children's Cancer Program Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Mary Bridge Children's Hospital and Health Center Tacoma, Washington | Site Public Contact - (research@multicare.org) |
| Massachusetts General Hospital Cancer Center Boston, Massachusetts | |
| Mattel Children's Hospital UCLA Los Angeles, California | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| McMaster Children's Hospital at Hamilton Health Sciences Hamilton, Ontario | |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| Medical City Dallas Hospital Dallas, Texas | |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Memorial Health University Medical Center Savannah, Georgia | Site Public Contact - (Lorraine.OHara@hcahealthcare.com) |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (OHR@mhs.net) |
| 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 | |
| Miller Children's and Women's Hospital Long Beach Long Beach, California | |
| 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) |
| Morristown Medical Center Morristown, New Jersey | |
| Mount Sinai Hospital New York, New York | |
| 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) |
| Naval Medical Center - Portsmouth Portsmouth, Virginia | |
| Nemours Children's Clinic - Pensacola Pensacola, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.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) |
| 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) |
| Palms West Radiation Therapy Loxahatchee Groves, Florida | |
| Penn State Children's Hospital Hershey, Pennsylvania | |
| Perth Children's Hospital Perth, Western Australia | |
| Phoenix Childrens Hospital Phoenix, Arizona | |
| 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 | |
| Renown Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Rhode Island Hospital Providence, Rhode Island | |
| 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) |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey | |
| Sacred Heart Hospital Pensacola, Florida | |
| 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 | |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Mary's Medical Center West Palm Beach, Florida | |
| Saint Peter's University Hospital New Brunswick, New Jersey | Site Public Contact - (kcovert@saintpetersuh.com) |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.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) |
| Santa Barbara Cottage Hospital Santa Barbara, California | |
| Scott and White Memorial Hospital Temple, Texas | |
| 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 | |
| Summerlin Hospital Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Sunrise Hospital and Medical Center Las Vegas, Nevada | |
| Sydney Children's Hospital Randwick, New South Wales | |
| T C Thompson Children's Hospital Chattanooga, Tennessee | |
| Tampa General Hospital Tampa, Florida | Site Public Contact - (syapchanyk@tgh.org) |
| 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 | Site Public Contact - (info@thechildren.com) |
| The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York | |
| Tufts Children's Hospital Boston, Massachusetts | |
| UCSF Benioff Children's Hospital Oakland Oakland, California | Site Public Contact - (PedOncRschOAK@ucsf.edu) |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UF Health Cancer Institute - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| UMass Memorial Medical Center - University Campus Worcester, Massachusetts | Site Public Contact - (cancer.research@umassmed.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 Medical Center of Southern Nevada Las Vegas, Nevada | |
| University Pediatric Hospital San Juan, | |
| University of Alberta Hospital Edmonton, Alberta | Site Public Contact - (pedsoncologyresearch@ahs.ca) |
| 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 Illinois Chicago, Illinois | |
| 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 Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Missouri Children's Hospital Columbia, Missouri | |
| 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 Rochester Rochester, New York | |
| University of Texas Health Science Center at San Antonio San Antonio, Texas | Site Public Contact - (phoresearchoffice@uthscsa.edu) |
| University of Vermont and State Agricultural College Burlington, Vermont | Site Public Contact - (rpo@uvm.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 | |
| Walter Reed National Military Medical Center Bethesda, Maryland | |
| 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) |
Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial)
ctrrecruit@vcu.edu
NCT06317649
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Inclusion Criteria:
* Patient must be ≥ 60 years of age or adults ˂ 60 who in the opinion of the treating physician are better served by azanucleoside-based therapy rather than intensive, cytarabine-based induction based on clinical status (i.e., performance status, age \> 75 years), organ dysfunction, or disease biology
* Patient must have a morphologically confirmed diagnosis of AML according to the World Health Organization (WHO) 2016 classification excluding acute promyelocytic leukemia (APL) with PML-RARA, AML with RUNX1-RUNX1T1, or AML with CBFB-MYH11
* Patient must have no prior therapy for AML with the exception of hydroxyurea and all-trans retinoic acid (ATRA), or leukapheresis. Patients with cytarabine-based emergency therapy prior to the start of therapy on this trial are eligible
* Patient must have no prior therapy with hypomethylating agents or FLT3 inhibitors
* Patient must have the FLT3-ITD or D835 mutation based on MyeloMATCH Master Screening and Reassessment Protocol (MSRP)
* Patient must be assigned to this protocol by the myeloMATCH MSRP
* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.
* All patients of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy.
* A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
* Patient of childbearing potential and/or sexually active patients must not expect to conceive or father children by using an accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study. Contraception measures must continue for 30 days after the last dose of venetoclax for all patients and for 6 months after the last dose of gilteritinib for patients of childbearing potential and for 4 months after the last dose of gilteritinib for male patients with partners of childbearing potential. Patient must not breastfeed during treatment and for 2 months after treatment ends
* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
* Total bilirubin 2X ≤ institutional upper limit of normal (ULN) (unless thought to be elevated due to disease involvement or Gilbert's syndrome)
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3.0 x institutional ULN
* Either measured or estimated by Cockcroft-Gault equation
* Creatinine clearance of ≥ 30 mL/min/1.73m\^2
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration/randomization are eligible for this trial
* Patients must not have a baseline corrected QT interval ≥ 480 msec using Fredericia correction (QTcF).
NOTE: Since older patients are at risk for prolonged QTc and many will require supportive care with agents that affect the QTc, an ECG is recommended if clinically indicated. If the QTc is prolonged, they should be treated on tier advancement process (TAP) instead of EA02
* 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
* Patient must not have the medical necessity for ongoing treatment with a strong CYP3A4 inducing drug
* 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
* Patients must not have an active or uncontrolled infection DRUG: Azacitidine, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, DRUG: Gilteritinib, DRUG: Venetoclax
Acute Myeloid Leukemia
I'm interested
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Show 211 locations
Study Locations
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| Location | Contacts |
|---|---|
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Allegiance Health Jackson, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Alta Bates Summit Medical Center-Herrick Campus Berkeley, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
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Oral Azacitidine in Transplant-Eligible Patients With Acute Myeloid Leukemia (AML) Suffering From Health-Inequality (REMAIN1)
Massey IIT Research Operations - masseyepd@vcu.edu
NCT06370000
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Inclusion Criteria:
* Patients must have histologically or cytologically confirmed non-Acute Promyelocytic (APL) FLT3 negative AML and have completed induction and consolidation as defined by the treating physician and must be in complete response (CR), Complete response with partial hematologic recovery (CRh), or Complete response with incomplete count recovery (CRi) at time of study enrollment
* For patients in CR1, AML disease phenotype must be one that is considered for allo HCT in CR1 (intermediate or high risk by European Leukemia Net (ELN), MRD+ CR, slow clearance of MRD) or any AML phenotype (aside from FLT3+ and APL) in CR2 and beyond
* Medically eligible for allogeneic hematopoietic cell transplant (allo HCT) as defined by either: treating physician discretion, transplant physician discretion, or hematopoietic cell transplantation-specific Comorbidity index (HCT-CI) index of 5 or less
* Age ≥ 18 years
* Enrollment must occur within 4 months of completion of therapy
* A patient or staff identified health disparity in 1 of the 5 Centers for Disease Control (CDC) defined social determinants of health (SDOH). This may include financial difficulties, lack of caregiver support, difficulties with medical literacy, rurality, appropriate access to health care, lack of an appropriate allogeneic hematopoietic cell transplant (allo HCT) donor, substance abuse
* Patient must have adequate organ function defined as: Creatinine clearance (by Cockroft-Gault formula) greater than or equal to 29 mL/min, total bilirubin and aspartate aminotransferase/ alanine transaminase (AST/ALT) ≤ to institutional 2x upper limit of normal (except Gilbert's syndrome, which may enroll if \< 2x patient's baseline total bilirubin)
* Eastern Cooperative Oncology Group (ECOG) 0,1,2,3
* Ability to take oral medications
* No history of malabsorption syndrome which, in the investigator's opinion, may inhibit absorption of oral medications
* Women of childbearing potential must consent to effective contraception during study treatment and at least 6 months following the last dose. Women who are breastfeeding are also excluded
* Male patients must consent to effective contraception during study and at least 3 months after last dose
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria A patient who meets any of the following exclusion criteria is ineligible to participate in the study.
* FMS-like tyrosine kinase 3 (FLT3 ITD) or tyrosine kinase domain (TKD) mutation
* Uncontrolled central nervous system (CNS) involvement
* History of hypersensitivity or allergic reaction to azacitidine or its components
* Stem cell transplant within previous 3 months prior to initiation of study therapy
* Uncontrolled intercurrent illness or infection
* History of prior therapy with oral azacitidine
* Female patients who are pregnant or intend to donate eggs during the study or for 6 months after receiving their last dose of study drug
* Male patients who intend to donate sperm during the course of this study or for 3 months after last dose
* Other malignancy for which the patient is currently receiving therapy (except excisable skin cancer)
* Medical, psychological, or social condition that, in the opinion of the investigator, may increase the participant's risk or limit the participant's adherence with study requirements DRUG: Oral Azacitidine
Acute Myeloid Leukemia
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Massey CTO Heme Team - (MasseyHemMlg@vcu.edu) |
Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)
Gwen Nichols, MD - gwen.nichols@lls.org
NCT05183035
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Inclusion Criteria
* Participants must have enrolled on APAL2020SC, NCT Number: NCT04726241 prior to enrollment on ITCC-101/APAL2020D. (This is only applicable for participants in USA/Canada/Australia/New Zealand sites/Blood Cancer United territory).
* Participants must be ≥ 29 days of age and ≤ 21 years of age at enrollment.
* Participants must have one of the following:
• Children, adolescents, and young adults with AML without demonstrated FLT3/internal tandem duplication (ITD) mutation. Ideally, the status of the mutation needs to be proven in the current relapse. Nevertheless, patients with previous FLT3/ITD negative test from prior lines can be included based on local results in order to not delay the start of treatment.
• And participants must have AML which is either: * Untreated second relapse, in participants who are sufficiently fit to undergo another round of intensive chemotherapy, or * Untreated first relapse, in participants who cannot tolerate additional anthracycline containing chemotherapy per investigator discretion. * Participants must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2 (≥ 50% Lansky or Karnofsky score). * Participants must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to start of protocol treatment:
• Cytotoxic chemotherapy: Must not have received cytotoxic chemotherapy within 14 days prior to start of protocol treatment, except for corticosteroids, low dose cytarabine or hydroxyurea that can be given up to 24 hours prior to start of protocol treatment.
• Intrathecal cytotoxic therapy: No wash-out time is required for participants having received any combination of intrathecal cytarabine, methotrexate, and/or hydrocortisone.
• Antibodies: ≥ 21 days must have elapsed from infusion of last dose of an antibody-drug conjugate before start of protocol treatment. For unmodified antibodies or T cell engaging antibodies, 2 half-lives must have elapsed before start of protocol treatment. Any toxicity related to prior antibody therapy must be recovered to Grade ≤ 1.
• Interleukins, Interferons and Cytokines (other than Hematopoietic Growth Factors): ≥ 21 days after the completion of interleukins, interferon or cytokines (other than Hematopoietic Growth Factors) before start of protocol treatment.
• Hematopoietic growth factors: ≥ 14 days after the last dose of a long-acting growth factor (e.g., pegfilgrastim) or ≥7 days for short-acting growth factor before start of protocol treatment.
• Radiation therapy (RT) (before start of protocol treatment): * ≥ 14 days have elapsed for local palliative RT (small port); * ≥ 84 days must have elapsed if prior craniospinal RT or if ≥ 50% radiation of pelvis; * ≥ 42 days must have elapsed if other substantial bone marrow (BM) radiation.
• Stem Cell Infusions (before start of protocol treatment): * ≥ 84 days since allogeneic (non-autologous) bone marrow or stem cell transplant (with or without total body irradiation \[TBI\]) or boost infusion (any stem cell product; not including donor lymphocyte infusion \[DLI\]); * No evidence of active graft versus host disease (GVHD).
• Participants who are receiving cyclosporine, tacrolimus or other agents to treat or prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant are not eligible for this trial. Participants must be off medications to treat or prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant for at least 14 days prior to enrollment.
• Cellular Therapy: ≥ 42 days after the completion of donor lymphocyte infusion (DLI) or any type of cellular therapy (e.g., modified T cells, natural killer \[NK\] cells, dendritic cells, etc.) before start of protocol treatment.
• Participants with prior exposure to venetoclax are eligible in this trial. * Adequate organ function:
• Adequate Renal Function defined as: * Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 60ml/min/1.73 m\^2, or * Normal serum creatinine based on age/sex
• Adequate Liver Function defined as: * Direct bilirubin \< 1.5 x upper limit of normal (ULN), and * Alkaline phosphatase ≤ 2.5 x ULN, and * Serum glutamic pyruvic transaminase (SGPT) alanine aminotransferase (ALT) ≤ 2.5 x ULN. If higher transaminases outside these ranges (up to 5x ULN) are due to a radiographically identifiable leukemia infiltrate, the participant will remain eligible. Transaminase elevation up to 5x ULN is also allowed in case of steatosis on echography.
• Cardiac performance: Minimum cardiac function defined as: * No history of congestive heart failure in need of medical treatment * No pre-treatment diminished left ventricular function on echocardiography (shortening fraction \[SF\] \< 25% or ejection fraction \[EF\] \< 40%) * No signs of congestive heart failure at presentation of relapse. * Participant, parent or guardian must sign and date informed consent and pediatric assent (when required), prior to the initiation of screening or study specific procedures, according to local law and legislation. Exclusion Criteria * Participants who in the opinion of the investigator may not be able to comply with the study requirements of the study, are not eligible. * Participants with Down syndrome. * Participants with Acute promyelocytic leukemia (APL) or Juvenile myelomonocytic leukemia (JMML). * Participants with isolated CNS3 disease or symptomatic CNS3 disease. * Participants with malabsorption syndrome or any other condition that precludes enteral administration of venetoclax. * Participants who are currently receiving an investigational drug other than those specified for this study. * Participants with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known congenital bone marrow failure syndrome. * Participants with known prior allergy to any of the medications used in protocol therapy. * Participants with documented active, uncontrolled infection at the time of study entry. * Known hepatitis C virus (HCV), hepatitis B virus (HBV) (known positive hepatitis B virus (HBV) surface antigen (HBsAg) results), or human immunodeficiency virus (HIV) infection. * Concomitant Medications * Participants who have received strong and moderate CYP3A inducers such as rifampin, carbamazepine, phenytoin, and St. John's wort within 7 days of the start of study treatment. * Participants who have consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or starfruit within 3 days of the start of study treatment. * Participants who have hypersensitivity to the active substance or to any of the excipients listed in summary of product characteristics (SPC). * Pregnancy or Breast-Feeding: * Participants who are pregnant or breast-feeding. * Participants of reproductive potential may not participate unless they have agreed to use a highly effective contraceptive method per Clinical Trial Facilitation Group (CTFG) guidelines for the duration of study therapy and at least 30 days after last dose of venetoclax, or 7 months after gemtuzumab ozogamicin treatment, or for 6 months after the completion of all study therapy, whichever is longer. * Male participants must use a condom during intercourse and agree not to father a child or donate sperm during therapy and for the duration of study therapy and at least 30 days after last dose of venetoclax or 4 months after last dose of gemtuzumab ozogamicin, 6 months from the last dose of cytarabine, or 90-days after last exposure to any other chemotherapy, whichever is longer. Additional criteria to receive a gemtuzumab ozogamicin infusion: Gemtuzumab ozogamicin should not be given: * to participants with history of veno-occlusive disease (VOD)/Sinusoidal obstruction syndrome (SOS) grade 3 or 4 * to participants with CD33 negative leukemic blasts (determined at local lab) Note that these participants are eligible for the study but will not be treated with gemtuzumab ozogamicin.
• Children, adolescents, and young adults with AML without demonstrated FLT3/internal tandem duplication (ITD) mutation. Ideally, the status of the mutation needs to be proven in the current relapse. Nevertheless, patients with previous FLT3/ITD negative test from prior lines can be included based on local results in order to not delay the start of treatment.
• And participants must have AML which is either: * Untreated second relapse, in participants who are sufficiently fit to undergo another round of intensive chemotherapy, or * Untreated first relapse, in participants who cannot tolerate additional anthracycline containing chemotherapy per investigator discretion. * Participants must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2 (≥ 50% Lansky or Karnofsky score). * Participants must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to start of protocol treatment:
• Cytotoxic chemotherapy: Must not have received cytotoxic chemotherapy within 14 days prior to start of protocol treatment, except for corticosteroids, low dose cytarabine or hydroxyurea that can be given up to 24 hours prior to start of protocol treatment.
• Intrathecal cytotoxic therapy: No wash-out time is required for participants having received any combination of intrathecal cytarabine, methotrexate, and/or hydrocortisone.
• Antibodies: ≥ 21 days must have elapsed from infusion of last dose of an antibody-drug conjugate before start of protocol treatment. For unmodified antibodies or T cell engaging antibodies, 2 half-lives must have elapsed before start of protocol treatment. Any toxicity related to prior antibody therapy must be recovered to Grade ≤ 1.
• Interleukins, Interferons and Cytokines (other than Hematopoietic Growth Factors): ≥ 21 days after the completion of interleukins, interferon or cytokines (other than Hematopoietic Growth Factors) before start of protocol treatment.
• Hematopoietic growth factors: ≥ 14 days after the last dose of a long-acting growth factor (e.g., pegfilgrastim) or ≥7 days for short-acting growth factor before start of protocol treatment.
• Radiation therapy (RT) (before start of protocol treatment): * ≥ 14 days have elapsed for local palliative RT (small port); * ≥ 84 days must have elapsed if prior craniospinal RT or if ≥ 50% radiation of pelvis; * ≥ 42 days must have elapsed if other substantial bone marrow (BM) radiation.
• Stem Cell Infusions (before start of protocol treatment): * ≥ 84 days since allogeneic (non-autologous) bone marrow or stem cell transplant (with or without total body irradiation \[TBI\]) or boost infusion (any stem cell product; not including donor lymphocyte infusion \[DLI\]); * No evidence of active graft versus host disease (GVHD).
• Participants who are receiving cyclosporine, tacrolimus or other agents to treat or prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant are not eligible for this trial. Participants must be off medications to treat or prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant for at least 14 days prior to enrollment.
• Cellular Therapy: ≥ 42 days after the completion of donor lymphocyte infusion (DLI) or any type of cellular therapy (e.g., modified T cells, natural killer \[NK\] cells, dendritic cells, etc.) before start of protocol treatment.
• Participants with prior exposure to venetoclax are eligible in this trial. * Adequate organ function:
• Adequate Renal Function defined as: * Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 60ml/min/1.73 m\^2, or * Normal serum creatinine based on age/sex
• Adequate Liver Function defined as: * Direct bilirubin \< 1.5 x upper limit of normal (ULN), and * Alkaline phosphatase ≤ 2.5 x ULN, and * Serum glutamic pyruvic transaminase (SGPT) alanine aminotransferase (ALT) ≤ 2.5 x ULN. If higher transaminases outside these ranges (up to 5x ULN) are due to a radiographically identifiable leukemia infiltrate, the participant will remain eligible. Transaminase elevation up to 5x ULN is also allowed in case of steatosis on echography.
• Cardiac performance: Minimum cardiac function defined as: * No history of congestive heart failure in need of medical treatment * No pre-treatment diminished left ventricular function on echocardiography (shortening fraction \[SF\] \< 25% or ejection fraction \[EF\] \< 40%) * No signs of congestive heart failure at presentation of relapse. * Participant, parent or guardian must sign and date informed consent and pediatric assent (when required), prior to the initiation of screening or study specific procedures, according to local law and legislation. Exclusion Criteria * Participants who in the opinion of the investigator may not be able to comply with the study requirements of the study, are not eligible. * Participants with Down syndrome. * Participants with Acute promyelocytic leukemia (APL) or Juvenile myelomonocytic leukemia (JMML). * Participants with isolated CNS3 disease or symptomatic CNS3 disease. * Participants with malabsorption syndrome or any other condition that precludes enteral administration of venetoclax. * Participants who are currently receiving an investigational drug other than those specified for this study. * Participants with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known congenital bone marrow failure syndrome. * Participants with known prior allergy to any of the medications used in protocol therapy. * Participants with documented active, uncontrolled infection at the time of study entry. * Known hepatitis C virus (HCV), hepatitis B virus (HBV) (known positive hepatitis B virus (HBV) surface antigen (HBsAg) results), or human immunodeficiency virus (HIV) infection. * Concomitant Medications * Participants who have received strong and moderate CYP3A inducers such as rifampin, carbamazepine, phenytoin, and St. John's wort within 7 days of the start of study treatment. * Participants who have consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or starfruit within 3 days of the start of study treatment. * Participants who have hypersensitivity to the active substance or to any of the excipients listed in summary of product characteristics (SPC). * Pregnancy or Breast-Feeding: * Participants who are pregnant or breast-feeding. * Participants of reproductive potential may not participate unless they have agreed to use a highly effective contraceptive method per Clinical Trial Facilitation Group (CTFG) guidelines for the duration of study therapy and at least 30 days after last dose of venetoclax, or 7 months after gemtuzumab ozogamicin treatment, or for 6 months after the completion of all study therapy, whichever is longer. * Male participants must use a condom during intercourse and agree not to father a child or donate sperm during therapy and for the duration of study therapy and at least 30 days after last dose of venetoclax or 4 months after last dose of gemtuzumab ozogamicin, 6 months from the last dose of cytarabine, or 90-days after last exposure to any other chemotherapy, whichever is longer. Additional criteria to receive a gemtuzumab ozogamicin infusion: Gemtuzumab ozogamicin should not be given: * to participants with history of veno-occlusive disease (VOD)/Sinusoidal obstruction syndrome (SOS) grade 3 or 4 * to participants with CD33 negative leukemic blasts (determined at local lab) Note that these participants are eligible for the study but will not be treated with gemtuzumab ozogamicin.
