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631 Study Matches

A Study of Auxora in Patients With Acute Pancreatitis and Accompanying SIRS (CARPO)

Liisa Tingue - liisa@calcimedica.com

Leichtle, Stefan, W
Phase 2
NCT04681066
HM20018952
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Inclusion Criteria:
All of the following must be met for a patient to be randomized into the study:
• The diagnosis of acute pancreatitis has been established by the presence of abdominal pain consistent with acute pancreatitis together with at least 1 of the following 2 criteria:
• Serum lipase > 3 times the upper limit of normal (ULN);
• Characteristic findings of acute pancreatitis on abdominal imaging;
• The diagnosis of SIRS has been established by the presence of at least two of the following four criteria:
• Temperature < 36°C or > 38°C;
• Heart rate > 90 beats/minute;
• Respiratory rate >20 breaths/minute or arterial carbon dioxide tension (PaCO2) <32 mmHg;
• White blood cell count (WBC) >12,000 mm3, or <4,000 mm3, or > 10% immature (band) forms;
• At least one of the following criteria is also present:
• A peripancreatic fluid collection or a pleural effusion on a contrast-enhanced computed tomography (CECT) performed in the 24 hours before Consent or after Consent and before Randomization;
• Abdominal examination documenting either abdominal guarding or rebound tenderness;
• Hematocrit ≥44% for men or ≥40% for women;
• The patient is ≥ 18 years of age;
• Lack of pancreatic necrosis, pancreatic calcifications, pancreatic pseudocysts and no evidence for previous necrosectomy or pancreatic surgery identified by CECT performed in the 24 hours before Consent or after Consent and before Randomization;
• A female patient of childbearing potential who is sexually active with a male partner is willing to practice acceptable methods of birth control for 180 days after the last dose of study drug. A female patient must not attempt to become pregnant for 180 days;
• A male patient who is sexually active with a female partner of childbearing potential is willing to practice acceptable methods of birth control for 180 days after the last dose of study drug. A male patient must not donate sperm for 180 days;
• The patient is willing and able to, or has a legal authorized representative (LAR) who is willing and able to, provide informed consent to participate, and to cooperate with all aspects of the protocol.
Exclusion Criteria:
Patients with any of the following conditions or characteristics must be excluded from randomizing:
• Expected survival <6 months;
• Suspected presence of cholangitis in the judgment of the treating physician;
• The patient has a known history of:
• Organ or hematologic transplant;
• HIV, hepatitis B, or hepatitis C infection;
• Chronic pancreatitis;
• Current treatment with:
• Chemotherapy;
• Immunosuppressive medications or immunotherapy
• Pancreatic enzyme replacement therapy;
• Hemodialysis or Peritoneal Dialysis;
• The patient is known to be pregnant or is nursing;
• The patient has participated in another study of an investigational drug or therapeutic medical device in the 30 days before randomization;
• Allergy to eggs or known hypersensitivity to any components of study drug.
Drug: CM-4620 Injectable Emulsion or CM-4620-IE, Other: Placebo
Acute Pancreatitis, Systemic Inflammatory Response Syndrome
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Harbor UCLA Medical Center Torrance, California Dyonne Tetangco - (d.tetangco@lundquist.org)
Henry Ford Health System Detroit, Michigan Kathleen Wilson - (kwilso10@hfhs.org)
Houston Methodist Hospital Houston, Texas Anisha Gupte, PhD - (AAGUPTE@houstonmethodist.org)
Icahn School of Medicine at Mount Sinai New York, New York Mitali Ashokkumar Pradhan, MS - (Mitali.Pradhan@mountsinai.org)
John Peter Smith Hospital Fort Worth, Texas Lindsay Crutcher, RN, BSN - (LCrutche01@jpshealth.org) April Bell - (abell01@jpshealth.org)
Kaiser Permanente Los Angeles Medical Center Los Angeles, California Edna Halilbegovic - (Edna.X.Halilbegovic@kp.org)
LA County Hospital - USC Los Angeles, California Alejandro Vazquez - (Alejandro.Vazquez@med.usc.edu)
Long Beach Medical Center Long Beach, California Alexis Suarez - (ASuarez2@memorialcare.org)
Long Island Jewish Hospital New Hyde Park, New York
Lumunis Health Anne Arundel Medical Center Annapolis, Maryland
Methodist Hospital San Antonio, Texas Wiktoria Patek - (Wiktoria.X.Pasek@HealthPartners.Com)
National Jewish Health Denver, Colorado
Northshore University Hospital Glenview, Illinois Meghan Keating - (mkeating1@northwell.edu)
Northwestern University Hospital Chicago, Illinois Thomas Li - (thomasli@northwestern.edu)
Ohio State University Columbus, Ohio Bryan Chu - (ChingMin.Chu@osumc.edu)
Regional One Health Memphis, Tennessee Kimberly Barbee, BSN, RN - (kgbarbee@regionalonehealth.org)
Regions Hospital Saint Paul, Minnesota Wiktoria Patek - (Wiktoria.X.Pasek@HealthPartners.Com)
Robley Rex VA Medical Center Louisville, Kentucky Anne Marie Webb - (anne.webb@louisville.gov)
Sarasota Memorial Health Care System Sarasota, Florida Tamela Fonseca, MSN, RN - (Tamela-Fonseca@smh.com)
St. Luke's Regional Medical Center Sioux City, Iowa Summer Reames, MPH - (reamess@slhs.org)
Tampa General Hospital Tampa, Florida Ashley Barnes, BSN, RN - (ashleynbarnes@tgh.org)
The Stamford Hospital Stamford, Connecticut Carolina Garavito - (CGaravito@stamhealth.org)
Torrance Memorial Medical Center Torrance, California Joy Gonzalez - (HernaJoy.Gonzalez@tmmc.com)
UCLA Ronald Reagan Medical Center Los Angeles, California Melissa Arevalo - (MFArevalo@mednet.ucla.edu)
UT Health Houston Houston, Texas Neomi Sepulveda - (Neomi.Sepulveda@uth.tmc.edu)
University Health System at San Antonio San Antonio, Texas Shawn Lade - (lade@uthscsa.edu)
University of California at Irvine Medical Center Orange, California Cesar Figueroa - (figuercl@hs.uci.edu)
University of Maryland Baltimore, Maryland Kyra Lasko - (Kyra.lasko@som.umaryland.edu)
University of Missouri School of Medicine Columbia, Missouri Mihiri DeSilva - (desilvam@health.missouri.edu)
University of Virginia Charlottesville, Virginia Ashley Simpson - (mailto:APS2H@hscmail.mcc.virginia.edu)
Virginia Commonwealth University Richmond, Virginia
Washington University School of Medicine St Louis, Missouri
Yale University School of Medicine New Haven, Connecticut