DRUG: Fludarabine, DRUG: Cytarabine, DRUG: Gemtuzumab Ozogamicin, DRUG: Azacitidine, DRUG: Venetoclax
Acute Myeloid Leukemia
Venetoclax, Gemtuzumab Ozogamicin, Fludarabine, Cytarabine, Relapsed refractory, Azacitidine
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Study Locations
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| Location | Contacts |
|---|---|
| Alberta Children's Hospital Calgary, Alberta | |
| Alliance for Childhood Diseases dba Cure 4 The Kids Foundation Las Vegas, Nevada | |
| Ann & Robert H. Lurie Children's Hospital of Chicago Chicago, Illinois | |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Benioff Children's Hospital - Mission Bay San Francisco, California | |
| British Columbia Children's Hospital Vancouver, British Columbia | |
| C.S. Mott Children's Hospital Ann Arbor, Michigan | |
| CHU de Nantes - Hôpital Femme-Enfant-Adolescent Nantes, Loire-Atlantique | |
| CHU de Toulouse - Hopital des Enfants Toulouse, Haute-Garonne | |
| CancerCare Manitoba Winnipeg, Manitoba | |
| Charite - Universitatsmedizin Berlin Berlin, | |
| Children's Health Queensland Hospital and Health Service South Brisbane, Queensland | |
| Children's Healthcare of Atlanta Atlanta, Georgia | |
| Children's Hospital Colorado Aurora, Colorado | |
| Children's Hospital Of Eastern Ontario Ottawa, Ontario | |
| Children's Hospital of Michigan Detroit, Michigan | |
| Children's Hospital of Orange County Main Campus - Orange Orange, California | |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | |
| Children's Hospital of Richmond at Virginia Commonwealth University Richmond, Virginia | |
| Cohen Children's Medical Center Queens, New York | |
| Columbia University Irving Medical Center New York, New York | |
| Comer Children's Hospital Chicago, Illinois | |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Doernbecher Children's Hospital Portland, Oregon | |
| Fakultni nemocnice v Motole Prague, Prague | |
| Fondazione IRCCS San Gerardo dei Tintori Monza, Monza and Brianza | |
| Golisano Children's Hospital of Southwest Florida Fort Myers, Florida | |
| Hackensack University Medical Center, HMH Hackensack, New Jersey | |
| Harold C. Simmons Comprehensive Cancer Center Dallas, Texas | |
| Hopital Jeanne de Flandre Loos, Hauts-de-France | |
| Hospital Infantil Universitario Nino Jesus Madrid, | |
| Hospital Sant Joan de Déu Barcelona Barcelona, | |
| Hospital Universitari Vall d'Hebron Barcelona, Barcelona [barcelona] | |
| Hospital Universitario La Fe Valencia, | |
| Hyogo Prefectural Kobe Children's Hospital Kobe, Hyōgo | |
| Hôpital Armand-Trousseau Paris, Île-de-France Region | |
| Hôpital Universitaire Robert-Debré Paris, Île-de-France Region | |
| Indiana University School of Medicine Indianapolis, Indiana | |
| Institut d'Hématologie et d'Oncologie Pédiatrique Lyon, Rhône | |
| Instituto Portugues De Oncologia De Lisboa Francisco Gentil Lisbon, Lisbon District | |
| Istituto Giannina Gaslini Genova, Genoa | |
| Izaak Walton Killam (IWK) Health Center Halifax, Nova Scotia | |
| Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital Nagoya, Aiti | |
| Kapi'olani Medical Center for Women and Children Honolulu, Hawaii | |
| Karolinska Universitetssjukhuset Solna Stockholm, Stockholm County | |
| Masonic Cancer Center Minneapolis, Minnesota | |
| Memorial Sloan Kettering Cancer Center - New York New York, New York | |
| MemorialCare Miller Children's and Women's Hospital Long Beach Long Beach, California | |
| Monroe Carell Jr. Children's Hospital at Vanderbilt Nashville, Tennessee | |
| Morristown Medical Center Morristown, New Jersey | |
| National Center for Child Health and Development Setagaya-Ku, Tokyo | |
| Nationwide Children's Hospital Columbus, Ohio | |
| Nemours Alfred I. duPont Hospital for Children Wilmington, Delaware | |
| Nemours Children's Hospital - Orlando Orlando, Florida | |
| Nemours Children's Specialty Care Jacksonville Jacksonville, Florida | |
| Norton Children's Hospital Louisville, Kentucky | |
| Osaka City General Hospital Osaka, | |
| Oslo Universitetssykehus Oslo, | |
| Ospedale Infantile Regina Margherita Torino, Turin | |
| Ospedale Pediatrico Bambino Gesu Roma, Rome | |
| Padiatrische Hamatologie und Onkologie Münster, | |
| Perth Children's Hospital Perth, Western Australia | |
| Phoenix Children's Hospital Phoenix, Arizona | |
| Primary Children's Hospital Salt Lake City, Utah | |
| Prinses Maxima Centrum Kinderoncologie Utrecht, | |
| Prisma Health Richland Hospital Columbia, South Carolina | |
| Rigshospitalet Copenhagen, Capital Region | |
| Saint Joseph's Hospital - Tampa Tampa, Florida | |
| Saitama Prefectural Children's Medical Center Saitama-Shi, Saitama | |
| Sankt Anna-Kinderspital Vienna, | |
| Schneider Children's Medical Center of Israel Petach Tikvah, Central District | |
| Seattle Children's Hospital Seattle, Washington | |
| SickKids - The Hospital for Sick Children Toronto, Ontario | |
| St. Jude Children's Research Hospital Memphis, Tennessee | |
| Starship Children's Hospital Grafton, Auckland | |
| Texas Children's Hospital Houston, Texas | |
| The Children's Mercy Hospital - Adele Hall Campus Kansas City, Missouri | |
| The Royal Children's Hospital - Children's Cancer Centre Parkville, Victoria | |
| Universitaets - Kinderspital Zürich Zurich, | |
| Universitair Ziekenhuis Gent Ghent, Oost-Vlaanderen | |
| University of Florida Health Shands Children's Hospital Gainesville, Florida | |
| University of Iowa Stead Family Children's Hospital Iowa City, Iowa | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| Universitätsklinikum Augsburg Augsburg, | |
| Universitätsklinikum Frankfurt Frankfurt, | |
| Universitätsklinikum Münster Münster, North Rhine-Westphalia | |
| Uusi Lastensairaala Helsinki, Etelä-Suomen Lääni | |
| Washington University School of Medicine in St. Louis St Louis, Missouri | |
| Yale University New Haven, Connecticut |
A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) (cAMeLot-2)
Study Contact - Participate-In-This-Study1@its.jnj.com
NCT06852222
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Inclusion criteria:
* Be 18 years of age or older at the time of informed consent
* Previously untreated lysine N-methyltransferase 2A gene rearranged (KMT2Ar) or nucleophosmin 1 gene mutated (NPM1m) acute myeloid leukemia (AML) with greater than or equal to (\> or =) 10% bone marrow blasts per 2022 international Consensus Classification criteria
* Ineligible for intensive chemotherapy based on the following criteria: a) \>= 75 years of age and ineligible per physician's discretion, with Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, b) \>=18 to \<75 years of age with \>= 1 of the following comorbidities: i) ECOG performance status of 2, ii) Severe cardiac disorder, iii) Severe pulmonary disorder, iv) Renal impairment, v) Moderate hepatic impairment vi) Comorbidity that, in the investigator's opinion, makes the participant unsuitable for intensive chemotherapy, which must be documented before enrollment as defined in the protocol. Ineligibility for intensive chemotherapy should be explicitly approved by a multidisciplinary team in countries in which this process is standard of care
* Participants must have adequate hepatic and renal function
* A female participant must agree not to be pregnant, breast-feed, plan to become pregnant and use protocol-specified contraception while enrolled in this study and for 6 months after the last dose of study treatment
* A male participant must agree to use protocol-specified contraception while enrolled in this study for at least 90 days after the last dose of study treatment
* Must sign an informed consent form indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
Exclusion criteria:
* Diagnosis of acute promyelocytic leukemia (APL)
* Known active leukemic involvement of the central nervous system (CNS)
* Recipient of solid organ transplant
* Any cardiac disorders such as heart attack, uncontrolled/unstable chest pain, congestive heart failure, uncontrolled or symptomatic irregular heartbeat, blockage of a blood vessel to brain, or transient ischemic (decreased oxygen in tissue) attack within 6 months of randomization
* Active infectious hepatitis
* Live, attenuated vaccine within 4 weeks of randomization
* Known allergies, hypersensitivity, or intolerance of bleximenib, azacitidine, or venetoclax excipients
DRUG: Bleximenib, DRUG: Venetoclax (VEN), DRUG: Azacitidine (AZA), DRUG: Placebo
Leukemia, Myeloid, Acute
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Show 227 locations
Study Locations
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| Location | Contacts |
|---|---|
| A O U Sant Orsola Malpighi Bologna, | |
| AHEPA University General Hospital of Thessaloniki Thessaloniki, | |
| ASST Grande Ospedale Metropolitano Niguarda Milan, | |
| ASST Papa Giovanni XXIII Bergamo Bergamo, | |
| AST Pesaro e Urbino Ospedale San Salvatore Pesaro, | |
| AZ Sint-Jan Bruges, | |
| Aalborg University Hospital Aalborg, | |
| Addenbrookes Hospital Cambridge, | |
| Aiiku Hospital Sapporo, | |
| Algemeen Ziekenhuis Delta Roeselare, | |
| Ankara Etlik Sehir Hastanesi Ankara, | |
| Ankara University School of Medicine Cebeci Hospital Ankara, | |
| Arthur J E Child Comprehensive Cancer Centre Calgary, Alberta | |
| Asan Medical Center Seoul, | |
| Atrium Health Charlotte, North Carolina | |
| Atrium Health Wake Forest Baptist Comprehensive Cancer Center Winston-Salem, North Carolina | |
| Azienda Ospedaliera Spedali Civili di Brescia Brescia, | |
| Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia Perugia, | |
| Baylor University Medical Center Dallas, Texas | |
| CHRU de Nancy - Hôpitaux de Brabois Vandœuvre-lès-Nancy, | |
| CHU De Nice Hopital De l'Archet Nice, | |
| CHU Lyon Sud Pierre-Bénite, | |
| CHU Reims Hopital Robert Debre Reims, | |
| CHU d'Angers Angers, | |
| CHU de Clermont Ferrand - Site Estaing Clermont-Ferrand, | |
| CHU de Montpellier Hopital Saint Eloi Montpellier, | |
| CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont Montreal, Quebec | |
| Cancer Treatment Center of America Phoenix Goodyear, Arizona | |
| CancerCare Manitoba Winnipeg, Manitoba | |
| Carmel Medical Center Haifa, | |
| Casa Sollievo della Sofferenza IRCCS San Giovanni Rotondo, | |
| Centro de Investigacion Clinica Chapultepec Mexico City, | |
| Chaim Sheba Medical Center Ramat Gan, | |
| Chi Mei Medical Center Liouying Branch Tainan, | |
| Chu Helora Hospital La Louviere Site Jolimont La Louvière, | |
| Chu Rennes Hopital Pontchaillou Rennes, | |
| Chungnam National University Hospital Daejeon, | |
| City of Hope Duarte, California | |
| Cleveland Clinic Cleveland, Ohio | |
| Cleveland Clinic Florida Weston, Florida | |
| Clinica Univ. de Navarra Pamplona, | |
| Clinica Univ. de Navarra Pamplona, | |
| Clinique Saint Pierre Ottignies, | |
| Colchester Hospital University NHS Colchester, | |
| Dana Farber Cancer Institute Boston, Massachusetts | |
| Dartmouth Hitchcock Medical Center Lebanon, New Hampshire | |
| Derriford Hospital Plymouth, | |
| Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital Ankara, | |
| Einstein-Montefiore Medical Center The Bronx, New York | |
| Evaggelismos Hospital Athens, | |
| Fakultni Nemocnice Ostrava Ostrava - Poruba, | |
| Fakultni nemocnice Hradec Kralove Hradec Králové, | |
| Fakultni nemocnice Kralovske Vinohrady Prague, | |
| Fakultni nemocnice Plzen Pilsen, | |
| Fakultní nemocnice Brno, Interní hematologická a onkologická klinika Brno, | |
| First Affiliated Hospital SooChow University Suzhou, | |
| Flinders Medical Centre Bedford Park, | |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan, | |
| Fondazione IRCCS Policlinico San Matteo Pavia, | |
| Fox Chase Cancer Center Philadelphia, Pennsylvania | |
| Fred Hutchinson Cancer Center Seattle, Washington | |
| Fukushima Medical University Hospital Fukushima, | |
| Fundacao Pio XII Barretos, | |
| Gabrail Cancer Center Canton, Ohio | |
| General Hospital of Athens Attikon Chaïdári, | |
| General University Hospital of Patras Rio, | |
| Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki, | |
| Ghent University Hospital Ghent, | |
| Gifu Municipal Hospital Gifu, | |
| Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria Reggio Calabria, | |
| Gunmaken Saiseikai Maebashi Hospital Maebashi, | |
| Guys' and St Thomas' NHS Trust London, | |
| Hadassah University Hospita Ein Kerem Jerusalem, | |
| Henan Cancer Hospital Zhengzhou, | |
| Henry Ford Health System Detroit, Michigan | |
| Hopital Saint Louis Paris, | |
| Hopital Saint Vincent de Paul Lille, | |
| Hosp Clinico Univ de Salamanca Salamanca, | |
| Hosp Univ A Coruna A Coruña, | |
| Hosp Univ Vall D Hebron Barcelona, | |
| Hosp. Clinic de Barcelona Barcelona, | |
| Hosp. Quiron Madrid Pozuelo Pozuelo de Alarcón, | |
| Hosp. San Pedro de Alcantara Cáceres, | |
| Hosp. Univ. 12 de Octubre Madrid, | |
| Hosp. Univ. I Politecni La Fe Valencia, | |
| Hosp. Univ. Marques de Valdecilla Santander, | |
| Hosp. Univ. Ramon Y Cajal Madrid, | |
| Hosp. Virgen Del Rocio Seville, | |
| Hosp. de Jerez de La Frontera Jerez de la Frontera, | |
| Hosp. de La Santa Creu I Sant Pau Barcelona, | |
| IRCCS Istituto Clinico Humanitas Rozzano, | |
| Inst. Cat. Doncologia-H Duran I Reynals L'Hospitalet de Llobregat, | |
| Institut Paoli Calmettes Marseille, | |
| Institut Universitaire du Cancer Toulouse Oncopole Toulouse, | |
| Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences Tijian, | |
| Instituto D Or de Pesquisa e Ensino Salvador, | |
| Instituto D Or de Pesquisa e Ensino Salvador, | |
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Barrio Belisario Domínguez Secc XVI, Mexico CITY (federal District) | |
| Instituto Portugues de Oncologia Porto, | |
| Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI) Rio de Janeiro, | |
| Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori Meldola, | |
| Japanese Red Cross Osaka Hospital Osaka, | |
| Juravinski Cancer Centre Hamilton, Ontario | |
| Kanazawa University Hospital Kanazawa, | |
| Kaohsiung Chang Gung Memorial Hospital Kaohsiung City, | |
| Kent and Canterbury Hospital Canterbury, | |
| Kepler Universitatsklinikum GmbH Linz, | |
| Klinikum Augsburg Augsburg, | |
| Kobe City Medical Center General Hospital Kobe, | |
| Koc University Medical Faculty Istanbul, | |
| Kyushu University Hospital Fukuoka, | |
| Liga Norte Riograndense Contra O Cancer Natal, | |
| Liga Paranaense de Combate ao Cancer Curitiba, | |
| Linkou Chang Gung Memorial Hospital Taoyuan District, | |
| London Health Sciences Centre Victoria Hospital London, Ontario | |
| MD Anderson Cancer Center Houston, Texas | |
| Mary Bird Perkins Cancer Center Baton Rouge, Louisiana | |
| Memorial Antalya Hospital Antalya, | |
| Ministerio da Saude Instituto Nacional do Cancer Rio de Janeiro, | |
| Moffit Cancer Center Tampa, Florida | |
| Nagoya University Hospital Nagoya, | |
| National Cancer Center Gyeonggi-do, | |
| National Hospital Organization Kumamoto Medical Center Kumamoto, | |
| National Taiwan University Hospital Taipei, | |
| New York Presbyterian - Weill Cornell New York, New York | |
| Nippon Medical School Hospital Tokyo, | |
| Norton Cancer Institute Louisville, Kentucky | |
| Novant Health Winston-Salem, North Carolina | |
| Novant Health Winston-Salem, North Carolina | |
| Odense University Hospital Odense, | |
| Okayama University Hospital Okayama-Shi Kita-Ku, | |
| Ondokuz Mayis University Samsun, | |
| Ordensklinikum Linz GmbH Elisabethinen Linz, | |
| Orlando Health Cancer Institute Orlando, Florida | |
| Ospedale S. Maria Delle Croci Ravenna, | |
| Peking University First Hospital Beijing, | |
| Peking University People's Hospital Beijing, | |
| Peking University Third Hospital Beijing, | |
| Peter MacCallum Cancer Centre Melbourne, Victoria | |
| Princess Alexandra Hospital Woolloongabba, | |
| Princess Margaret Cancer Centre University Health Network Toronto, Ontario | |
| Providence Oncology and Hematology Care Clinic Westside Portland, Oregon | |
| Providence Portland Medical Center Portland, Oregon | |
| Qilu Hospital of Shandong University Jinan, | |
| Queen Elizabeth II Health Sciences Centre Halifax, Nova Scotia | |
| Queen Mary Hospital Hong Kong, | |
| Rabin Medical Center Petah Tikva, | |
| Rambam Medical Center Haifa, | |
| Real e Benemérita Associação Portuguesa de Beneficência São Paulo, | |
| Roswell Park Comprehensive Cancer Center Buffalo, New York | |
| Royal Prince Alfred Hospital Camperdown, | |
| Sakarya University Training and Research Hospital Sakarya, | |
| Samsung Medical Center Seoul, | |
| Seoul National University Bundang Hospital Seongnam-si, | |
| Seoul National University Hospital Seoul, | |
| Shaare Zedek Medical Center Jerusalem, | |
| Shamir Medical Center Assaf Harofeh Be’er Ya‘aqov, | |
| Shengjing Hospital of China Medical University Shenyang, | |
| Sichuan Provincial Peoples Hospital Chengdu, | |
| Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein São Paulo, | |
| St George Hospital Kogarah, New South Wales | |
| St Vincents Hospital Melbourne Fitzroy, | |
| Sun Yat Sen University Cancer Center Guangzhou, | |
| Swedish Cancer Institute Seattle, Washington | |
| Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach Kielce, | |
| Tel Aviv Sourasky Medical Center Tel Aviv, | |
| The Catholic University of Korea Seoul St Marys Hospital Seoul, | |
| The Clatterbridge Cancer Centre Liverpool, | |
| The First Affiliated Hospital Zhejiang University College of Medicine Hangzhou, | |
| The First Affiliated Hospital of Chongqing Medical University Chongqing, | |
| The First Affiliated Hospital of Guangxi Medical University Nanning, | |
| The First Affiliated Hospital of NanChang University Nanchang, | |
| The First Affiliated Hospital of USTC Anhui Provincial Hospital Hefei, | |
| The First Affiliated Hospital of Wenzhou Medical University Wenzhou, | |
| The First Affiliated Hospital of Xiamen University Xiamen, | |
| The Second Affiliated Hospital of Xi'an Jiaotong University Xi'an, | |
| The Second Hospital & Clinical Medical School Lanzhou University Lanzhou, | |
| The Second People's Hospital of Shenzhen Shenzhen, | |
| The first Affiliated Hospital of Jilin University Changchun, | |
| Thomas Jefferson University Philadelphia, Pennsylvania | |
| Tohoku University Hospital Sendai, | |
| Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Bunkyō City, | |
| TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology Wuhan, | |
| UZ Antwerpen Edegem, | |
| Uls Santa Maria Hosp. Santa Maria Lisbon, | |
| Uls Santo Antonio - Hosp. Santo Antonio Porto, | |
| Uls Sao Joao - Hosp. Sao Joao Porto, | |
| Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos Lisbon, | |
| Union Hospital Tongji Medical College of Huazhong University of Science and Technology Wuhan, | |
| UniversitaetsKlinikum Heidelberg Heidelberg, | |
| Universitaetsklinikum Carl Gustav Carus TU Dresden Dresden, | |
| Universitaetsklinikum Frankfurt Frankfurt, | |
| Universitaetsklinikum Hamburg Eppendorf Hamburg, | |
| Universitaetsklinikum Leipzig Leipzig, | |
| Universitaetsklinikum Salzburg Landeskrankenhaus Salzburg, | |
| Universitaetsklinikum Schleswig Holstein Campus Kiel Kiel, | |
| Universitair Ziekenhuis Leuven Leuven, | |
| University General Hospital of Ioannina Ioannina, | |
| University Hospital of Alexandroupolis Alexandroupoli, | |
| University Hospitals Cleveland Medical Center Cleveland, Ohio | |
| University Hospitals Sussex NHS Foundation Trust Worthing, | |
| University Hospitals Sussex NHS Foundation Trust Worthing, | |
| University of Arkansas at Little Rock Little Rock, Arkansas | |
| University of Chicago Medicine Chicago, Illinois | |
| University of Fukui Hospital Yoshida, | |
| University of Kentucky Markey Cancer Center Lexington, Kentucky | |
| University of Pittsburgh Medical Center Pittsburgh, Pennsylvania | |
| University of Rochester Medical Center Rochester, New York | |
| University of Tennessee Knoxville, Tennessee | |
| Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu Wroclaw, | |
| Uniwersytecki Szpital Kliniczny w Bialymstoku Bialystok, | |
| Uniwersyteckie Centrum Kliniczne Gdansk, | |
| UofL Health Brown Cancer Center Louisville, Kentucky | |
| Ustav hematologie a krevni transfuze Prague, | |
| VM Medical Park Mersin Hospital Mersin, | |
| Vancouver General Hospital Vancouver, British Columbia | |
| Vanderbilt Ingram Cancer Center Nashville, Tennessee | |
| Virginia Commonwealth University - Massey Cancer Center Richmond, Virginia | |
| Vseobecna Fakultni Nemocnice Prague, | |
| Washington University in St Louis St Louis, Missouri | |
| West China Hospital Si Chuan University Chengdu, | |
| Western General Hospital Edinburgh, | |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi Lodz, | |
| Yamagata University Hospital Yamagata, | |
| Zealand University Hospital Roskilde, | |
| Zhongda Hospital Southeast University Nanjing, | |
| Ziekenhuis Oost-Limburg Genk, |
MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)
ctrrecruit@vcu.edu
NCT05564390
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Inclusion Criteria:
* Participants must be suspected to have previously untreated acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Participants with AML cannot have a history of previously treated myeloproliferative neoplasms (MPN) or MDS.
* Participants must be \>= 18 years of age.
* Participants must not have received prior anti-cancer therapy for AML or MDS.
* Note: Hydroxyurea to control the white blood cell count (WBC) is allowed.
* Note: Prior erythroid stimulating agent (ESA) is not considered prior therapy for the purposes of eligibility. Participants must not be currently receiving any cytarabine-containing therapy other than up to 1 g/m\^2 of cytarabine, which is allowed for urgent cytoreduction.
* Participants are allowed prior use of hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine kinase inhibitor, erythropoiesis-stimulating agent, thrombopoietin receptor agonist and lenalidomide, with a maximum limit of 1 month of exposure.
* Note: Participants receiving hydroxyurea prior to treatment substudy or TAP assignment must agree to discontinue hydroxyurea within 24 hours before beginning substudy or TAP treatment.
* Participants must not have a prior or concurrent malignancy that requires concurrent anti-cancer therapy
* Note: active hormonal therapy is allowed
* Participants must have a Zubrod Performance Status evaluation within 28 days prior to registration.
* Participants must agree to have translational medicine specimens submitted.
* Participants must be offered the opportunity to participate in specimen banking.
* Note: Specimens must be collected and submitted following the initial paper-based process and subsequently via the Precision Medicine Specimen Tracking Forms in Medidata Rave instance for the MyeloMATCH MSRP.
* 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.
* Note: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.