Evaluating the Safety and Efficacy of Polyethylene Glycol (PEG) Mediated Fusion (PEG Fusion)

Elizabeth Wysocki, MS - ewysock2@jhu.edu

PHASE2
NCT04789044
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Inclusion Criteria:

• Ages 18-80
• Sustained a complete peripheral nerve injury resulting from upper extremity trauma presenting within 48 hours of injury
• Involves injury or dysfunction to motor and/or sensory function of the axillary, radial, median, ulnar, or musculocutaneous nerve with injury localized between the proximal humerus and the distal flexion crease of the wrist
• Involves a "mixed" nerve segment (i.e., involves a location of any of the above specified nerves that can be expected to have both sensory and motor axons present).
Exclusion Criteria:

• Patients beginning surgery within hours after injury.
• Injury to the brachial plexus nerves
• Injury to the nerves distal to the distal flexion crease of the wrist
• Injury that involves a distal extension of the parent nerve that is considered sensory only (superficial radial nerve, lateral antebrachial cutaneous nerve, etc.) or the posterior interosseus or anterior interosseus nerve distal to the midpoint of the forearm (i.e., distal to what can be considered the main motor branches of the PIN and AIN).
• Previous peripheral nerve injury resulting from trauma, stroke, muscular, neurologic, or neuromuscular disorder
• Documented psychiatric disorder that is expected to result in high probability of self-harm or interfere with study follow-up.
• Severe problems with maintaining follow up (e.g., patients who are prisoners or homeless at time of injury or who are intellectually challenged without adequate family support).
• Not expected to survive the next 30 days due to their injuries/health condition.
• The subject has a known allergy to polyethylene glycol (PEG).
• If any of the assessments cannot be done on the contralateral side (CL) or the MRCC sensory 2PD value is \> 10 mm on the CL side during baseline period, the subject is a screen failure.
• The subject is pregnant and/or is breastfeeding.
• The subject has a significant medical comorbidity precluding immediate repair.
• The subject is not able to strictly adhere to the rules of the current clinical protocol.
DRUG: NTX-001
Peripheral Nerve Injuries
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Johns Hopkins University School Of Medicine Baltimore, Maryland
OrthoCarolina Charlotte, North Carolina
San Antonio Military Medical Center (SAMMC) San Antonio, Texas
University of Maryland Medical Center Shock Trauma Center Baltimore, Maryland
Virginia Commonwealth University Medical Center Richmond, Virginia
Walter Reed National Military Medical Center Bethesda, Maryland
Wellspan Health York, Pennsylvania

Prevalence and Predictors of Hepatic Steatosis in Persons Living With HIV

Jennifer Price, MD, PhD - jennifer.price@ucsf.edu

Sterling, Richard, K
N/A
NCT04795219
HM20021371
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Inclusion Criteria:
* 18 years of age or older * HIV-1, documented historically by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen or plasma HIV-1 RNA. * On ART for 6 months prior to screening with HIV RNA \<200 copies/mL at entry
Exclusion Criteria:
* Evidence of current or prior chronic HBV, as marked by the presence of HBsAg in serum at any time prior to enrollment (patients with isolated antibody to hepatitis B core antigen, anti-HBc total, are not excluded) * Evidence of recent or current HCV as marked by the presence of anti-HCV antibody with detectable HCV RNA in serum within 3 years prior to enrollment. Participants with anti-HCV antibody positivity who have undetectable HCV RNA 3 years prior to enrollment (either due to spontaneous clearance or clearance with treatment) will be eligible to participate if HCV RNA at entry remains undetected. * Known other chronic liver disease, including but not limited to alpha-1- antitrypsin deficiency, Wilson's disease, hemochromatosis, polycystic liver disease, autoimmune hepatitis, and primary biliary cholangitis. Note that alcohol-related liver disease is not exclusionary. * Disseminated or advanced malignancy * Pregnancy * Concomitant severe underlying systemic illness that, in the opinion of the investigator, would interfere with completion of study procedures * Inability to complete a FibroScan® VCTE scan: * Use of implantable active medical device such as a pacemaker or defibrillator * Wound care near the application site of the FibroScan® * Pregnancy * Ascites (fluid in the abdominal area) * Unable or unwilling to complete the FibroScan® without sedation or unable to lie still for sufficient duration to complete the exam * Any other condition that, in the opinion of the investigator, would impede compliance or hinder completion of study procedures * Inability to complete the informed consent process or comply with study procedures
NAFLD, NAFLD-HIV, Hiv
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Duke University Durham, North Carolina Rebecca Mangus - (rebecca.mangus@duke.edu)
Indiana University School of Medicine Indianapolis, Indiana Montreca Releford - (mgrobiso@iu.edu)
John Hopkins University Baltimore, Maryland
University of Alabama Birmingham, Alabama
University of California, San Diego La Jolla, California
University of California, San Francisco San Francisco, California
University of Texas Houston, Texas Marisel Negret-Hernandez - (Marisel.NegretHernandez@uth.tmc.edu)
Virginia Commonwealth University Richmond, Virginia Megan Devore - (megan.devore@vcuhealth.edu)

A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)

Reference Study ID Number: WN42349 www.roche.com/about_roche/roche_worldwide.htm - global-roche-genentech-trials@gene.com

Phase 3
NCT04660539
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Inclusion Criteria:

• Participants aged less than 18 years at the time of informed consent for Study BN40898 can continue treatment with a combination of oral corticosteroids and either AZA or MMF
• Participated in Study BN40898 or Study BN40900 with satralizumab in NMOSD, are on ongoing satralizumab treatment and were anti-aquaporin-4 IgG antibody (AQP4-IgG) seropositive at screening in these studies. Participants with NMOSD who were AQP4-IgG seronegative at screening in Study BN40898 or Study BN40900 can be enrolled if the investigator considers the continued treatment with satralizumab to be beneficial for the participant
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 3 months after the final dose of satralizumab.
Exclusion Criteria:

• Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of study drug. Women of childbearing potential must have a negative urine pregnancy test result on the baseline visit prior to initiation of study drug
• Evidence of any serious uncontrolled concomitant diseases that may preclude participation including nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal/urologic disease, digestive system disease, congenital or acquired severe immunodeficiency
• Known active infection that requires delaying the next satralizumab dose at the time of enrollment
• NMOSD relapse at the time of enrollment
• Laboratory abnormalities at the last assessment in Study BN40898 or Study BN40900 that preclude re-treatment with satralizumab
Drug: satralizumab, Drug: azathioprine (AZA), Drug: mycophenolate mofetil (MMF), Drug: oral corticosteroids
Neuromyelitis Optica Spectrum Disorder
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Study Locations

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Asan Medical Center - PPDS Seoul,
Azienda Ospedaliera Sant'Andrea Rome, Roma
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele Catania, Sicilia
Bilim University Medical Faculty Florence Nightingale Hospital Istanbul,
Central Texas Neurology Consultants Round Rock, Texas
Centre Hospitalier de L'Universite de Montreal (CHUM) Montreal, Quebec
Children's Hospital of Alabama Birmingham, Alabama
China Medical University Hospital Taichung,
Clinical Hospital Centre Osijek Osijek,
Columbus Research and Wellness Columbus, Georgia
Communal NPE Vinnytsia Reg. Clin. Psychoneurolog. Hosp. n.a. O.I. Yushchenko of Vinnytsia RC Vinnytsia, Podolia Governorate
Communal Nonprofit enterprise Ternopil Regional Clinical Psychoneurological Hospital of TRC Ternopil, Volhynian Governorate
Consultants in Neurology LTD Northbrook, Illinois
Great Ormond Street Hospital For Children London,
Hosp. Clinico San Carlos Madrid,
Hospital Clinic de Barcelona Barcelona,
Hospital Kuala Lumpur Kuala Lumpur, FED. Territory of Kuala Lumpur
Instytut Psychiatrii I Neurologii Warszawa,
Jahn Ferenc Del-Pesti Korhaz es Rendelointezet Budapest,
Jefferson Hospital For Neuroscience; Jefferson Neurology Associates Philadelphia, Pennsylvania
Kindai University Hospital Osakasayama-shi, Osaka
Korea University Anam Hospital Seoul,
Kyushu University Hospital Fukuoka,
M.A. - LEK A. M. Maciejowscy SC. Centrum Terapii SM Katowice,
MS Clinical Trials Group Vancouver, British Columbia
Miedzyleski Szpital Specjalistyczny w Warszawie Warszawa, Mazowieckie
Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD Sofia,
Municipal Non-Commercial Enterprise Odesa RMC for Mental Health of Odessa Regional Council Odesa, Kherson Governorate
Municipal Non-Profit Enterprise City Clinical Hospital #16 of Dnipro City Council Dnipro, Katerynoslav Governorate
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS Katowice, Slaskie
National Center of Neurology and Psychiatry Kodaira, Tokyo
National Cheng Kung University Hospital Tainan City,
National Hospital For Neurology and Neurosurgery London,
National Taiwan University Hospital Taipei,
Niigata University Medical & Dental Hospital Niigata,
OSF Saint Francis Medical Center Peoria, Illinois
OhioHealth Research Institute Columbus, Ohio
Osaka University Hospital Suita,
Ruhr Universitat Bochum Bochum,
SC Clubul Sanatatii SRL Campulung,
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie; Klinika Neurologii Lublin,
San Juan MS Center Guaynabo,
Taipei Veterans General Hospital Taipei,
The Neurological Institute PA Charlotte, North Carolina
Tohoku University Hospital Miyagi,
Tokyo Women's Medical University Hospital Shinjuku-ku, Tokyo,
UMHAT 'Dr. Georgi Stranski', EAD Pleven,
University Multiprofile Hospital for Active Treatment Aleksandrovska EAD Sofia,
University of Chicago Chicago, Illinois
University of Kansas Medical Center Kansas City, Kansas
University of Miami Miami, Florida
University of Texas Southwestern Medical Center Dallas, Texas
Uniwersyteckie Centrum Kliniczne WUM, Centralny Szpital Kliniczny Warszawa,
VCU Medical Center Richmond, Virginia
Wayne State University; UHC-4H Detroit, Michigan