* The master screening and reassessment protocol (MSRP) should only be used in sites where the relevant AML treatment substudies are open or if the site is willing to follow the MSRP Tier Advancement Pathway (TAP) for patients in the event that the site does not have the relevant study open and transfer to another site that does have the study open. For example, if a site does not have a myeloMATCH Tier 1 study for older AML open for enrollment, such older AML patients should only be consented for the MSRP if the site is willing to treat the patient with standard of care on TAP or is willing to transfer the patient to a center with a study open that the patient would otherwise match to. PROCEDURE: Allogeneic Hematopoietic Stem Cell Transplantation, DRUG: Azacitidine, OTHER: Best Practice, PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, DRUG: Busulfan, PROCEDURE: Chest Radiography, PROCEDURE: Computed Tomography, DRUG: Cytarabine, DRUG: Daunorubicin Hydrochloride, DRUG: Decitabine and Cedazuridine, PROCEDURE: Echocardiography Test, DRUG: Enasidenib, DRUG: Fludarabine, DRUG: Gemtuzumab Ozogamicin, DRUG: Gilteritinib, DRUG: Liposome-encapsulated Daunorubicin-Cytarabine, DRUG: Melphalan, PROCEDURE: Multigated Acquisition Scan, PROCEDURE: Mutation Carrier Screening, DRUG: Olutasidenib, DRUG: Placebo Administration, PROCEDURE: Positron Emission Tomography, RADIATION: Total-Body Irradiation, DRUG: Venetoclax
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm, Acute Myeloid Leukemia Post Cytotoxic Therapy, Acute Myeloid Leukemia, Myelodysplasia-Related, Myelodysplastic Syndrome
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Show 317 locations
Study Locations
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| Location | Contacts |
|---|---|
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Alta Bates Summit Medical Center-Herrick Campus Berkeley, California | Site Public Contact - (clinicalresearch@sutterhealth.org) |
| Arthur J E Child Comprehensive Cancer Centre Calgary, Alberta | Site Public Contact - (ctsucontact@westat.com) |
| 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) |
| BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri | |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| 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 Southhaven, 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) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Ben Taub General Hospital Houston, Texas | |
| 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) |
| CIUSSSEMTL-Hopital Maisonneuve-Rosemont Montreal, Quebec | |
| CSSS Champlain-Charles Le Moyne Greenfield Park, Quebec | |
| 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 Hematology Centers - Flint Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| CancerCare Manitoba Winnipeg, Manitoba | Site Public Contact - (ctu_web@cancercare.mb.ca) |
| 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 | |
| Case Western Reserve University Cleveland, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| Cedars Sinai Medical Center Los Angeles, California | |
| Centro Comprensivo de Cancer de UPR San Juan, | Site Public Contact - (ctsucontact@westat.com) |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Missoula, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Missoula, Montana | Site Public Contact - (Lennette.Gonzales@rwjbh.org) |
| Cooper Hospital University Medical Center Camden, New Jersey | |
| Cotton O'Neil Cancer Center / Stormont Vail Health Topeka, Kansas | |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Duke University Medical Center Durham, North Carolina | |
| Duluth Clinic Ashland Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Edward Hines Jr VA Hospital Hines, Illinois | |
| 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 Virginia Clinic Virginia, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fred Hutchinson Cancer Center Seattle, Washington | |
| Geisinger Medical Center Danville, 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 | |
| Genesys Hurley Cancer Institute Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| George E Wahlen Department of Veterans Affairs Medical Center Salt Lake City, Utah | |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | Site Public Contact - (cancerctr@gundersenhealth.org) |
| 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) |
| HaysMed Hays, Kansas | |
| Heartland Regional Medical Center Saint Joseph, Missouri | Site Public Contact - (Trisha.England2@mymlc.com) |
| Henry Ford Hospital Detroit, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Macomb Hospital-Clinton Township Clinton Township, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Medical Center-Columbus Novi, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford West Bloomfield Hospital West Bloomfield, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Huntsman Cancer Institute/University of Utah Salt Lake City, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| Hurley Medical Center Flint, Michigan | Site Public Contact - (wstrong@ghci.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) |
| Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana | Site Public Contact - (iutrials@iu.edu) |
| 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) |
| Jewish General Hospital Montreal, Quebec | |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Juravinski Cancer Centre at Hamilton Health Sciences Hamilton, Ontario | |
| Kaiser Permanente Downtown Commons Sacramento, California | Site Public Contact - (kpoct@kp.org) |
| Kaiser Permanente Dublin Dublin, California | |
| Kaiser Permanente Fresno Orchard Plaza Fresno, California | |
| Kaiser Permanente Medical Center - Santa Clara Santa Clara, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente Moanalua Medical Center Honolulu, Hawaii | Site Public Contact - (shelley.a.clark@kp.org) |
| Kaiser Permanente San Leandro San Leandro, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Fremont Fremont, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Fresno Fresno, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Modesto Modesto, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Roseville Roseville, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-San Francisco San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Rosa Santa Rosa, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Teresa-San Jose San Jose, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South Sacramento Sacramento, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South San Francisco South San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Vallejo Vallejo, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Walnut Creek Walnut Creek, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser San Rafael-Gallinas San Rafael, California | Site Public Contact - (Kpoct@kp.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| 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 | |
| Lawrence Memorial Hospital Lawrence, Kansas | Site Public Contact - (Stephanie.Norris@LMH.ORG) |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Lewistown Hospital Lewistown, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Logan Health Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Loyola University Medical Center Maywood, Illinois | |
| MaineHealth Cancer Care and IV Therapy - Brunswick Brunswick, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Cancer Care and IV Therapy - South Portland South Portland, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Maine Medical Center - Portland Portland, 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 College of Wisconsin Milwaukee, Wisconsin | |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Memorial Hospital West Pembroke Pines, Florida | |
| Memorial Sloan Kettering Basking Ridge Basking Ridge, New Jersey | |
| Memorial Sloan Kettering Bergen Montvale, New Jersey | |
| 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 Nassau Uniondale, New York | |
| Mercy Hospital Cedar Rapids, Iowa | Site Public Contact - (mmcorc@healthpartners.com) |
| Mercy Hospital South St Louis, Missouri | |
| Mercy Medical Center - Des Moines Des Moines, Iowa | Site Public Contact - (cancerresearch@mercydesmoines.org) |
| Mercyhealth Hospital and Cancer Center - Janesville Janesville, Wisconsin | Site Public Contact - (oncologyclinicaltrials@mhemail.org) |
| Methodist Medical Center of Illinois Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Mid Coast Hospital Brunswick, Maine | Site Public Contact - (ctsucontact@westat.com) |
| 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) |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Mount Sinai Hospital New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Nebraska Medicine-Bellevue Bellevue, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| Nebraska Medicine-Village Pointe Omaha, Nebraska | |
| North Shore University Hospital Manhasset, New York | |
| NorthShore University HealthSystem-Evanston Hospital Evanston, Illinois | |
| NorthShore University HealthSystem-Glenbrook Hospital Glenview, Illinois | |
| NorthShore University HealthSystem-Highland Park Hospital Highland Park, Illinois | |
| Northwell Health/Center for Advanced Medicine Lake Success, New York | |
| 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) |
| Novant Health Forsyth Medical Center Winston-Salem, North Carolina | Site Public Contact - (pjordan@novanthealth.org) |
| Novant Health New Hanover Regional Medical Center Wilmington, North Carolina | |
| Novant Health Presbyterian Medical Center Charlotte, North Carolina | Site Public Contact - (kashah@novanthealth.org) |
| OSF Saint Francis Medical Center Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| OSF Saint Joseph Medical Center Bloomington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Odette Cancer Centre- Sunnybrook Health Sciences Centre Toronto, Ontario | |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| 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) |
| Our Lady of The Lake Baton Rouge, Louisiana | |
| Our Lady of the Lake Physician Group Baton Rouge, Louisiana | Site Public Contact - (research@ololrmc.com) |
| Pali Momi Medical Center ‘Aiea, Hawaii | |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Parkland Health Center - Farmington Farmington, Missouri | |
| Penn State Milton S Hershey Medical Center Hershey, Pennsylvania | Site Public Contact - (CTO@hmc.psu.edu) |
| Phoebe Putney Memorial Hospital Albany, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| 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) |
| ProHealth D N Greenwald Center Mukwonago, Wisconsin | Site Public Contact - (research.institute@phci.org) |
| ProHealth Oconomowoc Memorial Hospital Oconomowoc, Wisconsin | |
| ProHealth Waukesha Memorial Hospital Waukesha, 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 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) |
| QEII Health Sciences Centre/Nova Scotia Health Authority Halifax, Nova Scotia | |
| Reading Hospital West Reading, Pennsylvania | |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Rhode Island Hospital Providence, Rhode Island | |
| Rochester General Hospital Rochester, New York | Site Public Contact - (tia.derosa@rochestergeneral.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 Barnabas Medical Center Livingston, New Jersey | Site Public Contact - (joanne.loeb@rwjbh.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 Patrick Hospital - Community Hospital Missoula, Montana | Site Public Contact - (amy.hanneman@providence.org) |
| 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 | |
| Salina Regional Health Center Salina, Kansas | Site Public Contact - (mleepers@srhc.com) |
| San Juan City Hospital San Juan, | |
| Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicTrialsSF@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| 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) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| State University of New York Upstate Medical University Syracuse, New York | |
| Straub Clinic and Hospital Honolulu, Hawaii | |
| 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 James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky | |
| The University of Kansas Cancer Center - Olathe Olathe, Kansas | Site Public Contact - (OlatheCCResearch@kumc.edu) |
| The Valley Hospital - Luckow Pavilion Paramus, New Jersey | Site Public Contact - (clinicaltrialsresearch@valleyhealth.com) |
| ThedaCare Regional Cancer Center Appleton, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Tibor Rubin VA Medical Center Long Beach, California | |
| 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 Saint Joseph Mercy Hospital Ann Arbor Ann Arbor, 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 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) |
| UCSF Medical Center-Parnassus San Francisco, California | |
| 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 | |
| UMass Memorial Medical Center - University Campus Worcester, Massachusetts | Site Public Contact - (cancer.research@umassmed.edu) |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| 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 Health Network-Princess Margaret Hospital Toronto, Ontario | Site Public Contact - (clinical.trials@uhn.on.ca) |
| University Health Truman Medical Center Kansas City, Missouri | |
| University of Alabama at Birmingham Cancer Center Birmingham, Alabama | Site Public Contact - (gingerreeves@uabmc.edu) |
| University of Alberta Hospital Edmonton, Alberta | Site Public Contact - (pedsoncologyresearch@ahs.ca) |
| University of Arizona Cancer Center-North Campus Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| University of Arkansas for Medical Sciences Little Rock, Arkansas | |
| 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 Illinois Chicago, Illinois | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kansas Cancer Center Kansas City, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - Briarcliff Kansas City, Missouri | |
| University of Kansas Cancer Center - Lee's Summit Lee's Summit, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - North Kansas City, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center-Overland Park Overland Park, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Clinical Research Center Fairway, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Health System Saint Francis Campus Topeka, Kansas | |
| University of Kansas Hospital-Indian Creek Campus Overland Park, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| 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 Pennsylvania/Abramson Cancer Center Philadelphia, Pennsylvania | Site Public Contact - (PMCancerResearch@pennmedicine.upenn.edu) |
| University of Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania | |
| University of Rochester Rochester, New York | |
| University of Tennessee - Knoxville Knoxville, Tennessee | |
| University of Vermont Medical Center Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| University of Vermont and State Agricultural College Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| University of Washington Medical Center - Montlake Seattle, Washington | |
| 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) |
| UofL Health Medical Center Northeast Louisville, Kentucky | Site Public Contact - (ctoinfo@louisville.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Health System Ridgewood Campus Ridgewood, New Jersey | Site Public Contact - (clinicaltrialsresearch@valleyhealth.com) |
| Veterans Affairs Connecticut Healthcare System-West Haven Campus West Haven, Connecticut | |
| 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) |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Walter Reed National Military Medical Center Bethesda, Maryland | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Wayne State University/Karmanos Cancer Institute Detroit, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| Weisberg Cancer Treatment Center Farmington Hills, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| William S Middleton VA Medical Center Madison, Wisconsin | |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study
ctrrecruit@vcu.edu
NCT04269902
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Inclusion Criteria:
* Participants must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (collectively referred to as CLL throughout) according to the 2018 International Workshop on CLL. Participants must have been diagnosed within 18 months prior to registration
* Participants must have CLL-International Prognostic Index (CLL-IPI) score \>= 4 and/or complex cytogenetics (defined as 3+ chromosomal abnormalities)
* Cytogenetic AND/OR FISH analyses must be completed at a Clinical Laboratory Improvement Act (CLIA)-approved (or laboratories accredited under Accreditation Canada Diagnostics to conduct FISH analyses) laboratory within 18 months prior to registration. At minimum, FISH panel should use probes to detect for abnormalities in chromosomes 13q, 12, 11q, and 17p
* TP53 gene mutation analysis performed at any CLIA-approved (or laboratories accredited under Accreditation Canada Diagnostics) lab (if completed) must be obtained within 18 months prior to registration. This sequencing test is distinct from FISH studies for del(17p)
* Note: TP53 gene mutation analysis is recommended but not required if the participant meets disease-related study criteria via a combination of risk factors that totals a score of 4 on the CLL-IPI score and/or has complex cytogenetics completed
* Immunoglobulin heavy chain locus variable (IgVH) gene mutation analysis performed at any CLIA-approved lab (or laboratories accredited under Accreditation Canada Diagnostics) must be obtained prior to registration (at any time prior to registration)
* Serum beta-2 microglobulin level must be obtained within 28 days prior to registration
* Participants must not meet any of the IWCLL specified criteria for active CLL therapy
* Treatment with high dose corticosteroids and/or intravenous immunoglobulin for autoimmune complications of CLL must be complete at least 4 weeks prior to enrollment
* Steroids used for treatment of conditions other than CLL/SLL must be at a dose of at most 20 mg/day of prednisone or equivalent corticosteroid at the time of registration
* Prior therapy with anti CD20 monoclonal antibodies is not allowed
* Participants must not have received or be currently receiving any prior CLL-directed therapy, including non-protocol-related therapy, anti-cancer immunotherapy, experimental therapy (with exception of agents approved for emergency access use for the prevention or treatment of COVID-19), or radiotherapy
* Participants must not be receiving or planning to receive any other investigational agents before completing protocol therapy
* Participants must be \>= 18 years of age
* Participants must have Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
* Platelet count \>= 100,000/mm\^3 within 28 days prior to registration
* Absolute neutrophil count (ANC) \>= 1,000/mm\^3 within 28 days prior to registration
* Creatinine clearance \>= 30mL/min (by Cockcroft Gault) within 28 days prior to registration
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3.0 x upper limit of normal (ULN) within 28 days prior to registration
* Total bilirubin =\< 2.0 x ULN (or 5.0 x ULN if the participant has a history of Gilbert's disease), within 28 days prior to registration
* Participants must be able to take oral medications
* Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
* Participants with history of malignancy are allowed providing the cancer has not required active treatment within 2 years prior to registration (hormonal therapy is permissible). The following exceptions are permissible: basal cell, squamous cell skin, or non-melanomatous skin cancer, in situ cervical cancer, superficial bladder cancer not treated with intravesical chemotherapy or Bacillus Calmette-Guerin (BCG) within 6 months, localized prostate cancer requiring no more than chronic hormonal therapy, or localized breast cancer requiring no more than chronic hormonal therapy
* Participants must not have current, clinically significant gastrointestinal malabsorption, in the opinion of treating doctor
* Participants must not have cirrhosis
* Obinutuzumab has been associated with hepatitis reactivation. Participants must not have uncontrolled active infection with hepatitis B or C. Participants with latent hepatitis B infection must agree to take prophylaxis during and for 6 months following active protocol therapy with V-O.
* Active infection with hepatitis B or C:
* Active infection is defined as detectable hepatitis B deoxyribonucleic acid (DNA) or hepatitis C ribonucleic acid (RNA) by quantitative polymerase chain reaction (PCR).
* Latent infection with hepatitis B:
* Latent infection is defined as meeting all of the following criteria:
* Hepatitis B surface antigen positive
* Anti-hepatitis B total core antibody positive
* Anti-hepatitis IgM core antibody undetectable
* Hepatitis B PCR undetectable
* Participants with latent hepatitis B infection must agree to take prophylaxis with anti-hepatitis agents during and for 6 months following active protocol therapy with V-O.
* Participants who have received intravenous immunoglobulin (IVIG) therapy within 6 months who are hepatitis B core total antibody positive but PCR undetectable are not mandated to take prophylaxis
* Participants must not have had major surgery within 30 days prior registration or minor surgery within 7 days prior to registration. Examples of major surgery include neurosurgical procedures, joint replacements, and surgeries that occur inside the thoracic or abdomino-pelvic cavities. Examples of minor surgery include dental surgery, insertion of a venous access device, skin biopsy, or aspiration of a joint. If a participant has had a bone marrow biopsy for diagnosis or evaluation of CLL, this will not exclude the participant from registration to the study. If there is a question about whether a surgery is major or minor, this should be discussed with the Study Chair
* Participants must not have known bleeding disorders (e.g., von Willebrand's disease or hemophilia)
* Participants must not have a history of stroke or intracranial hemorrhage within 6 months prior to enrollment
* Participants must not require continued therapy with a strong inhibitor or inducer of CYP3A4/5, as venetoclax is extensively metabolized by CYP3A4/5
* Participants must not have uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura
* Participants must not have any currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification
* Participants must not have a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to enrollment
* Participants must not be pregnant or nursing, as there are no safety data available for these drug regimens during pregnancy. Women/men of reproductive potential must have agreed to use an effective contraceptive method. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
* Participants must agree to have specimens submitted for translational medicine (MRD) as outlined
* Participants must be offered the opportunity to participate in specimen banking for future research as outlined.
* NOTE: With participant's consent, the site must follow through with specimen submission as outlined
* Participants who are able to complete patient reported outcome (PRO) forms in English, Spanish, French, German, Russian or Mandarin must agree to participate in the quality of life assessments. (Those participants who are unable to read and write in English, Spanish, French, German, Russian or Mandarin may be registered to S1925 without contributing to the quality of life portion of the study.)
* Participants must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, PROCEDURE: Computed Tomography, BIOLOGICAL: Obinutuzumab, OTHER: Questionnaire Administration, DRUG: Venetoclax
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
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Show 623 locations
Study Locations
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| Location | Contacts |
|---|---|
| Abbott-Northwestern Hospital Minneapolis, Minnesota | |
| Adena Regional Medical Center Chillicothe, Ohio | |
| Advanced Breast Care Center PLLC Warren, Michigan | |
| AdventHealth Littleton Littleton, Colorado | |
| AdventHealth Parker Parker, Colorado | |
| AdventHealth Porter Denver, Colorado | |
| Alaska Breast Care and Surgery LLC Anchorage, Alaska | |
| Alaska Oncology and Hematology LLC Anchorage, Alaska | |
| Alaska Women's Cancer Care Anchorage, Alaska | |
| 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 | |
| Allan Blair Cancer Centre Regina, Saskatchewan | |
| Allegiance Health Jackson, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Anchorage Associates in Radiation Medicine Anchorage, Alaska | |
| Anchorage Oncology Centre Anchorage, Alaska | |
| Anchorage Radiation Therapy Center Anchorage, Alaska | |
| Armes Family Cancer Center Findlay, Ohio | |
| Aspirus Cancer Care - James Beck Cancer Center Rhinelander, Wisconsin | |
| Aspirus Cancer Care - Stevens Point Stevens Point, Wisconsin | |
| Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids, Wisconsin | |
| Aspirus Medford Hospital Medford, Wisconsin | |
| Aspirus Regional Cancer Center Wausau, Wisconsin | |
| Atlantic Health Sciences Corporation-Saint John Regional Hospital Saint John, New Brunswick | |
| Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio | |
| BCCA-Vancouver Cancer Centre Vancouver, British Columbia | |
| BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri | |
| Ballad Health Cancer Care - Bristol Bristol, Virginia | Site Public Contact - (charles.mays@balladhealth.org) |
| Ballad Health Cancer Care - Kingsport Kingsport, Tennessee | Site Public Contact - (charles.mays@balladhealth.org) |
| Ballad Health Cancer Care - Norton Norton, Virginia | Site Public Contact - (charles.mays@balladhealth.org) |
| Banner North Colorado Medical Center Greeley, Colorado | |
| Banner North Colorado Medical Center - Loveland Campus Loveland, Colorado | |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| Baptist Cancer Center-Grenada Grenada, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Desoto Southhaven, 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-Union County New Albany, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Bay Area Hospital Coos Bay, Oregon | |
| Beacon Kalamazoo Kalamazoo, Michigan | |
| Beacon Kalamazoo Cancer Center Kalamazoo, Michigan | |
| Beebe Health Campus Rehoboth Beach, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Beebe Medical Center Lewes, Delaware | |
| Beebe South Coastal Health Campus Millville, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Bellin Memorial Hospital Green Bay, Wisconsin | |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| 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 | |
| Blanchard Valley Hospital Findlay, Ohio | |
| Boulder Community Foothills Hospital Boulder, Colorado | |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Bristol Regional Medical Center Bristol, Tennessee | |
| Broadlawns Medical Center Des Moines, Iowa | |
| 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) |
| CHI Health Good Samaritan Kearney, Nebraska | |
| CHI Saint Vincent Cancer Center Hot Springs Hot Springs, Arkansas | |
| Cambridge Medical Center Cambridge, Minnesota | |
| 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 | |
| Cancer Center of Colorado at Sloan's Lake Denver, Colorado | |
| 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 Partners of Nebraska Lincoln, Nebraska | |
| 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) |
| 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 | |
| Central Care Cancer Center - Bolivar Bolivar, Missouri | |
| Central Care Cancer Center - Garden City Garden City, Kansas | |
| Central Care Cancer Center - Great Bend Great Bend, Kansas | |
| Central Ohio Breast and Endocrine Surgery Gahanna, Ohio | |
| Centralia Oncology Clinic Centralia, Illinois | |
| Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Cheyenne Regional Medical Center-West Cheyenne, Wyoming | |
| Christiana Care Health System-Christiana Hospital Newark, Delaware | |
| Christiana Care Health System-Concord Health Center Chadds Ford, Pennsylvania | |
| Christiana Care Health System-Wilmington Hospital Wilmington, Delaware | |
| 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 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 | |
| Clackamas Radiation Oncology Center Clackamas, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| 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) |
| Cleveland Clinic Mercy Hospital Canton, Ohio | |
| Coborn Cancer Center at Saint Cloud Hospital Saint Cloud, Minnesota | Site Public Contact - (coborncancercenter@centracare.com) |
| Colorado Blood Cancer Institute Denver, Colorado | |
| 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 Missoula, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Missoula, Montana | Site Public Contact - (Lennette.Gonzales@rwjbh.org) |
| Cooper Hospital University Medical Center Camden, New Jersey | |
| 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 | |
| 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 | |
| Corewell Health Reed City Hospital Reed City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| 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 | |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Dayton Physician LLC - Englewood Dayton, Ohio | |
| Dayton Physicians LLC - Troy Troy, Ohio | |
| Dayton Physicians LLC-Atrium Franklin, Ohio | |
| Dayton Physicians LLC-Miami Valley South Centerville, Ohio | |
| Dayton Physicians LLC-Wayne Greenville, Ohio | |
| Decatur Memorial Hospital Decatur, Illinois | |
| Delaware Clinical and Laboratory Physicians PA Newark, Delaware | |
| Delaware Health Center-Grady Cancer Center Delaware, Ohio | |
| Doctors Hospital Columbus, Ohio | |
| Dublin Methodist Hospital Dublin, Ohio | |
| Duke University Medical Center Durham, North Carolina | |
| Duluth Clinic Ashland Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Durham VA Medical Center Durham, North Carolina | |
| ECU Health Oncology Kenansville Kenansville, North Carolina | |
| ECU Health Oncology Kinston Kinston, North Carolina | Site Public Contact - (research@ecuhealth.org) |
| ECU Health Oncology Richlands Richlands, North Carolina | |
| Edward Hospital/Cancer Center Naperville, Illinois | |
| Edward Hospital/Cancer Center?Plainfield Plainfield, Illinois | Site Public Contact - (Cancerresearch@edward.org) |
| Elmhurst Memorial Hospital Elmhurst, Illinois | Site Public Contact - (Jrohde@emhc.org) |
| 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) |
| FHCC Overlake Bellevue, Washington | |
| FHCC at EvergreenHealth Kirkland, Washington | |
| FHCC at Northwest Hospital Seattle, Washington | |
| Fairbanks Memorial Hospital Fairbanks, Alaska | |
| Fairfield Medical Center Lancaster, Ohio | |
| Fairview Clinics and Surgery Center Maple Grove Maple Grove, Minnesota | |
| Fairview Lakes Medical Center Wyoming, Minnesota | |
| Fairview Northland Medical Center Princeton, Minnesota | |
| Fairview Ridges Hospital Burnsville, Minnesota | |
| Fairview Southdale Hospital Edina, Minnesota | |
| Flaget Memorial Hospital Bardstown, Kentucky | |
| Franciscan Research Center-Northwest Medical Plaza Tacoma, Washington | |
| Fred Hutchinson Cancer Center Seattle, Washington | |
| Freeman Health System Joplin, Missouri | |
| Fremont - Rideout Cancer Center Marysville, California | |
| Geisinger Medical Center Danville, 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 | |
| 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) |
| Glens Falls Hospital Glens Falls, New York | |
| Good Samaritan Hospital - Cancer Centers of Colorado Lafayette, Colorado | |
| 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 | |
| Greater Dayton Cancer Center Kettering, Ohio | |
| Greater Regional Medical Center Creston, Iowa | |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | |
| HSHS Sacred Heart Hospital Eau Claire, Wisconsin | |
| Harold Alfond Center for Cancer Care Augusta, Maine | |
| Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo, Washington | |
| HaysMed Hays, Kansas | |
| Health Partners Inc Minneapolis, Minnesota | |
| Heartland Regional Medical Center Saint Joseph, Missouri | |
| 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) |
| Hematology/Oncology Clinic PLLC Baton Rouge, Louisiana | |
| Hennepin County Medical Center Minneapolis, Minnesota | |
| Henry Ford Cancer Institute-Downriver Brownstown, Michigan | |
| Henry Ford Health Providence Southfield Hospital Southfield, Michigan | Site Public Contact - (kfife3@hfhs.org) |
| 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 Hospital Detroit, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Macomb Health Center - Shelby Township Shelby, Michigan | |
| Henry Ford Macomb Hospital-Clinton Township Clinton Township, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Madison Heights Hospital - Breast Warren, Michigan | |