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
PHASE3
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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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 - (rryan@cmh.edu)
Children's National Medical Center Washington D.C., District of Columbia Site Public Contact - (OncCRC_OnCall@childrensnational.org)
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio Site Public Contact - (cancer@cchmc.org)
City of Hope 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
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
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 - (cogbchoak@ucsf.edu)
UCSF Medical Center-Mission Bay San Francisco, California Site Public Contact - (cancertrials@ucsf.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 Florida Health Science Center - Gainesville Gainesville, Florida Site Public Contact - (cancer-center@ufl.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)

Preventing Retaliatory Gun Violence in Violently Injured Adults

Nicholas Thomson - Nicholas.Thomson@vcuhealth.org

NA
NCT04813185
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Inclusion Criteria:
* They receive treatment in the hospital for a violence-related injury (e.g., gunshot wound) * They are 18 years or older * They are English speaking * They are eligible for BTG services (which includes living within the BTG catchment area for the hospital; Richmond City and neighboring counties)
Exclusion Criteria:
* Non-English speaking * Age \<18 * Prisoners
BEHAVIORAL: Bridging the Gap
Violence
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Virginia Commonwealth University Richmond, Virginia

Colorectal Health Research Champions

Hunley, Rachel - rachel.hunley@vcuhealth.org

Sheppard, Vanessa, B.
N/A
NCT04812743
HM20017398
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Inclusion Criteria:
the individual is > 30 years of age
• They are literate
• They are/were directly or indirectly impacted by colorectal cancer and interested in becoming a champion for colorectal cancer research. To participate in a chat hosted by the CHRC the inclusion criteria is:
• adult of any gender
• over 30 years of age. Exclusion Criteria for chat hosted by the CHRC: -Those < 30 years of age
Behavioral: Colorectal Health Research Champions
Cancer of Colon, Cancer of Rectum, Rectum, Colon
Prevention
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Virginia Commonwealth University Richmond, Virginia Katelyn Schifano, MS - (schifanokr@vcu.edu)

Crystalloids Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS)

Mason, Jessica - jessica.mason1@vcuhealth.org

de Wit, Marjolein
III
NCT03434028
HM20013528
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Inclusion Criteria:

• Age ? 18 years
• A suspected or confirmed infection (broadly defined by administration or planned administration of antibiotics)
• Sepsis-induced hypotension defined as systolic blood pressure < 100 mmHg or MAP < 65 mmHg after a minimum of at least 1 liter of fluid (*Fluids inclusive of pre-hospital fluids; blood pressure must be below any known or reported pre-morbid baseline).
Exclusion Criteria:

• More than 4 hours elapsed since meeting inclusion criteria or 24 hours elapsed since admission to the hospital
• Patient already received 3 liters of intravenous fluid (includes prehospital volumes)
• Unable to obtain informed consent
• Known pregnancy
• Hypotension suspected to be due to non-sepsis cause (e.g. hemorrhagic shock)
• Blood pressure is at known or reported baseline level
• Severe Volume Depletion from an acute condition other than sepsis. In the judgment of the treating physician, the patient has an acute condition other than sepsis causing (or indicative) of *severe volume depletion; Examples include: Diabetic ketoacidosis, high volume vomiting or diarrhea, hyperosmolar hyperglycemic state, and nonexertional hyperthermia (heat stroke); severe is defined by the need for substantial intravenous fluid administration as part of routine clinical care
• Pulmonary edema or clinical signs of new fluid overload (e.g. bilateral crackles, new oxygen requirement, new peripheral edema, fluid overload on chest x-ray)
• Treating physician unwilling to give additional fluids as directed by the liberal protocol
• Treating physician unwilling to use vasopressors as directed by the restrictive protocol.
• Current or imminent decision to withhold most/all life-sustaining treatment; this does not exclude those patients committed to full support except cardiopulmonary resuscitation
• Immediate surgical intervention planned such that study procedures could not be followed
• Prior enrollment in this study
Drug: Early Vasopressors, Drug: Early Fluids, drug: Ringer's (hartmann's) lactate solution, drug: Plasmalyte (crystalloid) solution, drug: Normal (0.9%, isotonic) saline solution, drug: Norepinephrine
Septic Shock, Symptoms, Signs, and lll-Defined Conditions (780-799)
Fluid management, Sepsis-induced hypotension, vasopressors
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Baystate Medical Center Springfield, Massachusetts
Beth Israel Medical Center New York, New York
Brigham and Women's Hospital Boston, Massachusetts
Brigham and Women's Hospital Boston, Massachusetts
Cleveland Clinic Foundation Cleveland, Ohio
Denver Health Medical Center Denver, Colorado
Duke University Medical Center Durham, North Carolina
Harborview Medical Center Seattle, Washington
Hennepin County Medical Center Minneapolis, Minnesota
Indiana University Health Methodist Hospital Indianapolis, Indiana
Intermountain Medical Center Murray, Utah
LDS Hospital Salt Lake City, Utah
Maine Medical Center Portland, Maine
Massachusetts General Hospital Boston, Massachusetts
McKay-Dee Hospital Ogden, Utah
Medical University of South Carolina Charleston, South Carolina
Montefiore Medical Center The Bronx, New York
Mt. Sinai Hospital Chicago, Illinois
Ohio State University Wexner Medical Center Columbus, Ohio
Oregon Health and Science University OHSU Portland, Oregon
Penn State Hershey Medical Center Hershey, Pennsylvania
Ronald Reagan UCLA Los Angeles, California
St. Joseph Hospital Bethpage, New York
St. Vincent Hospital Green Bay, Wisconsin
Stanford University Hospital Stanford, California
Swedish Hospital First Hill Seattle, Washington
Temple University Hospital Philadelphia, Pennsylvania
UCSF Fresno Fresno, California
UCSF San Francisco San Francisco, California
UPMC Mercy Pittsburgh, Pennsylvania
UPMC Presbyterian Pittsburgh, Pennsylvania
UPMC Shadyside Pittsburgh, Pennsylvania
University Medical Center (LSU) New Orleans, Louisiana
University Of Texas Health Science Center San Antonio, Texas
University Virginia Medical Center Charlottesville, Virginia
University of Arizona Tucson, Arizona
University of Cincinnati Medical Center Cincinnati, Ohio
University of Colorado Hospital Aurora, Colorado
University of Kentucky Lexington, Kentucky
University of Michigan Medical Center Ann Arbor, Michigan
University of Minnesota Medical Center Minneapolis, Minnesota
University of Mississippi Medical Center Jackson, Mississippi
University of North Carolina at Chapel Hill Chapel Hill, North Carolina
University of Utah Health Sciences Center Salt Lake City, Utah
University of Washington Medical Center Seattle, Washington
Utah Valley Regional Medical Center Provo, Utah
VCU Medical Center Richmond, Virginia
Vanderbilt University Medical Center Nashville, Tennessee
Virginia Commonwealth University Richmond, Virginia Mason, Jessica - (jessica.mason1@vcuhealth.org)
Wake Forest Baptist Health Winston-Salem, North Carolina
Yale New Haven Hospital New Haven, Connecticut

IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study

Subotic, Aleksander - aleksandar.subotic@vcuhealth.org

Moores, Russell, Ray
III
NCT03978000
HM20018843
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Inclusion Criteria:

• Gestational age at birth of 23 weeks+0 days to 32 weeks+0 days
• Birth weight 500-1500g
• ? 48 hours of age
• Written informed consent from the subject?s legally authorized representative (LAR)
Exclusion Criteria:

• Participation in any other interventional clinical trial
• Infants in extremis to whom no further intensive care is offered by attending neonatologist
• Infants with, or at a high probability for, early onset sepsis
• Infants with recognized chromosomal anomalies
• Congenital or acquired gastrointestinal disease
• Earlier or planned administration of formulas, foods or supplements that contain added live bacteria
• Infants with known positive maternal HIV status
Drug: IBP-9414, Drug: Placebo, drug: Ibp-9414
Necrotizing Enterocolitis, Certain Conditions Originating in the Perinatal Period (760-779)
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Study Locations