| Henry Ford Medical Center-Columbus Novi, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Medical Center-Fairlane Dearborn, Michigan | |
| Henry Ford River District Hospital East China Township, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| 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 | |
| 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 | |
| Henry Ford Warren Hospital - GLCMS Warren, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford West Bloomfield Hospital West Bloomfield, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Hickman Cancer Center Adrian, Michigan | |
| Highline Medical Center-Main Campus Burien, Washington | |
| Hillcrest Hospital Cancer Center Mayfield Heights, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Holy Cross Hospital Fort Lauderdale, Florida | Site Public Contact - (eileen.georgi@holy-cross.com) |
| Hope Cancer Center Pontiac, Michigan | |
| Hope Cancer Clinic Livonia, Michigan | |
| Huntsman Cancer Institute/University of Utah Salt Lake City, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| 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 | |
| Illinois CancerCare - Washington Washington, Illinois | |
| Illinois CancerCare-Bloomington Bloomington, Illinois | |
| Illinois CancerCare-Canton Canton, Illinois | |
| Illinois CancerCare-Carthage Carthage, Illinois | |
| Illinois CancerCare-Dixon Dixon, Illinois | |
| Illinois CancerCare-Eureka Eureka, Illinois | |
| Illinois CancerCare-Galesburg Galesburg, Illinois | |
| Illinois CancerCare-Kewanee Clinic Kewanee, Illinois | |
| Illinois CancerCare-Macomb Macomb, Illinois | |
| Illinois CancerCare-Ottawa Clinic Ottawa, Illinois | |
| Illinois CancerCare-Pekin Pekin, Illinois | |
| Illinois CancerCare-Peoria Peoria, Illinois | |
| Illinois CancerCare-Peru Peru, Illinois | |
| Illinois CancerCare-Princeton Princeton, Illinois | |
| Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana | Site Public Contact - (iutrials@iu.edu) |
| Indu and Raj Soin Medical Center Beavercreek, Ohio | |
| Ingalls Memorial Hospital Harvey, Illinois | Site Public Contact - (clinicaltrials@ingalls.org) |
| Iowa Lutheran Hospital Des Moines, Iowa | |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| Jefferson Healthcare Port Townsend, Washington | |
| Jefferson Torresdale Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Jersey City Medical Center Jersey City, New Jersey | Site Public Contact - (ctsucontact@westat.com) |
| Jewish General Hospital Montreal, Quebec | |
| Jewish Hospital Louisville, Kentucky | |
| Jewish Hospital Medical Center South Shepherdsville, Kentucky | |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kadlec Clinic Hematology and Oncology Kennewick, Washington | Site Public Contact - (research@kadlecmed.org) |
| Kaiser Permanente - Panorama City Panorama City, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente Los Angeles Medical Center Los Angeles, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente South Bay Harbor City, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente West Los Angeles Los Angeles, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Anaheim Anaheim, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Baldwin Park Baldwin Park, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Bellflower Bellflower, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Fontana Fontana, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Irvine Irvine, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Ontario Ontario, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Riverside Riverside, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-San Diego Zion San Diego, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-San Marcos San Marcos, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Woodland Hills Woodland Hills, California | Site Public Contact - (clinical.trials@kp.org) |
| Katmai Oncology Group Anchorage, Alaska | |
| Kettering Medical Center Kettering, Ohio | |
| Knox Community Hospital Mount Vernon, Ohio | |
| 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 Sciences Center at Shreveport Shreveport, Louisiana | |
| Lakeridge Health Oshawa Oshawa, Ontario | |
| Lakeview Hospital Stillwater, Minnesota | |
| Langlade Hospital and Cancer Center Antigo, Wisconsin | |
| Lawrence Memorial Hospital Lawrence, Kansas | Site Public Contact - (Stephanie.Norris@LMH.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 | |
| 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 | |
| Loyola Center for Health at Burr Ridge Burr Ridge, Illinois | |
| Loyola Medicine Homer Glen Homer Glen, Illinois | |
| Loyola University Medical Center Maywood, Illinois | |
| MD Anderson Cancer Center at Cooper-Voorhees Voorhees Township, New Jersey | |
| MU Health Care Goldschmidt Cancer Center Jefferson City, Missouri | |
| Macomb Hematology Oncology PC Warren, Michigan | |
| MaineHealth Cancer Care and IV Therapy - South Portland South Portland, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Maine Medical Center - Portland Portland, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| 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) |
| Marjorie Weinberg Cancer Center at Loyola-Gottlieb Melrose Park, Illinois | |
| Marshall Cancer Center Cameron Park, California | Site Public Contact - (cancerservices@marshallmedical.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) |
| Mary Greeley Medical Center Ames, Iowa | |
| McFarland Clinic - Ames Ames, Iowa | Site Public Contact - (ksoder@mcfarlandclinic.com) |
| McFarland Clinic - Boone Boone, Iowa | |
| McFarland Clinic - Jefferson Jefferson, Iowa | |
| McFarland Clinic - Marshalltown Marshalltown, Iowa | |
| McFarland Clinic - Trinity Cancer Center Fort Dodge, Iowa | |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| Medical Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Memorial Hospital Chattanooga, Tennessee | Site Public Contact - (Jeffh@columbusccop.org) |
| Memorial Hospital of Carbondale Carbondale, Illinois | |
| Memorial Medical Center-Las Cruces Las Cruces, New Mexico | Site Public Contact - (Deborah.Brown@LPNT.net) |
| Memorial Sloan Kettering Basking Ridge Basking Ridge, New Jersey | |
| Memorial Sloan Kettering Bergen Montvale, New Jersey | |
| 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 Nassau Uniondale, New York | |
| Memorial Sloan Kettering Westchester Harrison, New York | |
| 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 - Perrysburg Hospital Perrysburg, Ohio | |
| Mercy Health - Saint Anne Hospital Toledo, Ohio | |
| Mercy Health - Saint Vincent Hospital Toledo, Ohio | |
| Mercy Hospital Cedar Rapids, Iowa | Site Public Contact - (mmcorc@healthpartners.com) |
| Mercy Hospital Fort Smith Fort Smith, Arkansas | |
| Mercy Hospital Joplin Joplin, Missouri | |
| 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 - Des Moines Des Moines, Iowa | Site Public Contact - (cancerresearch@mercydesmoines.org) |
| Mercy Medical Center-West Lakes West Des Moines, Iowa | |
| Mercy Oncology and Hematology - Clayton-Clarkson Ballwin, Missouri | |
| Mercy San Juan Medical Center Carmichael, California | |
| Methodist Medical Center of Illinois Peoria, Illinois | |
| Methodist West Hospital West Des Moines, Iowa | |
| Miami Valley Hospital Dayton, Ohio | |
| Miami Valley Hospital North Dayton, Ohio | |
| Miami Valley Hospital South Centerville, Ohio | |
| Michigan Healthcare Professionals Pontiac Pontiac, Michigan | Site Public Contact - (Emily.Crofts@trinity-health.org) |
| Mid Coast Hospital Brunswick, Maine | Site Public Contact - (ctsucontact@westat.com) |
| Midlands Community Hospital Papillion, Nebraska | |
| Minneapolis VA Medical Center Minneapolis, Minnesota | |
| Minnesota Oncology - Burnsville Burnsville, Minnesota | |
| Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota | |
| Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota | |
| 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 | |
| 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) |
| Monticello Cancer Center Monticello, Minnesota | |
| Mount Carmel East Hospital Columbus, Ohio | |
| Mount Carmel Grove City Hospital Grove City, Ohio | |
| Mount Carmel Health Center West Columbus, Ohio | |
| Mount Sinai Hospital New York, New York | |
| Mountain Blue Cancer Care Center - Swedish Englewood, Colorado | |
| 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) |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York | |
| National Jewish Health-Main Campus Denver, Colorado | |
| National Jewish Health-Northern Hematology Oncology Thornton, Colorado | |
| National Jewish Health-Western Hematology Oncology Golden, Colorado | |
| Nebraska Cancer Specialists/Oncology Hematology West PC Grand Island, Nebraska | |
| New Ulm Medical Center New Ulm, Minnesota | |
| Newark Radiation Oncology Newark, Ohio | |
| 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 | |
| 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 | |
| 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 University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| OSF Saint Anthony's Health Center Alton, Illinois | |
| Ochsner LSU Health Monroe Medical Center Monroe, Louisiana | |
| Ochsner LSU Health Saint Mary's Medical Center Shreveport, Louisiana | |
| 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 | |
| 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) |
| Orion Cancer Care Findlay, Ohio | |
| Ottawa Hospital and Cancer Center-General Campus Ottawa, Ontario | |
| 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 | |
| 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 | |
| Penrose-Saint Francis Healthcare Colorado Springs, Colorado | |
| Phelps Health Delbert Day Cancer Institute Rolla, Missouri | Site Public Contact - (research@phelpshealth.org) |
| Physicians' Clinic of Iowa PC Cedar Rapids, Iowa | |
| Pocono Medical Center East Stroudsburg, Pennsylvania | |
| Presbyterian - Saint Lukes Medical Center - Health One Denver, Colorado | |
| Presbyterian Kaseman Hospital Albuquerque, New Mexico | |
| 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 | 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) |
| ProMedica Flower Hospital Sylvania, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| Providence Alaska Medical Center Anchorage, Alaska | |
| Providence Cancer Institute Clackamas Clinic Clackamas, Oregon | |
| 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 | |
| Providence Regional Cancer System-Aberdeen Aberdeen, Washington | |
| Providence Regional Cancer System-Centralia Centralia, Washington | |
| Providence Regional Cancer System-Lacey Lacey, Washington | |
| 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 | |
| Providence Saint Mary Regional Cancer Center Walla Walla, Washington | |
| 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) |
| QEII Health Sciences Centre/Nova Scotia Health Authority Halifax, Nova Scotia | |
| Ralph H Johnson VA Medical Center Charleston, South Carolina | Site Public Contact - (ashley.salvo@va.gov) |
| Regions Hospital Saint Paul, Minnesota | |
| Reid Health Richmond, Indiana | |
| Rice Memorial Hospital Willmar, Minnesota | |
| Ridgeview Medical Center Waconia, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Riverside Methodist Hospital Columbus, Ohio | |
| Rochester General Hospital Rochester, New York | |
| Rocky Mountain Cancer Centers - Centennial Centennial, Colorado | |
| Rocky Mountain Cancer Centers - Swedish Englewood, Colorado | |
| Rocky Mountain Cancer Centers-Aurora Aurora, Colorado | |
| Rocky Mountain Cancer Centers-Boulder Boulder, Colorado | |
| Rocky Mountain Cancer Centers-Lakewood Lakewood, Colorado | |
| Rocky Mountain Cancer Centers-Littleton Littleton, Colorado | |
| Rocky Mountain Cancer Centers-Longmont Longmont, Colorado | |
| Rocky Mountain Cancer Centers-Midtown Denver, Colorado | |
| Rocky Mountain Cancer Centers-Penrose Colorado Springs, Colorado | |
| Rocky Mountain Cancer Centers-Rose Denver, Colorado | |
| Rocky Mountain Cancer Centers-Sky Ridge Lone Tree, Colorado | |
| Rocky Mountain Cancer Centers-Thornton Thornton, Colorado | |
| Rose Medical Center Denver, Colorado | |
| 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) |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| SIH Cancer Institute Carterville, Illinois | |
| SSM Health Good Samaritan Mount Vernon, Illinois | |
| STCC at DHR Health Institute for Research and Development Edinburg, Texas | Site Public Contact - (dhrresearch@dhr-rgv.com) |
| SUNY Upstate Medical Center-Community Campus Syracuse, New York | |
| Sacred Heart Hospital Pensacola, Florida | |
| Saint Alphonsus Cancer Care Center-Baker City Baker City, Oregon | |
| 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 | |
| Saint Anthony Hospital Lakewood, Colorado | |
| Saint Anthony Regional Hospital Carroll, Iowa | |
| Saint Charles Health System Bend, Oregon | Site Public Contact - (nosall@stcharleshealthcare.org) |
| Saint Charles Health System-Redmond Redmond, Oregon | |
| Saint Clare Hospital Lakewood, Washington | |
| Saint Elizabeth Boardman Hospital Boardman, Ohio | |
| Saint Elizabeth Hospital Enumclaw, Washington | |
| Saint Elizabeth Regional Medical Center Lincoln, Nebraska | |
| Saint Elizabeth Youngstown Hospital Youngstown, Ohio | |
| Saint Francis Hospital Federal Way, Washington | |
| 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's Hospital - Healtheast Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint Joseph Hospital - Cancer Centers of Colorado Denver, Colorado | |
| Saint Joseph Hospital East Lexington, Kentucky | |
| Saint Joseph London London, Kentucky | |
| Saint Joseph Radiation Oncology Resource Center Lexington, Kentucky | |
| Saint Joseph Regional Cancer Center Bryan, Texas | |
| Saint Joseph Warren Hospital Warren, Ohio | |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | |
| Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho | |
| Saint Luke's Cancer Institute - Meridian Meridian, Idaho | |
| Saint Luke's Cancer Institute - Nampa Nampa, Idaho | |
| Saint Luke's Cancer Institute - Twin Falls Twin Falls, Idaho | |
| Saint Luke's Hospital Chesterfield, Missouri | |
| Saint Mary Corwin Medical Center Pueblo, Colorado | |
| Saint Mary's Hospital and Regional Medical Center Grand Junction, Colorado | |
| Saint Mary's Oncology/Hematology Associates of Marlette Marlette, Michigan | |
| Saint Mary's Oncology/Hematology Associates of West Branch West Branch, Michigan | |
| Saint Michael Cancer Center Silverdale, Washington | |
| Saint Patrick Hospital - Community Hospital Missoula, Montana | |
| Saint Rita's Medical Center Lima, Ohio | |
| Saint Vincent Frontier Cancer Center Billings, Montana | |
| Saint Vincent Healthcare Billings, Montana | |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | |
| Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin | |
| Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin | |
| Saint Vincent Hospital Cancer Center at Sheboygan Sheboygan, Wisconsin | |
| Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri | |
| Saints Mary and Elizabeth Hospital Louisville, Kentucky | |
| Salina Regional Health Center Salina, Kansas | Site Public Contact - (mleepers@srhc.com) |
| Sibley Memorial Hospital Washington D.C., District of Columbia | Site Public Contact - (jquiver1@jhmi.edu) |
| Siteman Cancer Center at Christian Hospital St Louis, Missouri | |
| Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri | |
| Siteman Cancer Center at West County Hospital Creve Coeur, Missouri | |
| Siteman Cancer Center-South County St Louis, Missouri | |
| Sky Ridge Medical Center Lone Tree, Colorado | |
| 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 | |
| Springfield Regional Cancer Center Springfield, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Springfield Regional Medical Center Springfield, Ohio | |
| Stanford Cancer Institute Palo Alto Palo Alto, California | |
| State University of New York Upstate Medical University Syracuse, New York | |
| Strecker Cancer Center-Belpre Belpre, Ohio | Site Public Contact - (Jeffh@columbusccop.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 Englewood, Colorado | |
| Swedish Medical Center-Ballard Campus Seattle, Washington | |
| Swedish Medical Center-Cherry Hill Seattle, Washington | |
| Swedish Medical Center-First Hill Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| The Carle Foundation Hospital Urbana, Illinois | |
| The Mark H Zangmeister Center Columbus, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| The Medical Center of Aurora Aurora, Colorado | |
| The Melanoma and Skin Cancer Institute Englewood, Colorado | |
| The University of Kansas Cancer Center - Olathe Olathe, Kansas | Site Public Contact - (OlatheCCResearch@kumc.edu) |
| The Women's Imaging Center Denver, Colorado | |
| ThedaCare Regional Cancer Center Appleton, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Tibor Rubin VA Medical Center Long Beach, California | |
| TidalHealth Nanticoke / Allen Cancer Center Seaford, Delaware | |
| Toledo Clinic Cancer Centers-Monroe Monroe, Michigan | |
| Toledo Clinic Cancer Centers-Toledo Toledo, Ohio | |
| TriHealth Cancer Institute-Anderson Cincinnati, Ohio | |
| TriHealth Cancer Institute-Westside Cincinnati, 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) |
| Tulane University School of Medicine New Orleans, Louisiana | |
| UC Comprehensive Cancer Center at Silver Cross New Lenox, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| UC Irvine Health Cancer Center-Newport Costa Mesa, California | |
| 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) |
| UChicago Medicine Northwest Indiana Crown Point, Indiana | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| 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 | |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive, Iowa | |
| UI Healthcare Mission Cancer and Blood - Fort Dodge Fort Dodge, Iowa | |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| UT Southwestern Clinical Center at Richardson/Plano Richardson, Texas | |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | |
| UW Health Carbone Cancer Center Rockford Rockford, Illinois | Site Public Contact - (lkline@uwhealth.org) |
| United Hospital Saint Paul, Minnesota | |
| Unity Hospital Fridley, Minnesota | |
| University Health Truman Medical Center Kansas City, Missouri | |
| University of Alabama at Birmingham Cancer Center Birmingham, Alabama | |
| University of Arizona Cancer Center-North Campus Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.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 Chicago Medicine-Orland Park Orland Park, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Cincinnati Cancer Center-UC Medical Center Cincinnati, Ohio | |
| University of Cincinnati Cancer Center-West Chester West Chester, Ohio | |
| University of Kansas Cancer Center Kansas City, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - Briarcliff Kansas City, Missouri | |
| University of Kansas Cancer Center - Lee's Summit Lee's Summit, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - North Kansas City, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center-Overland Park Overland Park, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Health System Saint Francis Campus Topeka, Kansas | |
| University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas | Site Public Contact - (KUCC_Navigation@kumc.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 New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| University of North Carolina-Hillsborough Campus Hillsborough, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.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 Rochester Rochester, New York | |
| University of Washington Medical Center - Montlake Seattle, Washington | |
| 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) |
| UofL Health Medical Center Northeast Louisville, Kentucky | |
| Upper Valley Medical Center Troy, Ohio | |
| 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) |
| 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 Radiation Oncology Peru, Illinois | |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Walter Knox Memorial Hospital Emmett, Idaho | |
| Walter Reed National Military Medical Center Bethesda, Maryland | |
| Washington University School of Medicine St Louis, Missouri | |
| Wayne Hospital Greenville, Ohio | |
| Welch Cancer Center Sheridan, Wyoming | |
| Wellmont Holston Valley Hospital and Medical Center Kingsport, Tennessee | |
| West Michigan Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Western Illinois Cancer Treatment Center Galesburg, Illinois | |
| Western Surgical Care Denver, Colorado | |
| Wilmot Cancer Institute at Webster Webster, New York | Site Public Contact - (WCICTOresearch@urmc.rochester.edu) |
| Woodland Memorial Hospital Woodland, California | |
| Wright-Patterson Medical Center Wright-Patterson Air Force Base, Ohio | |
| Zablocki Veterans Administration Medical Center Milwaukee, Wisconsin |
Caring and Coping with Cancer (C3) (C3)
Winter, Marcia - mawinter@vcu.edu
Winter, Marcia
14620
HM20014307
Lymphoid Leukemia, Multiple Myeloma, Myeloid and Monocytic Leukemia, Non-Hodgkin's Lymphoma
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Winter, Marcia - (mawinter@vcu.edu) |
A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)
ctrrecruit@vcu.edu
NCT06124157
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Inclusion Criteria:
* Patients must be \> 365 days and \< 18 years (for AIEOP-BFM), \> 365 days and \< 22 years (for Children's Oncology Group \[COG\]) and \> 365 days and \< 46 years (for ALLTogether sites) at the time of enrollment
* Newly-diagnosed Ph+ or ABL-class Ph-like B-ALL. Leukemic blasts must express CD19. ABL-class fusions are defined as rearrangements involving the following genes predicted to be sensitive to imatinib and/or dasatinib: ABL1, ABL2, CSF1R, and PDGFRB
* Evidence of BCR::ABL1 should be documented by a clinically-validated assay prior to study entry on day 15 from the first dose of vinCRIStine during Induction therapy. ABL-class Ph-like B-ALL gene rearrangements should be documented by a clinically-validated assay and enrolled on study by day 1 of Blinatumomab Block 1. Accepted methods of detection include fluorescence in situ hybridization (FISH) using break-apart of colocalization signal probes, singleplex or multiplex reverse-transcription polymerase chain reaction (RT-PCR), whole-transcriptome or panel-based ribonucleic acid (RNA) sequencing (e.g., Hematologic Cancer Fusion Analysis, TruSight RNA Pan-Cancer Panel or equivalent). Confirmation of 5' fusion partner genes is not required for study enrollment
* Patients with Ph+ B-ALL must have previously started Induction therapy, which includes vinCRIStine, a corticosteroid, pegaspargase or calaspargase pegol, with or without anthracycline, and/or other standard cytotoxic chemotherapy
* Patients with Ph+ B-ALL have not received more than 14 days of systemic Induction therapy beginning with the first Induction dose of vinCRIStine
* Patients with ABL-class Ph-like B-ALL must have previously completed 4 or 5 weeks of multiagent Induction chemotherapy (Induction 1A)
* Patients may have started either imatinib or dasatinib prior to study entry but should have received no more than 14 days of TKI for Ph+ B-ALL or no more than 35 days of TKI for ABL-class Ph-like B-ALL
* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of ≤ 2 or Karnofsky and Lansky performance scores ≥ 50%. Use Karnofsky for patients \> 16 years of age and Lansky for patients ≤ 16 years of age
* For pediatric patients (age 1-17 years): a glomerular filtration rate (GFR) ≥ 50 mL/min/1.73 m\^2, as determined by one of the following methods (must be performed within 7 days prior to enrollment unless otherwise indicated):
* Estimated GFR (eGFR) ≥ 50 mL/min/1.73 m2
* Measured GFR ≥ 50 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
* For adult patients (age 18 years or older): Creatinine clearance ≥ 30 mL/min, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on body weight
* Direct bilirubin \< 2.0 mg/dL (34.2 micromoles/L) (must be performed within 7 days prior to enrollment unless otherwise indicated)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 10 x upper limit of normal (ULN) (must be performed within 7 days prior to enrollment unless otherwise indicated)
* \* Shortening fraction of ≥ 27% by echocardiogram (must be obtained within 21 days prior to enrollment and start of protocol therapy \[repeat if necessary\]) OR
* Left Ventricular Ejection fraction of ≥ 50% by radionuclide angiogram or echocardiogram (must be obtained within 21 days prior to enrollment and start of protocol therapy \[repeat if necessary\]) AND
* Corrected QT Interval, QTc \< 480mSec (must be obtained within 21 days prior to enrollment and start of protocol therapy \[repeat if necessary\])
* Note: Repeat echocardiogram and electrocardiogram are not required if they were performed at or after initial ALL diagnosis before study enrollment
Exclusion Criteria:
* Known history of chronic myeloid leukemia (CML)
* ABL-class Ph-like B-ALL who are CNS2 or CNS3 at end of Induction phase
* ALL developing after a previous cancer treated with cytotoxic chemotherapy
* Active, uncontrolled infection or active systemic illness that requires ongoing vasopressor support or mechanical ventilation
* Down syndrome (trisomy 21)
* Pregnancy and breast feeding
* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A negative pregnancy test is required for female patients of childbearing potential within 7 days prior to enrollment
* Lactating females who plan to breastfeed their infants
* Sexually active male and female patients of reproductive potential who have not agreed to use an effective contraception method for the duration of treatment according to protocol
* NOTE: Patients who could become pregnant or could father a child must use effective contraception during protocol treatment and for 30 days after the last dose of dasatinib or 14 days after the last dose of imatinib dose or per institutional standard of care for multiagent chemotherapy, whichever is longer
* Prior treatment with TKIs before study entry with the exception of imatinib or dasatinib
* Patients with congenital long QT syndrome, history of ventricular arrhythmias, or heart block
* Patients with known Charcot-Marie-Tooth disease
* Patients with significant central nervous system pathology that would preclude treatment with blinatumomab, including history of severe neurologic disorder or autoimmune disease with central nervous system (CNS) involvement
* Note: Patients with a history of seizures that are well controlled on stable doses of anti-epileptic drugs are eligible. Patients with a history of cerebrovascular ischemia/hemorrhage with residual deficits are not eligible. Patients with a history of cerebrovascular ischemia/hemorrhage remain eligible provided all neurologic deficits have resolved
* HIV-infected patients are eligible if on effective anti-retroviral therapy that does not interact with planned study agents and with undetectable viral load within 6 months of treatment
* 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: Blinatumomab, PROCEDURE: Bone Marrow Biopsy, DRUG: Calaspargase Pegol, DRUG: Cyclophosphamide, DRUG: Cytarabine, DRUG: Dasatinib, DRUG: Daunorubicin, DRUG: Doxorubicin, PROCEDURE: Echocardiography Test, DRUG: Imatinib, DRUG: Leucovorin, DRUG: Mercaptopurine, DRUG: Methotrexate, PROCEDURE: Multigated Acquisition Scan, DRUG: Pegaspargase, DRUG: Prednisolone, DRUG: Prednisone, RADIATION: Radiation Therapy, DRUG: Thioguanine, DRUG: Vincristine
B Acute Lymphoblastic Leukemia
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| Location | Contacts |
|---|---|
| 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) |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Arnold Palmer Hospital for Children Orlando, Florida | Site Public Contact - (Jennifer.spinelli@orlandohealth.com) |
| 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) |
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| British Columbia Children's Hospital Vancouver, British Columbia | |
| 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, | Site Public Contact - (rechclinique@crchudequebec.ulaval.ca) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| 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 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 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 Mercy Hospitals and Clinics Kansas City, Missouri | Site Public Contact - (COGResearchGroup@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) |
| 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) |
| Covenant Children's Hospital Lubbock, Texas | Site Public Contact - (mbisbee@providence.org) |
| 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) |
| Driscoll Children's Hospital Corpus Christi, Texas | Site Public Contact - (Crystal.DeLosSantos@dchstx.org) |
| Duke University Medical Center Durham, North Carolina | |
| East Tennessee Childrens Hospital Knoxville, Tennessee | |
| El Paso Children's Hospital El Paso, Texas | Site Public Contact - (ranjan.bista@ttuhsc.edu) |
| Golisano Children's Hospital of Southwest Florida Fort Myers, Florida | Site Public Contact - (molly.arnstrom@leehealth.org) |
| 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) |
| Inova Fairfax Hospital Falls Church, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Johns Hopkins All Children's Hospital St. Petersburg, Florida | Site Public Contact - (Ashley.Repp@jhmi.edu) |
| 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) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| 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 | |
| Maine Children's Cancer Program Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Mary Bridge Children's Hospital and Health Center Tacoma, Washington | Site Public Contact - (research@multicare.org) |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| McMaster Children's Hospital at Hamilton Health Sciences Hamilton, Ontario | |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| Medical City Dallas Hospital Dallas, Texas | |
| Memorial Health University Medical Center Savannah, Georgia | Site Public Contact - (Lorraine.OHara@hcahealthcare.com) |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (OHR@mhs.net) |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| 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 | |
| Mission Hospital Asheville, North Carolina | Site Public Contact - (NCDV.ResearchRegulatory@HCAHealthcare.com) |
| Morristown Medical Center Morristown, New Jersey | |
| NYU Langone Hospital - Long Island Mineola, New York | Site Public Contact - (cancertrials@nyulangone.org) |
| Nemours Children's Clinic - Pensacola Pensacola, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Nemours Children's Clinic-Jacksonville Jacksonville, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| New York Medical College Valhalla, New York | |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Penn State Children's Hospital Hershey, Pennsylvania | |
| Perth Children's Hospital Perth, Western Australia | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Phoenix Childrens Hospital Phoenix, Arizona | |
| 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) |
| 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) |
| 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 Regional Medical Center Paterson, New Jersey | Site Public Contact - (HallL@sjhmc.org) |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.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 Children's Hospital at TriStar Centennial Nashville, Tennessee | |
| The Montreal Children's Hospital of the MUHC Montreal, Quebec | Site Public Contact - (info@thechildren.com) |
| UCSF Benioff Children's Hospital Oakland Oakland, California | Site Public Contact - (PedOncRschOAK@ucsf.edu) |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UF Health Cancer Institute - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.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 Pediatric Hospital San Juan, | |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Illinois Chicago, Illinois | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Texas Health Science Center at San Antonio San Antonio, Texas | Site Public Contact - (phoresearchoffice@uthscsa.edu) |
| University of Vermont and State Agricultural College Burlington, Vermont | Site Public Contact - (rpo@uvm.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) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Walter Reed National Military Medical Center Bethesda, Maryland | |
| 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) |
Phase 1 Study of Shattuck Labs (SL)-172154 in Subjects With MDS or AML
Shattuck Clinical Trials - clinicaltrials@shattucklabs.com
NCT05275439
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Inclusion Criteria:
• Subject has voluntarily agreed to participate by giving written informed consent in accordance with International Council for Harmonisation/Good Clinical Practice (ICH/GCP) guidelines and applicable local regulations.
• Age ≥ 18 years.
• For subjects with AML, confirmation of AML diagnosis by 2016 World Health Organization (WHO) criteria [Arber, 2016] classification, excluding acute promyelocytic leukemia (APL).
• Subjects with MDS must have:
• morphologically confirmed diagnosis of MDS by 2016 WHO criteria [Arber, 2016] with <20% blasts in bone marrow per bone marrow biopsy/aspirate or peripheral blood.
• confirmation of intermediate, high or very high risk category by Revised International Prognostic Scoring System (IPSS-R)
• Subjects with AML must have relapsed/refractory disease (>5% blasts by manual aspirate differential, flow cytometry, or immunohistochemistry) following at least 1 prior line of therapy but no more than 4 prior lines of therapy.
• Subjects with relapsed/refractory disease (as defined in Inclusion criterion 5) following at least 1 prior line of therapy but no more than 4 prior lines of therapy for AML or MDS.
• Subjects diagnosed with MDS must be previously untreated. Prior MDS therapy with lenalidomide or supportive care in the form of transfusions or growth factors is allowed.
• All subjects must have documentation of at least one tumor protein 53 (TP53) gene mutation/deletion based on local test.
• Subjects with previously untreated de novo AML or secondary AML with TP53 gene mutation or deletion and who are unlikely to benefit from standard intensive induction therapy or refuse intensive induction therapy at time of enrollment are eligible. All subjects must have documentation of at least one TP53 gene mutation/deletion based on local test. Subjects with secondary AML after MDS must not have received prior chemotherapy or no more than 2 cycles of prior hypomethylating agent for MDS.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0, 1, or 2
• Laboratory values must meet the criteria outlined in the protocol.
• Willing to provide consent for bone marrow aspirate samples for exploratory research at baseline and on-treatment per schedule described in the Schedule of Assessments.
• For subjects with relapsed/refractory disease, recovery from prior anti-cancer treatments including surgery, radiotherapy, chemotherapy or any other anti-cancer therapy to baseline or ≤ Grade 1.
• Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test within 72 hours of the first dose of study treatment.
• Male subjects with female partners of childbearing potential must have azoospermia from a prior vasectomy or underlying medical condition or agree to use an acceptable method of contraception during treatment and for 30 days (which exceeds 5 half-lives) or for the duration required by local regulatory guidance, whichever is longer, after last dose of study treatment.
Exclusion Criteria:
• Subject with relapsed or refractory disease has received treatment for AML or MDS with any of the following:
• Chimeric antigen receptor (CAR)-T cell therapy
• Prior treatment with anti-cluster of differentiation 47 (CD47) targeting agent or cluster of differentiation 40 (CD40) agonist within 28 days prior to
• the first dose of study treatment.
• Prior treatment with signal-regulatory protein alpha (SIRPα)-targeting antibody
• Other experimental therapies for AML or MDS within 14 days or at least 5 half- lives (whichever is shorter) prior to the first dose of study treatment
• Evidence of active central nervous system (CNS) involvement with leukemia
• Subjects requiring agents other than hydroxyurea to control blast counts within 14 days prior to the first dose of study treatment.
• Evidence of active bleeding or bleeding diathesis or major coagulopathy (including familial)
• [Only for Cohorts including Venetoclax in the regimen] Subject has received strong and/or moderate cytochrome P450, family 3, subfamily A (CYP3A) inducers within 7 days prior to the first dose of study treatment.
• Use of corticosteroids or other immunosuppressive medication, current or within 14 days of the first dose of study treatment
• Receipt of live attenuated vaccine within 30 days of first dose of SL-172154 treatment, the exception is that vaccines for coronavirus disease 19 (COVID-19) are permitted.
• Subject has active, uncontrolled infection (e.g, viral, bacterial, or fungal). Subjects are eligible if infection is controlled with antibiotics, antivirals and/or antifungals.
• [Only for Cohorts including Venetoclax in the regimen] Subject has a malabsorption syndrome or other condition that precludes enteral route of administration.
• Symptomatic peptic ulcer disease or gastritis, active diverticulitis, other serious gastrointestinal disease associated with diarrhea within 6 months of first dose of study treatment.
• Clinically significant or uncontrolled cardiac disease including any of the following:
• Myocarditis
• Unstable angina within 6 months from D1 of study treatment
• Acute myocardial infarction within 6 months from D1 of study treatment
• Uncontrolled hypertension
• New York Heart Association (NYHA) Class III or IV congestive heart failure
• Clinically significant (symptomatic) cardiac arrhythmias (e.g., sustained ventricular tachycardia, second- or third- degree atrioventricular (AV) block without a pacemaker, circulatory collapse requiring vasopressor or inotropic support, or arrhythmia not stabilized on therapy)
• Subject has chronic respiratory disease that requires continuous oxygen, or significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or any other medical condition that in the opinion of the investigator would adversely affect his/her participation in the study.
• Subjects who have had any major surgical procedure within 14 days of first dose of study treatment.
• Subject is a woman who is pregnant or breast feeding or planning to become pregnant or breast feed while enrolled in this study.
• Psychiatric illness/social circumstances that would limit compliance with study requirements and substantially increase the risk of adverse events (AEs) or compromised ability to provide written informed consent.
• Presence of another malignancy that requires active therapy and that in the opinion of the investigator and Sponsor would interfere with the monitoring of disease assessments in this study.
• Known hypersensitivity to any of the study medications including excipients of Azacitidine.
• Has undergone solid organ transplantation.
• Known or active human immunodeficiency virus (HIV) infection
• Known or active infection with hepatitis B (positive for hepatitis B surface antigen [HBsAg]) or hepatitis C virus ([HCV]; if hepatitis C virus (HCV) antibody (Ab) test is positive check for HCV ribonucleic acid [RNA]).
Drug: SL-172154
Acute Myeloid Leukemia, Myelodysplastic Syndromes
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Study Locations
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| Location | Contacts |
|---|---|
| Baylor Scott & White Research Institute Fort Worth, Texas | Meiyan Jiang, RN - (Meiyan.Jiang@BSWHealth.org) MD - (Jana.Reynolds@usoncology.com) |
| City of Hope Duarte, California | Manjoyt Nanhwan, SC |
| Dana-Farber Cancer Institute Boston, Massachusetts | Taylor Robertson - (TaylorA_Robertson@DFCI.HARVARD.EDU) |
| Gabrail Cancer Center Canton, Ohio | |
| MD Anderson Cancer Center Houston, Texas | Yamilet Saker, RN - (YSaker1@mdanderson.org) |
| Moffitt Cancer Center Tampa, Florida | Chelsea Conner, CCRP - (chelsea.conner@moffitt.org) |
| Norton Cancer Institute Louisville, Kentucky | Sandy M Stencavage, RN - (Sandy.Stencavage@nortonhealthcare.org) M |
| Princess Margaret Cancer Centre Toronto, Ontario | Erik Adapon, RN - (Erik.Adapon@uhn.ca) - (Brenna.Mahony@uhn.ca) |
| Roswell Park Comprehensive Cancer Center Buffalo, New York | Danielle Wittek, BA - (Danielle.Wittek@RoswellPark.org) |
| START Midwest Grand Rapids, Michigan | Jade Blakeman, RN - (jade.blakeman@startmidwest.com) |
| UCLA Medical Center-Bowyer Oncology Center Los Angeles, California | Bruck Habtemariam - (bhabtemariam@mednet.ucla.edu) |
| UPMC Hillman Cancer Center Pittsburgh, Pennsylvania | Amy Rodgers - (rodgersa@upmc.edu) |
| University of Cincinnati Medical Center Cincinnati, Ohio | Emily Greve, MS - (greveei@ucmail.uc.edu) |
| University of Michigan Ann Arbor, Michigan | Roxana Taralunga - (roxanat@med.umich.edu) |
| University of North Carolina, Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Kiya Birku - (kbirku@email.unc.edu) |
| VCU Massey Cancer Center Richmond, Virginia | Caryn Weir, RN - (cweir@vcu.edu) |
| Yale Cancer Center New Haven, Connecticut | Anne Caldwell, RN - (anne.caldwell@yale.edu) |
Selinexor With Combination With Induction/Consolidation Therapy in Acute Myeloid Leukemia Patients
Study Coordinator - dfunes@wakehealth.edu
NCT02835222
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Inclusion Criteria:
* Patients must have histologically or cytologically documented newly diagnosed de novo Acute Myeloid Leukemia (non-APL) that has not yet been treated. Hydrea,cytarabine and ATRA previous treatments are acceptable.
* Patients with core binding factor acute myeloid leukemia (AML) (ie AML with t(8;21) or t(16;16) or i16) are not eligible.
* Patients must not have a secondary AML (defined as a history of prior radiation therapy or systemic chemotherapy, CMML or MDS not treated with a hypomethylating agent) however history of previous MDS treated with a hypomethylating agent IS allowed.
* Patients with de novo AML must not have partial or total monosomy 5 or 7 or i(17q) or t(17p). Negative FISH studies are sufficient for enrollment (i.e. FISH for -5, -7, +8, inv(16), t(8;21) and 17p).
* Patients must not have mutated FLT3 (either ITD OR TKD mutations).
* Hydroxyurea, leukapheresis or cytarabine may be used to control leukocytosis, provided that it is without Grade \>2 non-hematologic toxicity, and can be taken until start of therapy.
* Age \>18 years.
* ECOG performance status of ≤ 2 and fit for induction therapy in the opinion of the treating physician.
* Laboratory values ≤2 weeks must be:
* AST(SGOT)/ALT(SGPT)≤ 2.5 X institutional upper limit of normal
* Bilirubin ≤ 2 X ULN (3X if known history of Gilbert'syndrome)
* Creatinine clearance (CrCl) must be \> 20 mL/min
* Baseline left ventricular ejection fraction of at least 40% by MUGA or ECHO.
* Female patients of childbearing potential must agree to use 2 methods of contraception (including 1 highly effective and 1 effective method of contraception) and have a negative serum pregnancy test at Screening. Male patients must use an effective barrier method of contraception if sexually active with a female of childbearing potential. For both male and female patients, effective methods of contraception must be used throughout the study and for 3 months following the last dose of study treatment.
* Ability to understand and the willingness to sign an IRB-approved informed consent document.
Exclusion Criteria:
* Patients who have received any therapy other than hydroxyurea, cytarabine or ATRA with the purpose of treating their AML or patients with core binding factor AML or Acute Promyelocytic Leukemia are not eligible.
* Patients with a secondary AML (defined as a history of prior radiation therapy or systemic chemotherapy, CMML or MDS not treated with a hypomethylating agent) however history of previous MDS treated with a hypomethylating agent IS allowed.
* Patients having received prior radiotherapy, treatment with cytotoxic agents, treatment with biologic agents or any anti-cancer therapy for a non-AML malignancy within the 4 weeks prior to treatment with selinexor, or those who have not fully recovered from the acute, non-hematological, non-infectious toxicities of any prior treatment with cytotoxic drugs, radiotherapy or other anti-cancer modalities (returned to baseline status as noted before most recent treatment).
* Patients with another active malignancy that requires treatment excluding non-melanoma skin cancers.
* Patients that have received a chemotherapy regimen with stem cell support in the previous 6 months.
* Patients with known central nervous system involvement should be excluded from this clinical trial because the penetration of selinexor into the CNS is not currently known.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to selinexor.
* Uncontrolled concurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
* Psychiatric illness/social situations that would limit compliance with study requirements.
* Patients with known HIV infection or hepatitis (Note: Patients with known HIV infection are excluded because patients with an immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy.
* Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued.
* Patients unable to swallow tablets, patients with malabsorption syndrome, or any other GI disease or GI dysfunction that could interfere with absorption of study treatment
* Prior exposure to a SINE compound DRUG: Cytarabine, DRUG: Daunorubicin Hydrochloride, DRUG: Selinexor
Untreated Adult Acute Myeloid Leukemia
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Study Locations
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| Location | Contacts |
|---|---|
| Comprehensive Cancer Center of Wake Forest University Winston-Salem, North Carolina | Study Coordinator - (dfunes@wakehealth.edu) |
| Virginia Commonwealth University Massey Cancer Center Richmond, Virginia |
A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011)
Toll Free Number - Trialsites@msd.com
NCT06136559
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* Confirmed diagnosis of CLL/SLL and active disease clearly documented to have a need to initiate therapy.
* Has at least 1 marker of disease burden.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days before randomization.
* Has the ability to swallow and retain oral medication.
* 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 deoxyribonucleic acid (DNA) viral load before randomization.
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV ribonucleic acid (RNA) viral load is undetectable at screening.
* Participants with human immunodeficiency virus (HIV) who meet ALL eligibility criteria.
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* Has an active hepatitis B virus/ hepatitis C virus (HBV/HCV) infection.
* Has gastrointestinal (GI) dysfunction that may affect drug absorption.
* Has diagnosis of Richter Transformation or active central nervous system (CNS) involvement by CLL/SLL.
* Has had acquired immune deficiency syndrome (AIDS)-defining opportunistic infection in the past 12 months before screening.
* Has clinically significant cardiovascular disease.
* Has hypersensitivity to nemtabrutinib or contraindication to ibrutinib or acalabrutinib, or any of the excipients.
* Has history of severe bleeding disorder.
* Has known additional malignancy that is progressing or has required active treatment within the past 2 years.
* Has received any systemic anticancer therapy for CLL/SLL.
* Is currently being treated with p-glycoprotein (P-gp) substrates with a narrow therapeutic index, cytochrome P450 3A (CYP3A) strong or moderate inducers or CYP3A strong inhibitors.
* 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. Administration of killed vaccines are allowed.
* Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration.
* Has active infection requiring systemic therapy, including intravenous (IV) antibiotics during screening.