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Location Contacts
Acibadem City Clinic Tokuda Hospital (Tokushukai Medical Corporation - Tokuda Hospital Sofia) (THS) Sofia, Radka Maslarska, MD
Arkansas Children's Hospital Little Rock, Arkansas Vikas Chowdhary, MD
Associates in Newborn Medicine - Saint Paul Saint Paul, Minnesota Andrea Lampland, MD
B?cs-Kiskun County Hospital Kecskem, Gyula Talosi, MD
Banner University Medical Center / University of Arizona Tucson, Arizona Ranjit Kylathu, MD
Baystate Medical Center Springfield, Massachusetts Robert Rothstein, MD
Borsod- Aba?j-Zempl?n County Central Hospital and University Teaching Hospital Miskolc, Ildiko Szucs, MD
C.S Mott Children'S Hospital Ann Arbor, Michigan Lindsay Ellsworth, MD
Carmel Medical Center Haifa, Haifa District Michal Molad, MD
Centre Hospitalier Universitaire de Caen Normandie Caen, Laura Fazilleau, MD
Children'S Hospital At Ou Medicine Oklahoma City, Oklahoma Hala Chaaban, MD
Children'S Hospital of the University of Illinois Chicago, Illinois De-Ann Pillers, MD
Children'S Minnesota Minneapolis, Minnesota Andrea Lampland, MD
Children's Clinic of the Clinical Center of Kragujevac Kragujevac, Dragana Ristic, MD
Children's Hospital at Montefiore The Bronx, New York Thomas Havranek, MD
Children's Hospital of Michigan Detroit, Michigan Jorge Lua, MD
Children's Hospital of Richmind at VCU Richmond, Virginia Russel Moores, MD
Chu Amiens-Picardie - Site Sud Amiens, Andre L?k?, MD
Cohen Children's Medical Center of NY New Hyde Park, New York Shahana Perveen, MD
Connecticut Children'S Medical Center - Uconn - School of Medicine Hartford, Connecticut Leslie Wolkoff, MD
Duke University Durham, North Carolina Patricia Ashley, MD
Geisinger Health Danville, Pennsylvania Ray Hayes, MD
Georgia Regents University Augusta, Georgia Quyen Pham, MD
Good Samaritan Hospital Corvallis, Oregon Rangasamy Ramanathan, MD
Hackensack University Medical Center Hackensack, New Jersey Nicole Spillane, MD
Harvard Medical School - Beth Israel Deaconess Medical Center (Bidmc) Boston, Massachusetts Ivan Frantz, MD
Helen DeVos Children's Hospital Spectrum Health Research Grand Rapids, Michigan Benedict Doctor, MD Amy Pribyl - (Amy.Pribyl@spectrumhealth.org)
Hopital Louis Mourier Colombes, Luc Desfrere, MD
Hospital Clinico San Carlos - Idissc Madrid, Enrique Criado, MD
Hospital General de Alicante Alicante, Caridad Tapia, MD
Hospital Juan XXIII Tarragona, M.Mar Albujar Font, MD
Hospital Universitario HM Puerta del Sur Madrid, Gerardo Romera, MD
Hospital Universitario La Fe Valencia, Maximo Vento Torres, MD
Hospital Universitario La Paz Madrid,
Jackson Madison County General Hospital Jackson, Tennessee Scott Guthrie, MD
Kings County Hospital Center Brooklyn, New York Ivan Hand, MD
LAC & USC Medical Center Los Angeles, California Manoj Biniwale, MD
Loma Linda University Children Hospital Loma Linda, California Elba Fayard, MD
Maria Fareri Children's Hospital - Westchester Medical Center Valhalla, New York Lance Parton, MD
Medical University of South Carolina (MUSC) Charleston, South Carolina Carol Wagner, MD
Memorial Hospital of South Bend South Bend, Indiana Robert White, MD
New Hanover Regional Medical Center Wilmington, Delaware Fernando Moya, MD
North Central Baptist Hospital San Antonio, Texas Kaashif Ahmad, MD
North Shore University Health System Evanston, Illinois Brandy Frost, MD
Northwell Health Cohen Children'S Medical Center of Ny New York, New York Shahana Perveen, MD
Nottingham University Hospitals NHS Trust Nottingham, Don Sharkey, MD