* Participants who have not adequately recovered from major surgery or have ongoing surgical complications. DRUG: Nemtabrutinib, DRUG: Ibrutinib, DRUG: Acalabrutinib
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
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Show 193 locations
Study Locations
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| Location | Contacts |
|---|---|
| AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0205) Mechelen, Antwerpen | |
| Aalborg Universitetshospital, Syd ( Site 0403) Aalborg, North Denmark | |
| Akershus Universitetssykehus ( Site 0902) Lørenskog, Akershus | |
| Alta Bates Summit Medical Center ( Site 0004) Berkeley, California | |
| Anhui Provincial Cancer Hospital ( Site 2001) Hefei, Anhui | |
| Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1407) Ankara, | |
| Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 1401) Ankara, | |
| Antalya Egitim ve Arastırma Hastanesi ( Site 1409) Antalya, | |
| Aotearoa Clinical Trials ( Site 3201) Auckland, | |
| Arizona Oncology Associates - NAHOA ( Site 8007) Prescott, Arizona | |
| BC Cancer Kelowna ( Site 0112) Kelowna, British Columbia | |
| BC Cancer Victoria ( Site 0109) Victoria, British Columbia | |
| Barnet Hospital ( Site 3005) Barnet, | |
| Bnai Zion Medical Center ( Site 1505) Haifa, | |
| Bradfordhill-Clinical Area ( Site 2310) Santiago, Region M. de Santiago | |
| Cancer Care Associates Of York ( Site 0005) York, Pennsylvania | |
| Cancer Institute Hospital of JFCR ( Site 1906) Koto, Tokyo | |
| Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski ( Site 0100) Rimouski, Quebec | |
| Centro Medico Monte Carmelo-Oncology ( Site 2706) Arequipa, Ariqipa | |
| Centro de Infusion Superare ( Site 2602) Mexico City, Mexico City | |
| Champalimaud Foundation ( Site 3102) Lisbon, Lisbon District | |
| Chang Gung Medical Foundation-Linkou Branch ( Site 1703) Taoyuan District, | |
| Chang Gung Memorial Hospital at Kaohsiung-Division of Hematology and Oncology ( Site 1702) Kaohsiung City, | |
| Chiba Cancer Center ( Site 1905) Chiba, | |
| Chongqing University Cancer Hospital ( Site 2041) Chongqing, Chongqing Municipality | |
| Chulalongkorn University ( Site 1802) Bangkok, Bangkok | |
| City Hospital, Nottingham University Hospitals NHS Trust ( Site 3003) Nottingham, | |
| Clermont Oncology Center ( Site 0046) Clermont, Florida | |
| Clínica Alemana de Santiago-Unidad de Investigaciones ( Site 2306) Santiago, Region M. de Santiago | |
| Clínica Anglo Americana ( Site 2701) Lima, | |
| Constantiaberg Haematology ( Site 1106) Plumstead, Western Cape | |
| Consultants in Medical Oncology and Hematology (CMOH) ( Site 8002) Broomall, Pennsylvania | |
| Corewell Health-Lemmon Holton Cancer Pavilion ( Site 0011) Grand Rapids, Michigan | |
| Eastern CT Hematology & Oncology Associates ( Site 0033) Norwich, Connecticut | |
| Ege Universitesi Hastanesi ( Site 1404) Izmir, | |
| Evangelismos General Hospital of Athens ( Site 0700) Athens, Attica | |
| FALP-UIDO ( Site 2300) Santiago, Region M. de Santiago | |
| Faculty of Medicine Siriraj Hospital-Division of Hematology, Department of Medicine ( Site 1801) Bangkok, Bangkok | |
| Fakultni nemocnice Hradec Kralove-IV. interni hematologicka klinika ( Site 0301) Hradec Králové, | |
| Fakultni nemocnice Olomouc ( Site 0303) Olomouc, | |
| Florida Cancer Specialists - East ( Site 7002) West Palm Beach, Florida | |
| Florida Cancer Specialists - South ( Site 7001) Fort Myers, Florida | |
| Fundacion Valle del Lili- CIC-Oncology CIC ( Site 2402) Cali, Valle del Cauca Department | |
| Galilee Medical Center ( Site 1507) Nahariya, | |
| General Hospital of Athens "Laiko" ( Site 0704) Athens, Attica | |
| GenesisCare - Bristol ( Site 3011) Bristol, South Gloucestershire | |
| GenesisCare - Cambridge ( Site 3001) Newmarket, Suffolk | |
| GenesisCare - Windsor ( Site 3002) Windsor, Windsor And Maidenhead | |
| Groote Schuur Hospital-Clinical Haematology ( Site 1100) Cape Town, Western Cape | |
| Grupo Médico ASSET ( Site 2611) Mexico City, | |
| Guangxi Medical University Affiliated Tumor Hospital ( Site 2004) Nanning, Guangxi | |
| Gunma University Hospital ( Site 1903) Maebashi, Gunma | |
| HOSPITAL CLÍNIC DE BARCELONA ( Site 1202) Barcelona, Catalonia | |
| HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 1208) Majadahonda, Madrid, Comunidad de | |
| HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1209) Pozuelo de Alarcón, Madrid | |
| Hadassah Medical Center-Hemato-Oncology ( Site 1500) Jerusalem, | |
| Haemalife ( Site 1105) Kuilsriver, Western Cape | |
| Hainan General Hospital ( Site 2018) Haikou, Hainan | |
| Health Pharma Professional Research S.A. de C.V: ( Site 2608) Mexico City, Mexico City | |
| Henan Cancer Hospital-hematology department ( Site 2025) Zhengzhou, Henan | |
| Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital ( Site 1913) Hiroshima, | |
| Hokkaido University Hospital ( Site 1900) Sapporo, Hokkaido | |
| Hospital 9 De Julho ( Site 2206) São Paulo, São Paulo | |
| Hospital Paulistano-Americas Oncologia ( Site 2202) São Paulo, | |
| Hospital Pulau Pinang ( Site 1602) George Town, Pulau Pinang | |
| Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1206) Barcelona, | |
| Hospital Universitario de Salamanca - Complejo Asistencial U-Servicio de Hematologia ( Site 1201) Salamanca, | |
| Hunan Cancer Hospital ( Site 2020) Changsha, Hunan | |
| IMAT S.A.S ( Site 2401) Montería, Departamento de Córdoba | |
| InVO Institut für Versorgungsforschung in der Onkologie ( Site 0606) Koblenz, Rhineland-Palatinate | |
| Inova Schar Cancer Institute ( Site 0015) Fairfax, Virginia | |
| Institut Català d'Oncologia - L'Hospitalet-Haematology Department ( Site 1207) L'Hospitalet Del Llobregat, Barcelona | |
| Institute of hematology&blood disease hospital-Lymphoma ( Site 2005) Tianjin, Tianjin Municipality | |
| Instituto Nacional de Câncer - INCA ( Site 2201) Rio de Janeiro, | |
| Instituto Português de Oncologia de Lisboa Francisco Gentil ( Site 3103) Lisbon, Lisbon District | |
| Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 3100) Porto, | |
| Intermountain Health St. Mary's Regional Hospital ( Site 0025) Grand Junction, Colorado | |
| Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0052) Billings, Montana | |
| Japanese Red Cross Osaka Hospital ( Site 1908) Osaka, | |
| Jiangsu Province Hospital ( Site 2000) Nanjing, Jiangsu | |
| Jiangxi Provincial Cancer Hospital ( Site 2009) Nanchang, Jiangxi | |
| John Theurer Cancer Center at Hackensack University Medical Center ( Site 0016) Hackensack, New Jersey | |
| Karolinska Universitetssjukhuset Solna ( Site 1302) Stockholm, Stockholm County | |
| Kindai University Hospital ( Site 1909) Sakai, Osaka | |
| Kliniken Maria Hilf ( Site 0603) Mönchengladbach, North Rhine-Westphalia | |
| Kobe City Medical Center General Hospital ( Site 1910) Kobe, Hyōgo | |
| Kyushu University Hospital ( Site 1914) Fukuoka, | |
| Liuzhou People's Hospital ( Site 2029) Liuchow, Guangxi | |
| Lutheran Medical Center ( Site 0027) Golden, Colorado | |
| Maharaj Nakorn Chiang Mai Hospital ( Site 1800) Muang, Chiang Mai | |
| Marmara Universitesi Pendik Egitim Arastirma Hastanesi ( Site 1408) Istanbul, | |
| McGill University Health Centre ( Site 0106) Montreal, Quebec | |
| Medical Oncology Associates, PS (dba Summit Cancer Centers) ( Site 0010) Spokane, Washington | |
| Mega Medipol ( Site 1412) Istanbul, | |
| MidAmerica Cancer Care, LLC ( Site 0043) Kansas City, Missouri | |
| Moores Cancer Center ( Site 0003) La Jolla, California | |
| Nagoya University Hospital ( Site 1907) Nagoya, Aichi-ken | |
| Naresuan University Hospital ( Site 1804) Muang, Changwat Phitsanulok | |
| Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1000) Gliwice, Silesian Voivodeship | |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site 1004) Warsaw, Masovian Voivodeship | |
| National Cheng Kung University Hospital ( Site 1700) Tainan, | |
| National Taiwan University Hospital ( Site 1701) Taipei, | |
| Netcare Pretoria East Hospital-Alberts Cellular Therapy ( Site 1101) Pretoria, Gauteng | |
| North Shore Hospital-Department of Haematology ( Site 3200) Auckland, | |
| Odense Universitetshospital-Department of Hematology ( Site 0401) Odense C, Region Syddanmark | |
| Okayama University Hospital ( Site 1912) Okayama, | |
| Oncology Specialists of Charlotte ( Site 0054) Charlotte, North Carolina | |
| Ondokuz Mays Üniversitesi ( Site 1410) Samsun, | |
| Onkologische Schwerpunktpraxis Kurfuerstendamm ( Site 0600) Berlin, | |
| Oslo Universitetssykehus Rikshospitalet-Avdeling for blodsykdommer ( Site 0901) Oslo, | |
| Parkview Research Center at Parkview Regional Medical Center ( Site 0002) Fort Wayne, Indiana | |
| Peking University First Hospital ( Site 2022) Beijing, Beijing Municipality | |
| Peking University Third Hospital-Hematology ( Site 2011) Beijing, Beijing Municipality | |
| Pratia MCM Krakow ( Site 1007) Krakow, Lesser Poland Voivodeship | |
| Pratia Onkologia Katowice ( Site 1009) Katowice, Silesian Voivodeship | |
| Queen Elizabeth Hospital ( Site 1603) Kota Kinabalu, Sabah | |
| Queen Mary Hospital ( Site 3300) Hong Kong, | |
| Rabin Medical Center ( Site 1504) Petah Tikva, | |
| Rambam Health Care Campus-Hematology and Bone Marrow Transplantation ( Site 1503) Haifa, | |
| Regions Hospital ( Site 0042) Saint Louis Park, Minnesota | |
| Roskilde Sygehus-Department of Hematology ( Site 0402) Roskilde, Region Sjælland | |
| Roswell Park Cancer Institute ( Site 0023) Buffalo, New York | |
| Royal Lancaster Infirmary ( Site 3012) Lancaster, Lancashire | |
| Royal North Shore Hospital ( Site 2806) St Leonards, New South Wales | |
| SSM Health Dean Medical Group - South Madison Campus Health Research/Circuit Clinical ( Site 0048) Madison, Wisconsin | |
| Saint Elizabeth Healthcare ( Site 0041) Edgewood, Kentucky | |
| Saint Joseph Hospital ( Site 0026) Denver, Colorado | |
| Samodzielny Publiczny Zakład Opieki Zdrowotnej MSWiA w Olsztynie-Oddzial Kliniczny Hematologii ( Site 1005) Olsztyn, Warmian-Masurian Voivodeship | |
| Shaanxi provincial people's hospital ( Site 2012) Xi'an, Shaanxi | |
| Shandong Cancer Hospital ( Site 2003) Jinan, Shandong | |
| Shanxi Cancer Hospital ( Site 2033) Taiyuan, Shanxi | |
| Sheba Medical Center-Hemato Oncology ( Site 1501) Ramat Gan, | |
| Shimane University Hospital ( Site 1911) Izumo, Shimane | |
| Sisli Florence Nightingale Hastanesi ( Site 1411) Istanbul, | |
| Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 2405) Valledupar, Cesar Department | |
| Songklanagarind hospital ( Site 1803) Hat Yai, Changwat Songkhla | |
| Southeastern Medical Oncology Center ( Site 0049) Goldsboro, North Carolina | |
| Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 2006) Guangzhou, Guangdong | |
| Southmead Hospital ( Site 3010) Bristol, Bristol, City of | |
| St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3006) London, London, City of | |
| St James's University Hospital ( Site 3004) Leeds, | |
| Summit Medical Group Cancer Center ( Site 0007) Florham Park, New Jersey | |
| Sun Yat-sen University Cancer Center ( Site 2028) Guangzhou, Guangdong | |
| Sykehuset i Vestfold ( Site 0903) Tønsberg, Vestfold | |
| TENNESSEE ONCOLOGY ( Site 0031) Nashville, Tennessee | |
| Tennessee Oncology-Chattanooga ( Site 0045) Chattanooga, Tennessee | |
| Texas Oncology - Central/South Texas ( Site 8008) Austin, Texas | |
| Texas Oncology - Northeast Texas ( Site 8012) Tyler, Texas | |
| Texas Oncology - San Antonio ( Site 8006) San Antonio, Texas | |
| The Affiliated Hospital of Guizhou Medical University ( Site 2024) Guiyang, Guizhou | |
| The Affiliated Hospital of Xuzhou Medical College ( Site 2013) Xuzhou, Jiangsu | |
| The Center for Cancer and Blood Disorders ( Site 0032) Fort Worth, Texas | |
| The Churchill Hospital ( Site 3007) Oxford, Oxfordshire | |
| The First Affiliated Hospital of Nanchang University ( Site 2023) Nanchang, Jiangxi | |
| The First Affliated Hospital of Suzhou University ( Site 2027) Suzhou, Jiangsu | |
| The First Hospital of Jilin University-Hematology ( Site 2030) Changchun, Jilin | |
| The Ottawa Hospital - General Campus ( Site 0102) Ottawa, Ontario | |
| The Second Xiangya Hospital of Central South University ( Site 2010) Changsha, Hunan | |
| The first Affiliated Hospital, Zhejiang University School of Medicine-Hematology ( Site 2002) Hangzhou, Zhejiang | |
| Tianjin Medical University Cancer Institute & Hospital-lymphoma ( Site 2019) Tianjin, Tianjin Municipality | |
| Tohoku University Hospital ( Site 1901) Sendai, Miyagi | |
| Tongji Hospital Affiliated to Tongji Medical College of HUST ( Site 2016) Wuhan, Hubei | |
| Trakya University-Balkan Onkoloji Hastanesi ( Site 1403) Edirne, | |
| USA Mitchell Cancer Institute ( Site 0014) Mobile, Alabama | |
| UZ Leuven-Hematology ( Site 0200) Leuven, Vlaams-Brabant | |
| Unidade Local de Saude Gaia/Espinho - Hospital Eduardo Santos Silva ( Site 3107) Vila Nova de Gaia, Porto District | |
| Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 3104) Lisbon, | |
| Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 3106) Lisbon, | |
| Universitaetsklinikum Ulm. ( Site 0601) Ulm, Baden-Wurttemberg | |
| University Hospital and UW Health Clinics ( Site 0006) Madison, Wisconsin | |
| University Hospital of Alexandroupolis ( Site 0701) Alexandroupoli, East Macedonia and Thrace | |
| University Hospital of Ioannina ( Site 0702) Ioannina, | |
| University Malaya Medical Centre ( Site 1604) Lembah Pantai, Kuala Lumpur | |
| University of Iowa Health Care. ( Site 0017) Waukee, Iowa | |
| University of Iowa Health Care. ( Site 0057) Waukee, Iowa | |
| University of Virginia Cancer Center ( Site 0040) Charlottesville, Virginia | |
| Universitätsklinikum Halle ( Site 0604) Halle, Saxony-Anhalt | |
| Uniwersytecki Szpital Kliniczny nr 1 w Lublinie-Oddział Hematoonkologii-Transplantacji Szpiku i Chem ( Site 1006) Lublin, Lublin Voivodeship | |
| Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 1011) Gdansk, Pomeranian Voivodeship | |
| VK&K Studien GbR ( Site 0607) Landshut, Bavaria | |
| Virginia Commonwealth University (VCU) Medical Center ( Site 0030) Richmond, Virginia | |
| Vseobecna fakultni nemocnice v Praze-I. Interní klinika - klinika hematologie ( Site 0302) Prague, | |
| Waikato Hospital-Haematology ( Site 3202) Hamilton, Waikato Region | |
| West China Hospital, Sichuan University-Head and Neck Oncology ( Site 2026) Chengdu, Sichuan | |
| William Osler Health System ( Site 0103) Brampton, Ontario | |
| Wits Clinical Research ( Site 1102) Johannesburg, Gauteng | |
| Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku-Oddział Hematologii i Transplantacji ( Site 1013) Słupsk, Pomeranian Voivodeship | |
| Wuhan Union Hospital ( Site 2015) Wuhan, Hebei | |
| Xinjiang Medical University Cancer Hospital - Urumqi ( Site 2014) Ürümqi, Xinjiang | |
| Yamagata University Hospital ( Site 1902) Yamagata, | |
| Yitzhak Shamir Medical Center. ( Site 1506) Ẕerifin, | |
| Zhejiang Cancer Hospital ( Site 2017) Hangzhou, Zhejiang | |
| hospital universitario de canarias ( Site 1205) San Cristóbal de La Laguna, Santa Cruz De Tenerife |
Long-Term Follow-Up of Patients Who Have Participated in Children's Oncology Group Studies
Gwaltney, Lindsey - lbgwaltney@vcu.edu
Gowda, Madhu, S
NCT00736749
HM12659
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Inclusion Criteria:
* The patient must reside in the U.S. on the date of enrollment to ALTE05N1
* 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: Assessment of Therapy Complications, OTHER: Questionnaire Administration
Hematopoietic Cell Transplantation Recipient, Leukemia, Solid Tumor
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Show 164 locations
Study Locations
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| Location | Contacts |
|---|---|
| Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Albany Medical Center Albany, New York | |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (dperry@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 | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Arnold Palmer Hospital for Children Orlando, Florida | Site Public Contact - (melissa.leffin@orlandohealth.com) |
| Ascension Saint John Hospital Detroit, Michigan | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | Site Public Contact - (helpdesk@childrensoncologygroup.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 - (helpdesk@childrensoncologygroup.org) |
| Broward Health Medical Center Fort Lauderdale, Florida | |
| C S Mott Children's Hospital Ann Arbor, Michigan | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Cedars Sinai Medical Center Los Angeles, California | |
| Children's Healthcare of Atlanta - Egleston Atlanta, Georgia | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital Colorado Aurora, Colorado | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital Los Angeles Los Angeles, California | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital Medical Center Of Akron Akron, Ohio | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital New Orleans New Orleans, Louisiana | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Alabama Birmingham, Alabama | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Orange County Orange, California | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of San Antonio San Antonio, Texas | Site Public Contact - (helpdesk@childrensoncologygroup.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 - (helpdesk@childrensoncologygroup.org) |
| Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Mercy Hospitals and Clinics Kansas City, Missouri | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's National Medical Center Washington D.C., District of Columbia | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| City of Hope Comprehensive Cancer Center Duarte, California | Site Public Contact - (becomingapatient@coh.org) |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (CancerAnswer@ccf.org) |
| Columbia Regional Columbia, Missouri | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Connecticut Children's Medical Center Hartford, Connecticut | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Cook Children's Medical Center Fort Worth, Texas | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Dartmouth Hitchcock Medical Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Dayton Children's Hospital Dayton, Ohio | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Dell Children's Medical Center of Central Texas Austin, Texas | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Driscoll Children's Hospital Corpus Christi, Texas | Site Public Contact - (helpdesk@childrensoncologygroup.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 | |
| Floating Hospital for Children at Tufts Medical Center Boston, Massachusetts | |
| Florida Hospital Orlando Orlando, Florida | Site Public Contact - (FH.Cancer.Research@flhosp.org) |
| Golisano Children's Hospital of Southwest Florida Fort Myers, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Greenville Cancer Treatment Center Greenville, South Carolina | |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Helen DeVos Children's Hospital at Spectrum Health Grand Rapids, Michigan | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Inova Fairfax Hospital Falls Church, Virginia | |
| Johns Hopkins All Children's Hospital St. Petersburg, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| 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 | |
| Lee Memorial Health System Fort Myers, Florida | |
| Legacy Emanuel Children's Hospital Portland, Oregon | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania | |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | |
| Loma Linda University Medical Center Loma Linda, California | |
| Loyola University Medical Center Maywood, Illinois | |
| Lucile Packard Children's Hospital Stanford University Palo Alto, California | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Lurie Children's Hospital-Chicago Chicago, Illinois | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Madigan Army Medical Center Tacoma, Washington | Site Public Contact - (mamcdci@amedd.army.mil) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Mary Bridge Children's Hospital and Health Center Tacoma, Washington | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Mattel Children's Hospital UCLA Los Angeles, California | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Mayo Clinic Jacksonville, Florida | |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| Medical City Dallas Hospital Dallas, Texas | |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Mercy Children's Hospital Toledo, Ohio | |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Methodist Children's Hospital of South Texas San Antonio, Texas | |
| Miami Cancer Institute Miami, Florida | Site Public Contact - (cancerinfo@baptisthealth.net) |
| Miller Children's and Women's Hospital Long Beach Long Beach, California | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Mission Hospital Inc-Memorial Campus Asheville, North Carolina | Site Public Contact - (leslie.verner@msj.org) |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (aaraiza@montefiore.org) |
| Morristown Medical Center Morristown, New Jersey | |
| Mount Sinai Hospital New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York | Site Public Contact - (nr2616@cumc.columbia.edu) |
| NYU Winthrop Hospital Mineola, New York | |
| Natalie Warren Bryant Cancer Center at Saint Francis Tulsa, Oklahoma | |
| Nationwide Children's Hospital Columbus, Ohio | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Naval Medical Center - Portsmouth Portsmouth, Virginia | |
| Nemours Children's Clinic - Orlando Orlando, Florida | |
| Nemours Children's Clinic - Pensacola Pensacola, Florida | |
| Nemours Children's Clinic-Jacksonville Jacksonville, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Nemours Children's Hospital Orlando, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| New York Medical College Valhalla, New York | |
| Newark Beth Israel Medical Center Newark, New Jersey | |
| Norton Children's Hospital Louisville, Kentucky | |
| Novant Health Presbyterian Medical Center Charlotte, North Carolina | Site Public Contact - (nnechiporchik@novanthealth.org) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Gregory.Johnstone@ochsner.org) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Overlook Hospital Summit, New Jersey | |
| Penn State Children's Hospital Hershey, Pennsylvania | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Phoenix Childrens Hospital Phoenix, Arizona | |
| Primary Children's Hospital Salt Lake City, Utah | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Prisma Health Richland Hospital Columbia, South Carolina | |
| Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Rady Children's Hospital - San Diego San Diego, California | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Rainbow Babies and Childrens Hospital Cleveland, Ohio | |
| Rhode Island Hospital Providence, Rhode Island | |
| Riley Hospital for Children Indianapolis, Indiana | |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey | |
| Saint Christopher's Hospital for Children Philadelphia, Pennsylvania | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida | |
| Saint Joseph's Regional Medical Center Paterson, New Jersey | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Saint Jude Midwest Affiliate Peoria, Illinois | |
| Saint Luke's Mountain States Tumor Institute Boise, Idaho | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Saint Mary's Hospital Rhinelander, Wisconsin | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Saint Peter's University Hospital New Brunswick, New Jersey | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (Christy.Gilchrist@hshs.org) |
| Saint Vincent Hospital and Health Care Center Indianapolis, Indiana | Site Public Contact - (research@stvincent.org) |
| San Jorge Children's Hospital San Juan, | |
| 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 | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Sinai Hospital of Baltimore Baltimore, Maryland | Site Public Contact - (pridgely@lifebridgehealth.org) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| St. Jude Children's Research Hospital Memphis, Tennessee | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| 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) |
| Sunrise Hospital and Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| T C Thompson Children's Hospital Chattanooga, Tennessee | |
| The Toledo Hospital/Toledo Children's Hospital Toledo, Ohio | |
| The University of Arizona Medical Center-University Campus Tucson, Arizona | |
| Tulane University Health Sciences Center New Orleans, Louisiana | |
| UCSF Medical Center-Mission Bay San Francisco, California | |
| UCSF Medical Center-Parnassus San Francisco, California | |
| UF Cancer Center at Orlando Health Orlando, Florida | |
| 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 Medical Center of Southern Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| University of Alabama at Birmingham Cancer Center Birmingham, Alabama | |
| University of Arkansas for Medical Sciences Little Rock, Arkansas | |
| 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 | |
| University of Hawaii Cancer Center Honolulu, Hawaii | |
| University of Illinois Chicago, Illinois | |
| 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 | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (LByatt@nmcca.org) |
| 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 Vermont and State Agricultural College Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| University of Wisconsin Hospital and Clinics Madison, Wisconsin | |
| Valley Children's Hospital Madera, California | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Virginia Commonwealth University/Massey Cancer Center Richmond, Virginia | Site Public Contact - (mwellons@vcu.edu) |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Walter Reed National Military Medical Center Bethesda, Maryland | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Wayne State University/Karmanos Cancer Institute Detroit, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| West Virginia University Charleston Division Charleston, West Virginia | |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Reduced IV Fluids to Improve Clearance of HDMTX in Children w/Lymphoma or Acute Lymphoblastic Leukemia
Cady P Noda, Pharm.D. - cady.noda@vcuhealth.org
Noda, Cady, Ploessl
NCT03964259
HM20016430
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Inclusion Criteria:
• Diagnosis of lymphoma or acute lymphoblastic leukemia
• Candidate for a minimum of 2 cycles HDMTX (5 g/m2) in the inpatient setting
• Creatinine clearance ≥ 65 mL/min by modified Schwartz equation
• Patients of childbearing potential must have a negative pregnancy test (serum or urine)
• Lactating female patients must agree not to nurse a child while on this trial
• All patients and/or their parents or legal guardians must provide written informed consent, with assent provided if applicable
Exclusion Criteria:
• Trisomy 21
• History of dialysis within 30 days prior to study registration or currently on dialysis
• Polyuric renal dysfunction
• Pregnancy
• Known or suspected pleural effusion
• Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements
Drug: Intravenous fluids
Lymphoma, Acute Lymphoblastic Leukemia, Pediatric Cancer, Pediatric ALL, Pediatric Lymphoma
High Dose Methotrexate, HDMTX, Intravenous Fluids
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Study Locations
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University/ Massey Cancer Center/ Children's Hospital of Richmond Richmond, Virginia | Lindsey B Gwaltney, RN - (lbgwaltney@vcu.edu) Cady P Noda, Pharm.D. - (cady.noda@vcuhealth.org) |
A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
Elizabeth Fosberg, B.A. - 10-CBA@ndmp.org
McCarty, John, M.
NCT01351545
HM13913
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Inclusion Criteria:
* Disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment
* Signed informed consent (and signed assent, if applicable) obtained prior to study enrollment
* Pediatric and adult patients of any age
Exclusion Criteria:
* Patients who are receiving only licensed CBUs
* Cord blood transplant recipients at international transplant centers
* Patients who are enrolled on another IND protocol to access the unlicensed CBU(s)
* Patients whose selected unlicensed CBU(s) will be more than minimally manipulated DRUG: A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)
Hematologic Malignancies, Inherited Disorders of Metabolism, Inherited Abnormalities of Platelets, Histiocytic Disorders, Acute Myelogenous Leukemia (AML or ANLL), Acute Lymphoblastic Leukemia (ALL), Other Acute Leukemia, Chronic Myelogenous Leukemia (CML), Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases, Other Leukemia, Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Multiple Myeloma/ Plasma Cell Disorder (PCD), Inherited Abnormalities of Erythrocyte Differentiation or Function, Disorders of the Immune System, Autoimmune Diseases, Severe Aplastic Anemia
I'm interested
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See this study on ClinicalTrials.gov
Show 142 locations
Study Locations
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| Location | Contacts |
|---|---|
| AdventHealth Orlando Orlando, Florida | Rushang Patel, MD - (rushang.patel.md@adventhealth.com) |
| Advocate Lutheran General Hospital Park Ridge, Illinois | |
| All Children's Hospital St. Petersburg, Florida | Deepakbabu Chellapandian, MD - (dchella2@jhmi.edu) |
| Amarillo Blood and Marrow Transplant Program Amarillo, Texas | |
| Ann & Robert H. Lurie Children's Hospital of Chicago Chicago, Illinois | Sonali Chaudhury, MD - (schaudhury@luriechildrens.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | Jason Farrar, MD - (JEFarrar@uams.edu) |
| Avera Transplant Institute Sioux Falls, South Dakota | Waqas Jehangir, MD, FACP - (waqas.jehangir@avera.org) |
| Banner MD Anderson Cancer Center Gilbert, Arizona | Matthew Ulrickson, MD - (Matthew.Ulrickson@bannerhealth.com) |
| Beth Israel Deaconess Boston, Massachusetts | David Avigan, MD - (davigan@bidmc.harvard.edu) |
| Cardinal Glennon Children's Medical Center St Louis, Missouri | Deepika Bhatla, MD - (dbhatla@slu.edu) |
| Children's Healthcare of Atlanta Atlanta, Georgia | Ann Haight, MD - (Ann.haight@choa.org) |
| Children's Hospital Colorado Aurora, Colorado | Michael Verneris, MD - (MICHAEL.VERNERIS@CUANSCHUTZ.EDU) |
| Children's Hospital and Research Center of Oakland Oakland, California | Mark Walters, MD - (mwalters@mail.cho.org) |
| Children's Hospital at Montefiore The Bronx, New York | Mahvish Rahim, MD - (mrahim@montefiore.org) |
| Children's Hospital of Los Angeles Glendale, California | Neena Kapoor, MD - (nkapoor@chla.usc.edu) |
| Children's Hospital of Michigan Detroit, Michigan | Sureyya Savasan, MD - (ssavasan@med.wayne.edu) |
| Children's Hospital of New Orleans/LSUHSC New Orleans, Louisiana | Lolie Yu, MD - (lyu@lsuhsc.edu) |
| Children's Hospital of Orange County (CHOC) Orange, California | Rishikesh Chavan, MD - (rishikesh.chavan@choc.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Timothy Olson, MD - (olsont@email.chop.edu) |
| Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania | Paul Szabolcs, MD - (Paul.szabolcs@chp.edu) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | David Margolis, MD - (dmargoli@mcw.edu) |
| Children's Medical Center Dallas Dallas, Texas | Victor Aquino, MD - (Victor.aquino@utsouthwestern.edu) |
| Children's Mercy Hospital and Clinics Kansas City, Missouri | |
| Children's National Medical Center Washington D.C., District of Columbia | David Jacobsohn, MD - (dajacobs@childrensnational.org) |
| Childrens Hospital Medical Center of Akron Akron, Ohio | Megan Sampson, MD - (msampson@akronchildrens.org) |
| Cincinnati Children's Hospital Cincinnati, Ohio | Stella Davies, MD - (stella.davies@cchmc.org) |
| City of Hope Duarte, California | Monzr Al Malki, MD - (malmalki@coh.org) |
| Cleveland Clinic Cleveland, Ohio | Claudio Brunstein, MD - (brunstc@ccf.org) |
| Cohen Children's Medical Center of New York New Hyde, New York | Jonathan Fish, MD - (jfish1@nshs.edu) |
| Columbia University Medical Center - Morgan Stanley Children's Hospital New York, New York | Monica Bhatia, MD - (mb2476@columbia.edu) |
| Cook Children's Hospital Fort Worth, Texas | Gretchen Eames, MD - (gretchen.eames@cookchildrens.org) |
| Dana Farber Cancer Institute Boston, Massachusetts | Corey Cutler, MD - (cscutler@partners.org) |
| Duke University Medical Center Durham, North Carolina | Joanne Kurtzberg, MD - (kurtz001@mc.duke.edu) |
| Emory University Hospital Atlanta, Georgia | |
| Florida Center for Pediatric Cellular Therapy Orlando, Florida | Susan Kelly, MD - (susan.kelly.md@flhosp.org) |
| Fred Hutchinson Cancer Research Center Seattle, Washington | Ann Dahlberg, MD - (adahlber@fredhutch.org) |
| Georgia Cancer Center at Augusta University Health Augusta, Georgia | Vamsi K Kota, MD - (vkota@augusta.edu) |
| Greenebaum Cancer Center - University of Maryland Baltimore, Maryland | |
| H Lee Moffitt Cancer Center Tampa, Florida | |
| Hackensack University Medical Center Hackensack, New Jersey | Alfred Gillio, MD - (agillio@humed.com) |
| Helen DeVos Children's Hospital Grand Rapids, Michigan | Troy Quigg, MD - (troy.quigg@spectrumhealth.org) |
| Henry Ford Health System Detroit, Michigan | Nalini Janakiraman, MD - (njanaki1@hfhs.org) |
| Indiana Blood & Marrow Transplantation Beech Grove, Indiana | Luke Akard, MD - (lakard@ibmtindy.com) |
| Indiana University/Riley Hospital for Children Indianapolis, Indiana | Jodi Skiles, MD - (jskiles@iupui.edu) |
| Johns Hopkins Baltimore, Maryland | Allen Chen, MD, PhD - (allenchen@jhmi.edu) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | Randal Wada, MD - (randalw@hawaii.edu) |
| Karmanos Cancer Institute Detroit, Michigan | |
| Levine Children's Hospital Charlotte, North Carolina | Jeffrey Huo, MD - (Jeffrey.Huo@carolinashealthcare.org) Michelle Hyland - (Michelle.Hyland@carolinashealthcare.org) |
| Loma Linda University Cancer Center Loma Linda, California | Hisham Abdel-Azim, MD - (habdelazim@llu.edu) |
| Loyola University Medical Center Maywood, Illinois | Patrick Hagen, MD - (patrick.hagen@lumc.edu) |
| M.D. Anderson Cancer Center Houston, Texas | Elizabeth Shpall, MD - (eshpall@mdanderson.org) |
| Massachusetts General Hospital Boston, Massachusetts | |
| Mayo Clinic - Jacksonville Jacksonville, Florida | Vivek Roy, MD - (roy.vivek@mayo.edu) |
| Mayo Clinic Arizona (adults) Phoenix, Arizona | James Slack, MD - (slack.james@mayo.edu) |
| Mayo Clinic Rochester Rochester, Minnesota | |
| Medical City Dallas Dallas, Texas | Vikas Bhushan, MD - (vikas.bhushan@usoncology.com) |
| Medical College of Wisconsin Milwaukee, Wisconsin | Hamadani Mehdi, MD - (mhamadani@mcw.edu) |
| Medical University of South Carolina Charleston, South Carolina | Michelle Hudspeth, MD - (hudspeth@musc.edu) |
| Memorial Sloan-Kettering Cancer Center New York, New York | Ioannis Politikos, MBBS - (politiki@mskcc.org) |
| Methodist Healthcare Blood and Marrow Transplant Center Memphis, Tennessee | |
| Methodist Healthcare System of San Antonio/Texas Transplant Institute San Antonio, Texas | Jose Cruz, MD - (josecarlos.cruz@hcahealthcare.com) |
| Midwestern Regional Medical Center Zion, Illinois | |
| Mount Sinai Medical Center - New York New York, New York | Alla Keyzner, MD - (alla.keyzner@mssm.edu) |
| NIH/NCI Bethesda, Maryland | |
| Nationwide Children's Hospital Columbus, Ohio | Rolla Abu-Arja, MD - (rolla.abu-arja@nationwidechildrens.org) |
| Nemours - Alfred I. duPont Hospital for Children Brandywine, Delaware | Emi Caywood, MD - (ecaywood@nemours.org) |
| Nemours Children's Hospital - Mayo Jacksonville Jacksonville, Florida | Edward Ziga, MD - (Edward.ziga@nemours.org) |
| New York Presbyterian Hospital at Cornell New York, New York | Tsiporah Shore, MD - (tbs2001@med.cornell.edu) |
| New York University Langone Medical Center New York, New York | Mohammad M Abdul Hay, MD - (maher.abdulhay@nyulangone.org) Antoine Mesidor - (Antoine.Mesidor@nyulangone.org) |
| Nih/Nhlbi Bethesda, Maryland | Richard Childs, MD - (childsr@nih.gov) |
| Nih/Niaid Bethesda, Maryland | Elizabeth Kang, MD - (ekang@niaid.nih.gov) |
| Niklaus Children's Hospital Miami, Florida | Jorge Galvez-Silva, MD - (jorgericardo.galvezsilva@nicklaushealth.org) |
| North Shore University Hospital Manhasset, New York | Ruthee L Bayer, MD - (rbayer@nshs.edu) |
| Northside Hospital Atlanta, Georgia | Scott Solomon, MD - (ssolomon@bmtga.com) |
| Northwestern Memorial Hospital Evanston, Illinois | Kehinde Adekola, MD - (kehinde-adekola@northwestern.edu) |
| Oregon Health & Science University/Doernbecher Children's Hospital Portland, Oregon | Eneida Nemecek, MD - (nemeceke@ohsu.edu) |
| Orlando Health Arnold Palmer Hospital for Children Orlando, Florida | Rikin Shah - (rikin.shah@orlandohealth.com) |
| Orlando Health Cancer Institute Bone Marrow Transplant and Cellular Therapy Orlando, Florida | Yasser Khaled, MD - (yasser.khaled@orlandohealth.com) |
| Penn State Milton S. Hershey Cancer Center Hershey, Pennsylvania | Shin Mineishi, MD - (smineishi@pennstatehealth.psu.edu) |
| Phoenix Children's Hospital Phoenix, Arizona | Roberta Adams, MD - (adams.roberta@mayo.edu) |
| Presbyterian St. Luke's/Colorado Blood Cancer Institute Denver, Colorado | Alireza Eghtedar, MD - (alireza.eghtedar@healthonecares.com) |
| Rady Children's Hospital San Diego San Diego, California | Eric Anderson, MD - (eanderson@rchsd.org) |
| Robert Wood Johnson/Cancer Institute of New Jersey New Brunswick, New Jersey | Matthew Matasar, MD, MS - (mm3511@cinj.rutgers.edu) |
| Roger Williams Medical Center Providence, Rhode Island | Todd Roberts, MD - (todd.roberts@chartercare.org) |
| Roswell Park Cancer Institute Buffalo, New York | Kanwaldeep Mallhi, MD - (Kanwaldeep.Mallhi@RoswellPark.org) |
| Rush University Medical Center Chicago, Illinois | |
| Sarah Cannon BMT Program Nashville, Tennessee | |
| Scripps Green Hospital La Jolla, California | James R Mason, MD - (mason.james@scrippshealth.org) |
| Southwest Cancer Treatment & Research Center Lubbock, Texas | |
| Spectrum Health Grand Rapids, Michigan | Aly Abdel-Mageed, MD - (aly.mageed@helendevoschildrens.org) |
| St. Jude Childrens Research Hospital Memphis, Tennessee | Renee Madden, MD - (renee.madden@stjude.org) |
| St. Louis University Medical Center St Louis, Missouri | Sagun Goyal, MD - (sgoyal3@slu.edu) |
| Stanford University Medical Center Stanford, California | Andrew Rezvani, MD - (arezvani@stanford.edu) |
| Stony Brook University Hospital Stony Brook, New York | Michael Schuster, MD - (mschuster@notes.cc.sunysb.edu) |
| Strong Memorial Hospital/University of Rochester Rochester, New York | Omar Aljitawi, MD - (omar_aljitawi@urmc.rochester.edu) |
| Sutter Medical Center Sacramento, California | Elias Kiwan, MD - (elias.kiwan@sutterhealth.org) |
| Texas Children's Hospital - Baylor Medical Center Houston, Texas | George Carrum, MD - (gcarrum@houstonmethodist.org) |
| The Arthur G. James Cancer Hospital/The Ohio State University Medical Center Columbus, Ohio | Sumithira Vasu, MD - (sumithira.vasu@osumc.edu) |
| The Children's Hospital of San Antonio San Antonio, Texas | Martin Andreansky, MD, PhD - (martin.andreansky@bcm.edu) Mark Schambura - (Mark.schambura@christushealth.org) |
| The Jewish Hospital Cincinnati, Ohio | |
| Tufts Medical Center Boston, Massachusetts | Andreas Klein, MD - (aklein2@tuftsmedicalcenter.org) |
| Tulane Medical Center New Orleans, Louisiana | Hana Safa, MD - (hsafah@tulane.edu) |
| UCLA Santa Monica, California | Gary Schiller, MD - (gschiller@mednet.ucla.edu) |
| UCSF (adults) San Francisco, California | |
| UCSF (peds) San Francisco, California | Sandhya Kharbanda, MD - (sandhya.kharbanda@ucsf.edu) |
| Univeristy of Mississippi Medical Center Jackson, Mississippi | Carolyn Bigelow, MD - (cbigelow@umc.edu) |
| University Hospitals Case Medical Center Cleveland, Ohio | Hillard Lazarus, MD - (hillard.lazarus@case.edu) |
| University of Alabama at Birmingham Birmingham, Alabama | Joseph Chewning, MD - (jchewning@peds.uab.edu) |
| University of Arizona Medical Center - Tucson Tucson, Arizona | Emmanuel Katsanis, MD - (katsanis@peds.arizona.edu) |
| University of California San Diego San Diego, California | Dimitrios Tzachanis, MD - (dtzachanis@health.ucsd.edu) |
| University of Chicago Chicago, Illinois | James LaBelle, MD, PhD - (jlabelle@peds.bsd.uchicago.edu) |
| University of Colorado Hospital Aurora, Colorado | Jonathan Gutman, MD - (jonathan.gutman@ucdenver.edu) |
| University of Florida Shands Medical Center Gainesville, Florida | Jordan Milner, MD - (jordan.milner@ufl.edu) |
| University of Illinois at Chicago Chicago, Illinois | Damiano Rondelli, MD - (drond@uic.edu) |
| University of Iowa Iowa City, Iowa | Margarida Silverman, MD - (margarida-silverman@uiowa.edu) |
| University of Kansas Westwood, Kansas | Joseph McGuirk, DO - (jmcguirk@kumc.edu) |
| University of Louisville Hospital - James Brown Cancer Center Louisville, Kentucky | Mohamed Hegazi, MD - (mohamed.hegazi@louisville.edu) |
| University of Massachusetts Worcester, Massachusetts | Jan Cerny, MD - (Jan.Cerny@umassmemorial.org) |
| University of Miami (adult) Miami, Florida | |
| University of Miami (peds) Miami, Florida | Edward Ziga, MD, MPH - (e.ziga@med.miami.edu) |
| University of Michigan Ann Arbor, Michigan | Jessica Yu - (jjxyu@med.umich.edu) |
| University of Nebraska Medical Center Omaha, Nebraska | Phyllis Warkenton, MD - (pwarkent@unmc.edu) |
| University of North Carolina at Chapel Hill Chapel Hill, North Carolina | Anson Snow, MD - (Anson.Snow@unchealth.unc.edu) |
| University of Oklahoma Health Science Center Oklahoma City, Oklahoma | Adam Asch, MD - (adam-asch@ouhsc.edu) |
| University of Pennsylvania/Thomas Jefferson Pittsburgh, Pennsylvania | Elizabeth Hexner, MD - (elizabeth.hexner@uphs.upenn.edu) |
| University of Pittsburgh Medical Center Pittsburgh, Pennsylvania | Alison Sehgal, MD - (sehgalar@upmc.edu) |
| University of Texas Southwestern Medical Center Dallas, Texas | |
| University of Utah Salt Lake City, Utah | Ahmad Rayes, MD - (ahmad.rayes@hsc.utah.edu) |
| University of Virginia Charlottesville, Virginia | Karen Ballen, MD - (KB3TC@hscmail.mcc.virginia.edu) |
| University of Wisconsin - Madison Madison, Wisconsin | Kenneth DeSantes, MD - (kbdesantes@pediatrics.wisc.edu) |
| VA Puget Sound HCS Seattle, Washington | |
| VA Tennessee Valley Healthcare System Nashville, Tennessee | |
| Vanderbilt University Nashville, Tennessee | Michael Byrne, MD - (michael.byrne@vumc.org) |
| Virginia Commonwealth University Richmond, Virginia | John McCarty, MD - (jmccarty@vcu.edu) |
| Wake Forest University Winston-Salem, North Carolina | |
| Washington University St. Louis St Louis, Missouri | Geoffrey Uy, MD - (guy@wustl.edu) |
| Washington University/St. Louis Children's Hospital St Louis, Missouri | Geoffrey Uy, MD - (guy@wustl.edu) |
| West Virginia University Morgantown, West Virginia | Lauren Veltri, MD - (lveltri@hsc.wvu.edu) |
| Westchester Medical Center Valhalla, New York | Mitchell Cairo, MD - (mitchell_cairo@nymc.edu) |
| Western Penn Hospital Pittsburgh, Pennsylvania | John Lister, MD - (Jlister@wpahs.org) |
| Yale New Haven Hospital New Haven, Connecticut | Aaron Flagg, MD - (aron.flagg@yale.edu) |
| Zachary & Elizabeth Fisher Bone Marrow Transplant Program (Brooke Army Medical Center) Fort Sam Houston, Texas | Bradley Beeler, MD - (bradley.w.beeler.mil@health.mil) |
Distress in the Pediatric Oncology Setting: Intervention versus Natural Adaptation
Jewell, Andrea - Andrea.Jewell@vcuhealth.org
Rohan, Jennifer
NCT04409301
HM20019000
Myeloid and Monocytic Leukemia, Mycosis Fungoides, Multiple Myeloma, Melanoma, skin, Lymphoid Leukemia, Lung, Liver, Lip, Oral Cavity and Pharynx, Leukemia, other, Leukemia, Not Otherwise Specified, Larynx, Kidney, Kaposi's sarcoma, Ill-Defined Sites, Hodgkin's Lymphoma, Eye and Orbit, Esophagus, Corpus Uteri, Colon, Cervix, Breast, Brain and Nervous System, Bones and Joints, Anus, Any Site, Non-Hodgkin's Lymphoma, Other Digestive Organ, Other Female Genital, Other Endocrine System, Urinary Bladder, Thyroid, Stomach, Soft Tissue, Small Intestine, Rectum, Prostate, Pancreas, Ovary, Other Urinary, Other Skin, Other Respiratory and Intrathoracic Organs, Other Male Genital, Other Hematopoietic
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Jewell, Andrea - (Andrea.Jewell@vcuhealth.org) |
Longitudinal Cohort Registry of Cancer Survivors
Hong, Susan - susan.hong@vcuhealth.org
Hong, Susan
17880
HM20021510
Anus, Any Site, Bones and Joints, Breast, Brain and Nervous System, Other Hematopoietic, Other Female Genital, Other Endocrine System, Other Digestive Organ, Non-Hodgkin's Lymphoma, Myeloid and Monocytic Leukemia, Mycosis Fungoides, Multiple Myeloma, Melanoma, skin, Lymphoid Leukemia, Lung, Liver, Lip, Oral Cavity and Pharynx, Leukemia, other, Leukemia, Not Otherwise Specified, Larynx, Kidney, Kaposi's sarcoma, Ill-Defined Sites, Hodgkin's Lymphoma, Eye and Orbit, Esophagus, Corpus Uteri, Colon, Cervix, Other Male Genital, Other Respiratory and Intrathoracic Organs, Other Urinary, Urinary Bladder, Thyroid, Stomach, Soft Tissue, Small Intestine, Rectum, Prostate, Pancreas, Ovary, Other Skin
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Hong, Susan - (susan.hong@vcuhealth.org) |
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 Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies (CaDAnCe-101)
BeOne Medicines - clinicaltrials@beonemed.com
NCT05006716
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Inclusion Criteria :
• Confirmed diagnosis (per World Health Organization (WHO) guidelines, unless otherwise noted) of one of the following: Marginal Zone Lymphoma (MZL), R/R follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), R/R diffuse large B-cell lymphoma (DLBCL), or Richter's transformation to DLBCL.
• Participants who have previously received a covalently-binding Bruton´s tyrosine kinase (BTK) inhibitor (BTKi) in any line of therapy must have received treatment with the BTK inhibitor for ≥ 8 weeks (unless reason for discontinuation is intolerance).
• For dose-finding and dose-expansion, participants who had previously received a covalently-binding BTK inhibitor as monotherapy or in combination with other anticancer agents are eligible for the study if they meet any of the following criteria: discontinued the previous BTK inhibitor due to disease progression, experienced disease progression after completing treatment with a BTK inhibitor or discontinued the BTK inhibitor due to toxicity or intolerance.
• Measurable disease by radiographic assessment or serum IgM level (WM only)
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
• Participants enrolling in the dose finding phase of the study may be previously treated with a BTKi or may be naïve to BTKi therapy depending on the diagnosis and country of enrollment; participants with MCL enrolling in the expansion cohorts (Phase 2) must have been treated with a BTKi in a prior line of therapy; CLL/SLL participants, in addition to being treated with a BTKi in a prior line of therapy, must also have received a Bcl-2 inhibitor in a prior line of therapy as well (Phase 2).
• Prior malignancy (other than the disease under study) within the past 2 years, except in situ malignancies that have been curatively resected, localized breast cancer treated with curative intent with no evidence of breast active disease for more than 3 years and receiving adjuvant hormonal therapy, localized Gleason score ≤ 6 prostate cancer undergoing observation or treatment with androgen depravation, or any other cancer treated with curative intent, not on adjuvant treatment, and in the opinion of the investigator is unlikely to recur.
• Requires ongoing systemic treatment for any other malignancy
• Requires ongoing systemic (defined as ≥ 10 mg/day of prednisone or equivalent) corticosteroid treatment.
• Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by B-cell malignancy, regardless of whether participants had received treatment for central nervous system disease
• Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkitt lymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma, Castleman disease, post-transplant lymphoproliferative disorders, hairy cell leukemia, germinal center B-cell (GCB), DLBCL, EBV+ DLBCL NOS, primary DLBCL of the central nervous system (CNS), primary cutaneous DLBCL - leg type, DLBCL associated with chronic inflammation, primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, primary effusion lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, high-grade B-cell lymphoma - NOS, B-cell lymphoma unclassifiable with features intermediate between DLBCL and classical Hodgkin lymphoma, or history of or currently suspected transformation of an indolent lymphoma to an aggressive histology (except for participants with Richter Transformation to DLBCL are eligible for Part 1a, 1c, or Phase 2 and participants with history of follicular lymphoma transforming to non-GCB DLBCL who are eligible for Part 1a, 1c, or Phase 2). Note: Other protocol defined Inclusion/Exclusion criteria may apply.
• Confirmed diagnosis (per World Health Organization (WHO) guidelines, unless otherwise noted) of one of the following: Marginal Zone Lymphoma (MZL), R/R follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), R/R diffuse large B-cell lymphoma (DLBCL), or Richter's transformation to DLBCL.
• Participants who have previously received a covalently-binding Bruton´s tyrosine kinase (BTK) inhibitor (BTKi) in any line of therapy must have received treatment with the BTK inhibitor for ≥ 8 weeks (unless reason for discontinuation is intolerance).
• For dose-finding and dose-expansion, participants who had previously received a covalently-binding BTK inhibitor as monotherapy or in combination with other anticancer agents are eligible for the study if they meet any of the following criteria: discontinued the previous BTK inhibitor due to disease progression, experienced disease progression after completing treatment with a BTK inhibitor or discontinued the BTK inhibitor due to toxicity or intolerance.
• Measurable disease by radiographic assessment or serum IgM level (WM only)
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
• Participants enrolling in the dose finding phase of the study may be previously treated with a BTKi or may be naïve to BTKi therapy depending on the diagnosis and country of enrollment; participants with MCL enrolling in the expansion cohorts (Phase 2) must have been treated with a BTKi in a prior line of therapy; CLL/SLL participants, in addition to being treated with a BTKi in a prior line of therapy, must also have received a Bcl-2 inhibitor in a prior line of therapy as well (Phase 2).
Exclusion Criteria:
• Prior malignancy (other than the disease under study) within the past 2 years, except in situ malignancies that have been curatively resected, localized breast cancer treated with curative intent with no evidence of breast active disease for more than 3 years and receiving adjuvant hormonal therapy, localized Gleason score ≤ 6 prostate cancer undergoing observation or treatment with androgen depravation, or any other cancer treated with curative intent, not on adjuvant treatment, and in the opinion of the investigator is unlikely to recur.
• Requires ongoing systemic treatment for any other malignancy
• Requires ongoing systemic (defined as ≥ 10 mg/day of prednisone or equivalent) corticosteroid treatment.
• Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by B-cell malignancy, regardless of whether participants had received treatment for central nervous system disease
• Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkitt lymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma, Castleman disease, post-transplant lymphoproliferative disorders, hairy cell leukemia, germinal center B-cell (GCB), DLBCL, EBV+ DLBCL NOS, primary DLBCL of the central nervous system (CNS), primary cutaneous DLBCL - leg type, DLBCL associated with chronic inflammation, primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, primary effusion lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, high-grade B-cell lymphoma - NOS, B-cell lymphoma unclassifiable with features intermediate between DLBCL and classical Hodgkin lymphoma, or history of or currently suspected transformation of an indolent lymphoma to an aggressive histology (except for participants with Richter Transformation to DLBCL are eligible for Part 1a, 1c, or Phase 2 and participants with history of follicular lymphoma transforming to non-GCB DLBCL who are eligible for Part 1a, 1c, or Phase 2). Note: Other protocol defined Inclusion/Exclusion criteria may apply.
DRUG: BGB-16673
B-cell Malignancy, Marginal Zone Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoma, Waldenstrom Macroglobulinemia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Diffuse Large B Cell Lymphoma
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Show 109 locations
Study Locations
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| Location | Contacts |
|---|---|
| Aichi Cancer Center Hospital Clinical Oncology Nagoya, Aichi-ken | |
| American Oncology Partners of Maryland Pa Bethesda, Maryland | |
| Arensia Exploratory Medicine Llc Tbilisi, | |
| Arthur Je Child Comprehensive Cancer Centre Calgary, Alberta | |
| Asan Medical Center Seoul, | |
| Augusta University Augusta, Georgia | |
| Austin Health Heidelberg, | |
| British Columbia Cancer Agency the Vancouver Centre Vancouver, British Columbia | |
| CHU Henri Mondor Créteil, | |
| Calvary Mater Newcastle Waratah, New South Wales | |
| Cancer Institute Hospital of Jfcr Kotoku, Tokyo | |
| Centre Henri Becquerel Rouen, | |
| Centre Leon Berard Lyon, | |
| Centre de Lutte Contre Le Cancer Institut Bergonie Bordeaux, | |
| Centro Gaucho Integrado de Oncologia Hospital Mae de Deus Porto Alegre, | |
| Centroricerche Cliniche Di Verona Srl Verona, | |
| Chiba Cancer Center Chiba, | |
| Chu Montpellier Hopital Saint Eloi Montpellier, | |
| Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic) Québec, | |
| Churchill Hospital Oxford University Hospital Nhs Trust Headington, | |
| Columbia University Medical Center New York, New York | |
| Comprehensive Cancer Centers of Nevada Las Vegas, Nevada | |
| Concord Repatriation General Hospital Concord, New South Wales | |
| Cross Cancer Institute Edmonton, Alberta | |
| Dana Farber Cancer Institute Boston, Massachusetts | |
| Derriford Hospital Plymouth, | |
| Dokuz Eylul University Balçova, | |
| Edinburgh Cancer Centre Edinburgh, | |
| Erciyes University Kayseri, | |
| Fondazione Policlinico Universitario Agostino Gemelli Roma, | |
| Fred Hutchinson Cancer Research Center Seattle, Washington | |
| Freeman Hospital Newcastle upon Tyne, | |
| Honor Health Research Institute Scottsdale, Arizona | |
| Hopital Claude Huriez Chu Lille Lille, | |
| Hopital Estaing Clermontferrand, | |
| Hopital de la Pitie Salpetriere Paris, | |
| Hospital Alemão Oswaldo Cruz São Paulo, São Paulo | |
| Hospital Clinico Universitario de Valencia Valencia, | |
| Hospital Erasto Gaertner Curitiba, Paraná | |
| Hospital General Universitario Gregorio Marañon Madrid, | |
| Hospital Nove de Julho Dasa São Paulo, | |
| Hospital Santa Rita de Cassia Afecc Vitória, | |
| Hospital Sirio Libanes Brasilia Brasília, | |
| Hospital Universitario Fundacion Jimenez Diaz Madrid, | |
| Hospital Universitario La Paz Madrid, Madrid, Comunidad de | |
| Hospital Universitario Puerta de Hierro Majadahonda Majadahonda, | |
| Hospital Universitario Vall Dhebron Barcelona, | |
| Inje University Busan Paik Hospital BusanjinGu, Busan Gwang'yeogsi | |
| Institut Paoli Calmettes Marseille, | |
| Instituto Dor de Pesquisa E Ensino Sao Paulo São Paulo, | |
| Istituto Europeo Di Oncologia Milan, | |
| Karmanos Cancer Institute Detroit, Michigan | |
| Karolinska Universitetssjukhuset Solna Stockholm, Stockholm County | |
| Klinikum Grosshadern Ludwig Maximilians Universitat Munchen München, | |
| Klinikum Johannes Gutenberg Universitaet Mainz Mainz, | |
| Linear Clinical Research Nedlands, Western Australia | |
| MD Anderson Cancer Center Houston, Texas | |
| Mary Bird Perkins Cancer Center Baton Rouge, Louisiana | |
| Mayo Clinic Jacksonville Jacksonville, Florida | |
| Mayo Clinic Phoenix Phoenix, Arizona | |
| Mayo Clinic Rochester Rochester, Minnesota | |
| Md Anderson Cancer Center Madrid Spain Madrid, | |
| Memorial Sloan Kettering Cancer Center MSKCC New York, New York | |
| Midwestern Regional Medical Center Zion, Illinois | |
| Mount Sinai Comprehensive Cancer Center Miami Beach, Florida | |
| National Cancer Center Hospital East Kashiwa, | |
| Niguarda Cancer Center Division of Hematology Milan, | |
| Norton Cancer Institute Pavilion Louisville, Kentucky | |
| Nottingham University Hospitals NHS Trust Nottingham, | |
| Ondokuz Mayis University Samsun, | |
| Ospedale San Raffaele Milan, | |
| Perth Blood Institute West Perth, Western Australia | |
| Peter MacCallum Cancer Centre Melbourne, Victoria | |
| Policlinico Sorsola Malpighi, Aou Di Bologna Bologna, | |
| Princess Alexandra Hospital Woolloongabba, | |
| Princess Margaret Cancer Centre Toronto, Ontario | |
| Pusan National University Hospital Busan, | |
| Real E Benemerita Associacao Portuguesa de Sao Paulo São Paulo, | |
| Roswell Park Comprehensive Cancer Center Buffalo, New York | |
| Sahlgrenska University Hospital Hematology Gothenburg, | |
| Sakarya Training and Research Hospital Sakarya, | |
| Samsung Medical Center Seoul, | |
| Seoul National University Hospital Seoul, | |
| Severance Hospital Yonsei University Health System Seoul, | |
| Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein São Paulo, | |
| Southeastern Regional Medical Center Lumberton, North Carolina | |
| St Jamess University Hospital Leeds, | |
| St Vincents Hospital Melbourne Fitzroy, | |
| Stanford Medicine Redwood City, California | |
| Tampa General Hospital Cancer Institute Tampa, Florida | |
| Tennesse Oncology Chattanooga Downtown Chattanooga, Tennessee | |
| Tennessee Oncology, Pllc Nashville Nashville, Tennessee | |
| The Alfred Hospital Melbourne, Victoria | |
| The Catholic University of Korea, Seoul St Marys Hospital SeochoGu, Seoul Teugbyeolsi | |
| The Institute of Oncology, Arensia Exploratory Medicine Chisinau, | |
| UCLA Santa Monica Cancer Care Santa Monica, California | |
| Uchealth North Fort Collins, Colorado | |
| Uniklinik Koeln (Aoer) Cologne, | |
| Universitaetsklinikum Schleswig Holstein Campus Luebeck Lübeck, | |
| Universitaetsklinikum Ulm Ulm, | |
| Universitares Krebszentrum Leipzig Leipzig, | |
| Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden Dresden, | |
| University of Alabama at Birmingham Hospital Birmingham, Alabama | |
| University of Arizona Cancer Center Tucson, Arizona | |
| University of California San Diego (Ucsd) Moores Cancer Center La Jolla, California | |
| University of Iowa Hospitals and Clinics Iowa City, Iowa | |
| Virginia Commonwealth University Massey Cancer Center Richmond, Virginia | |
| Weill Cornell Medical College Newyork Presbyterian Hospital New York, New York | |
| Yokohama Municipal Citizens Hospital Yokohama, |
National Cancer Institute "Cancer Moonshot Biobank" (moonshot)
Castellanos, Natasha, Guzy - castellanosn@vcu.edu
Poklepovic, Andrew, S
NCT04314401
HM20020956
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Inclusion Criteria:
* Is consistent with OR has been diagnosed with one of the following:
* Colorectal cancer: stage IV
* Non-small cell or small cell lung cancer: stage III/IV
* Prostate cancer: metastatic prostate cancer
* Gastric cancer, not otherwise specified (NOS): stage IV
* Esophageal cancer, NOS: stage IV
* Adenocarcinoma of gastroesophageal junction: stage IV
* High grade serous ovarian cancer: stage III/IV
* Invasive breast carcinoma: stage III/IV
* Melanoma: stage III/IV
* Acute myeloid leukemia
* Multiple myeloma
* For the purposes of this study,
* Re-staging is allowed
* Having more than one primary cancer is allowed, if the patient is being treated solely for one of the eligible cancers listed above
* Patient should fit in one of the following four clinical scenarios (a-d)
* Undergoing diagnostic workup for one of the diseases listed for which treatment will likely include a new regimen of standard of care therapy OR
* Scheduled to begin treatment with a new regimen of standard of care therapy OR
* Currently progressing on a regimen of standard of care therapy OR
* Currently being treated with a regimen standard of care therapy, without evidence of progression
* Requirements for fresh tissue biospecimen collections at enrollment:
* For clinical scenarios a, b, and c above, freshly collected tumor tissue or bone marrow (BM) aspirate must be submitted at enrollment
* For clinical scenarios a and b, the fresh tissue collection must be prior to starting therapy
* For clinical scenario a, the biospecimen collection must be part of a standard of care medical procedure
* For clinical scenarios b or c, the biospecimen collection may be part of a standard of care medical procedure OR
* The biospecimen collection may be part of a study-specific procedure ("research only biopsy"), when the patient has a tumor amenable to image guided or direct vision biopsy and is willing and able to undergo a tumor biopsy for molecular profiling
* Note: For research-only biopsies, the biopsy must not be associated with a significant risk of severe or major complications or death; the procedure cannot be a mediastinal, laparoscopic, open or endoscopic biopsy; nor can the procedure be a brain biopsy; nor can the patient be under the age of majority as determined by each U.S. state
* Requirements for archival tissue:
* For clinical scenarios a and b above, archival tissue as outlined below must be submitted IF AVAILABLE
* For clinical scenarios c and d above, archival tissue as outlined below is REQUIRED
* Pre-existing archival material (formalin-fixed, paraffin-embedded \[FFPE\] block, BM aspirate, or unstained slides) that:
* Contains the cancer type for which the participant is enrolled, and
* Was collected no more than 5 years prior to initiation of therapy, and
* Contains at least a surface area of 5 mm\^2 and optimal surface area of 25 mm\^2 or 3-5 mL cryopreserved bone marrow aspirate to yield 200 million bone marrow mononuclear cells, and
* Contains at least 10% tumor content. 70% tumor content is optimal, and
* No more than 1 line of standard of care systemic therapy was administered from the date of archival material collection to the date of initiation of therapy
* Requirements for blood collection: ALL scenarios require fresh blood collection at enrollment
* Blood collection for clinical scenarios a, b, and c must take place within 1 week of fresh tumor specimen collection
* Blood collection for clinical scenario d must take place within 4 weeks of enrollment, and while patient is on treatment
* Age 13 or older
* Any sex
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
* Ability to understand and willingness to sign an informed consent document. Consent may be provided by a Legally Authorized Representative (LAR) in accordance with 45 CFR 46.102(i)
* NCI PDMR INCLUSION CRITERIA: Patients with CRC with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) status
* NCI PDMR INCLUSION CRITERIA: Patients with CRC who are 40 years old or younger at time of collection irrespective of mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) status
* NCI PDMR INCLUSION CRITERIA: Patients with BRCA that are either
* Any race/ethnicity with hormone receptor positive (ER+PR+, ER+PR-, or ER-PR+)
* African American with triple negative (ER-PR-HER2-)
* NCI PDMR INCLUSION CRITERIA: Patients with lung cancer (LCA), prostate cancer (PCA), gastroesophageal cancer (GEC), ovarian cancer (OV), acute myeloid leukemia (AML), multiple myeloma (MML)
Exclusion Criteria:
* Treated with or has already begun treatment with a non-standard of care therapeutic agent (investigational) in an interventional clinical trial
* For the purposes of this study, past enrollment in clinical trials whereby the patient was randomized and treated with standard-of-care anti-cancer treatment (chemotherapy regimen, surgery and radiation therapy) is allowed
* Uncontrolled intercurrent illness that in the physician's assessment would pose undue risk for biopsy
* Use of full dose coumarin-derivative anticoagulants such as warfarin are prohibited. Patients may be switched to low molecular weight (LMW) heparin at physician discretion
* Low molecular weight (LMW) heparin is permitted for prophylactic or therapeutic use
* Factor X inhibitors are permitted
* Use of anti-platelet drugs are permitted
* Stopping the anticoagulation treatment for biopsy, bone marrow aspirate, or resection should be per site standard operating procedure (SOP)
* NCI PDMR EXCLUSION CRITERIA: Patients with complete response
* NCI PDMR EXCLUSION CRITERIA: Patients with invasive fungal infections
* NCI PDMR EXCLUSION CRITERIA: Patients with active and/or uncontrolled infections or who are still recovering from an infection
* Actively febrile patients with uncertain etiology of febrile episode
* All antibiotics for non-prophylactic treatment of infection should be completed at least 1 week (7 days) prior to collection
* No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics
* NCI PDMR EXCLUSION CRITERIA: Patients with human immunodeficiency virus (HIV), active or chronic hepatitis (i.e. quantifiable hepatitis B virus \[HBV\]-deoxyribonucleic acid \[DNA\] and/or positive hepatitis B surface antigen \[HbsAg\], quantifiable hepatitis C virus \[HCV\]-ribonucleic acid \[RNA\]) or known history of HBV/HCV without documented resolution PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, PROCEDURE: Magnetic Resonance Imaging, OTHER: Medical Chart Review, PROCEDURE: Paracentesis, PROCEDURE: Positron Emission Tomography
Acute Myeloid Leukemia, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Clinical Stage IV Esophageal Adenocarcinoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Esophageal Carcinoma, Fallopian Tube Carcinoma, Gastric Carcinoma, Hormone Receptor-Positive Breast Carcinoma, Invasive Breast Carcinoma, Lung Non-Small Cell Carcinoma, Lung Small Cell Carcinoma, Malignant Solid Neoplasm, Melanoma, Metastatic Prostate Carcinoma, Multiple Myeloma, Ovarian Carcinoma, Ovarian High Grade Serous Adenocarcinoma, Primary Peritoneal Carcinoma, Stage III Fallopian Tube Cancer AJCC v8, Stage III Lung Cancer AJCC v8, Stage III Ovarian Cancer AJCC v8, Stage IV Colorectal Cancer AJCC v8, Stage IV Fallopian Tube Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IV Ovarian Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8, Triple-negative Breast Carcinoma
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Study Locations
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| Location | Contacts |
|---|---|
| AIS Cancer Center at San Joaquin Community Hospital Bakersfield, California | |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Audie L Murphy VA Hospital San Antonio, Texas | |
| Aurora Saint Luke's Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Bayhealth Hospital Kent Campus Dover, Delaware | Site Public Contact - (clinical_trials@bayhealth.org) |
| Bayhealth Hospital Sussex Campus Milford, Delaware | Site Public Contact - (clinical_trials@bayhealth.org) |
| Blank Children's Hospital Des Moines, Iowa | |
| Boca Raton Regional Hospital Boca Raton, Florida | |
| Broward Health Medical Center Fort Lauderdale, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| Broward Health North Deerfield Beach, Florida | |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Carle Cancer Center Urbana, 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) |
| Carson Tahoe Regional Medical Center Carson City, Nevada | Site Public Contact - (research@sncrf.org) |
| Centra Alan B Pearson Regional Cancer Center Lynchburg, Virginia | |
| Centro Comprensivo de Cancer de UPR San Juan, | |
| Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Children's Hospital New Orleans New Orleans, Louisiana | |
| Children's Hospital at Montefiore The Bronx, New York | Site Public Contact - (aaraiza@montefiore.org) |
| Chilton Medical Center Pompton, New Jersey | |
| 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 - Town Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | |
| CoxHealth South Hospital Springfield, Missouri | |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dickinson County Healthcare System Iron Mountain, Michigan | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| ECU Health Medical Center Greenville, North Carolina | Site Public Contact - (research@ecuhealth.org) |
| ECU Health Oncology Kinston Kinston, North Carolina | Site Public Contact - (research@ecuhealth.org) |
| East Carolina University Greenville, North Carolina | Site Public Contact - (eubankss@ecu.edu) |
| Edwards Comprehensive Cancer Center Huntington, West Virginia | Site Public Contact - (Christina.Cole@chhi.org) |
| FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst, North Carolina | Site Public Contact - (jcwilliams@firsthealth.org) |
| Freeman Health System Joplin, Missouri | Site Public Contact - (LJCrockett@freemanhealth.com) |
| Gibbs Cancer Center-Gaffney Gaffney, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Gibbs Cancer Center-Pelham Greer, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Good Samaritan Hospital - Cancer Centers of Colorado Lafayette, Colorado | Site Public Contact - (peaksresearch@imail.org) |
| Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis Daphne, Alabama | Site Public Contact - (donna.goggins@infirmaryhealth.org) |
| Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland Saraland, Alabama | Site Public Contact - (donna.goggins@infirmaryhealth.org) |
| Harold Alfond Center for Cancer Care Augusta, Maine | |
| Hartford Hospital Hartford, Connecticut | |
| Heartland Regional Medical Center Saint Joseph, Missouri | Site Public Contact - (Trisha.England2@mymlc.com) |
| Hope Cancer Care of Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.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-Galesburg Galesburg, 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) |
| Intermountain Health Platte Valley Hospital Brighton, Colorado | Site Public Contact - (peaksresearch@imail.org) |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| John H Stroger Jr Hospital of Cook County Chicago, Illinois | |
| Kingman Regional Medical Center Kingman, Arizona | Site Public Contact - (research@sncrf.org) |
| LSU Health Sciences Center at Shreveport Shreveport, Louisiana | |
| Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah, Georgia | Site Public Contact - (underberga@sjchs.org) |
| Lutheran Hospital - Cancer Centers of Colorado Golden, Colorado | Site Public Contact - (peaksresearch@imail.org) |
| MMP Surgical Care Casco Bay Portland, Maine | Site Public Contact - (ClinicalResearch@mmc.org) |
| Maine Children's Cancer Program Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Maine Medical Partners Neurology Scarborough, Maine | Site Public Contact - (ClinicalResearch@mmc.org) |
| Maine Medical Partners Surgical Care Portland, Maine | |
| MaineHealth Cancer Care and IV Therapy - Brunswick Brunswick, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Cancer Care and IV Therapy - Sanford Sanford, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Cancer Care and IV Therapy - South Portland South Portland, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Franklin Hospital Farmington, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth LincolnHealth Hospital Damariscotta, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Maine Medical Center - Biddeford Biddeford, Maine | |
| MaineHealth Maine Medical Center - Portland Portland, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Maine Medical Center- Scarborough Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Stephens Hospital Norway, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Urology - South Portland South Portland, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Waldo Hospital Belfast, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Marion L Shepard Cancer Center - ECU Health Beaufort Hospital Washington, North Carolina | Site Public Contact - (research@ecuhealth.org) |
| Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.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) |
| McFarland Clinic - Ames Ames, Iowa | Site Public Contact - (ksoder@mcfarlandclinic.com) |
| Mercy Clinic-Rolla-Cancer and Hematology Rolla, Missouri | |
| 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 Oncology and Hematology - Clayton-Clarkson Ballwin, Missouri | |
| Mid Coast Hospital Brunswick, Maine | Site Public Contact - (ctsucontact@westat.com) |
| Missouri Baptist Medical Center St Louis, Missouri | |
| Mobile Infirmary Medical Center Mobile, Alabama | |
| Monongalia Hospital Morgantown, West Virginia | |
| 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) |
| 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) |
| Nebraska Cancer Specialists/Oncology Hematology West PC Grand Island, Nebraska | |
| Newton Medical Center Newton, New Jersey | |
| 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 | |
| Northside Hospital Atlanta, Georgia | |
| Novant Health Cancer Institute - Kernersville Kernersville, North Carolina | Site Public Contact - (asmarrs@novanthealth.org) |
| Novant Health Cancer Institute - Mount Airy Mount Airy, North Carolina | Site Public Contact - (asmarrs@novanthealth.org) |
| Novant Health Cancer Institute - Thomasville Thomasville, North Carolina | Site Public Contact - (pjordan@novanthealth.org) |
| Novant Health Forsyth Medical Center Winston-Salem, North Carolina | Site Public Contact - (pjordan@novanthealth.org) |
| Novant Health Presbyterian Medical Center Charlotte, North Carolina | |
| Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa | |
| 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) |
| Our Lady of the Lake Physician Group Baton Rouge, Louisiana | Site Public Contact - (research@ololrmc.com) |
| Overlook Hospital Summit, New Jersey | |
| PCR Oncology Arroyo Grande, California | Site Public Contact - (research@sncrf.org) |
| Penobscot Bay Medical Center Rockport, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Phelps Health Delbert Day Cancer Institute Rolla, Missouri | Site Public Contact - (research@phelpshealth.org) |
| Physicians' Clinic of Iowa PC Cedar Rapids, Iowa | |
| Prisma Health Baptist Hospital Columbia, South Carolina | |
| Prisma Health Greenville Memorial Hospital Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Richland Hospital Columbia, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Roger Williams Medical Center Providence, Rhode Island | Site Public Contact - (fdallesandro@chartercare.org) |
| SMC Center for Hematology Oncology Union Union, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| SSM Health Good Samaritan Mount Vernon, Illinois | Site Public Contact - (gayla.hall@ssmhealth.com) |
| Saint James Community Hospital and Cancer Treatment Center Butte, Montana | |
| Saint Joseph Hospital Nashua, New Hampshire | |
| Saint Joseph Hospital - Cancer Centers of Colorado Denver, Colorado | |
| Saint Mary's Hospital and Regional Medical Center Grand Junction, Colorado | Site Public Contact - (ccrp@co-cancerresearch.org) |
| Saint Mary's Regional Medical Center Reno, Nevada | |
| Saint Vincent Frontier Cancer Center Billings, Montana | |
| Salinas Valley Memorial Salinas, California | Site Public Contact - (tnielsen2@svmh.com) |
| San Juan City Hospital San Juan, | |
| San Juan Community Oncology Group San Juan, | |
| Spartanburg Medical Center Spartanburg, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Swedish Covenant Hospital Chicago, Illinois | |
| Tampa General Hospital Tampa, Florida | Site Public Contact - (syapchanyk@tgh.org) |
| Thomas Hospital Fairhope, Alabama | |
| 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 | |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa | |
| University Medical Center New Orleans New Orleans, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| University of Iowa Healthcare Cancer Services Quad Cities Bettendorf, Iowa | Site Public Contact - (katherine-daprile@uiowa.edu) |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| 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 Medical Center Renton, Washington | Site Public Contact - (research@valleymed.org) |
| Veterans Affairs Loma Linda Healthcare System Loma Linda, California |