Nottingham University Hospitals, Neonatology: City Campus Nottingham, Dushyant Batra, MD
Rambam Hospital Haifa, Ori Hochwald, MD
SIU School of Medicine - HSHS St. John's Children's Hospital Springfield, Illinois Beau Batton, MD
Samodzielny Publiczny Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego im. prof. Tadeusza Soko?owskiego Szczecin, Agnieszka Kordek, MD
Samodzielny Publiczny Szpital Kliniczny nr 2 Pomorski Uniwersytet Medyczny (PUM) w Szczecinie /Pomeranian Medical University Szczecin, Beata Loniewska, MD
Sharp Memorial Hospital San Diego, California Anup Katheria, MD
Sheridan Clinical Research / Plantation General Hospital Plantation, Florida
Sheridan Healthcare of Texas, P.A./Medical City Plano Plano, Texas Keyaria Gray, MD
Specialized Hospital in Active Treatment of Pediatric Diseases Sofia, Ralitsa Georgieva, MD
Spitalul Clinic Judetean de Urgenta Cluj-Napoca Cluj-Napoca, Gabriela Zaharie, MD
Spitalul Clinic Municipal de Urgenta Timisoara Timișoara, Gabriela Olariu, MD
Spitalul Clinic de Obstetrica si Ginecologie "Filantropia" Bukarest, Mihaela Demetrian, MD
Spitalul Clinic de Obstetrica-Ginecologie "Cuza-Voda" Iasi Ia?i, Maria Stamatin, MD
Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu" Timisoara Timi?oara, Marioara Boia, MD
St David'S Health Care - St. David'S Medical Center/North Austin Medical Center Austin, Texas Anthony Rudine, MD
St. Francis Medical Center Englewood, Colorado Allen Wu, MD
St. Joseph'S Women'S Hospital Tampa, Florida Jenelle Ferry, MD
Szent Gy?rgy University Teaching Hospital of County Fej Sz?kesfeh?rv, Zolt?n Kummer, MD
Szszb County Hospital and J?sa Andr?s University Teaching Hospital Nyiregyhaza, Ferenc Dicso, MD
Tel-Aviv Sourasky Medical Center Tel Aviv, Ronella Marom, MD
Texas Health Presbyterian Hospital - Plano Plano, Texas Antonio Santiago, MD
Tufts Children's Hospital Boston, Massachusetts Rachana Singh, MD
UF Health Jacksonville Jacksonville, Florida Mark Hudak, MD
University Hospital of Obstetrics and Gynecology Maichin Dom - Neonatology Clinic Sofia, Boriana Slancheva, MD
University Multiprofile Hospital for Active Treatment Pleven, Diana Argirova, MD
University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski" - Clinic of Neonatology Pleven, Victoria Atanasova, MD
University of Arkansas for Medical Services Little Rock, Arkansas Vikas Chowdhary, MD
University of Califorina, Los Angeles (UCLA) Los Angeles, California Meena Garg, MD
University of Debrecen Clinical Center Debrecen, Andrea Nagy, MD
University of Florida Health Gainesville, Florida Josef Neu, MD
University of Miami/Holtz Children'S Hospital Miami, Florida Teresa Del-Moral, MD
University of Mississippi Medical Center Jackson, Mississippi Mobolaji Famuyide, MD
University of P?cs Faculty of Medicine P?cs,
University of South Florida Tampa, Florida Jaime Flores-Torres, MD
University of Szeged, Albert Szent-Gy?rgyi Health Centre Szeged, Csaba Bereczki, MD
University of Tennessee Health Science Center Memphis, Tennessee Ajay Talati, MD
University of Texas Medical Branch - Ocr Galveston, Texas Rafael Fonseca, MD
Uniwersytecki Szpital Kliniczny Wroclaw, Lower Silesian Voivodeship Barbara Krolak-Olejnik, MD
Uniwersyteckie Centrum Kliniczne, Warszawskiego Uniwersytetu Medycznego Warsaw, Agnieszka Kociszewska-Najman, MD
Valley Childrens Hospital Madera, California Indira Chandrasekar, MD
Veszpr?m County Csolnoky Ferenc Hospital Veszpr, Eva Szabo, MD
Virginia Commonwealth University Richmond, Virginia Subotic, Aleksander - (aleksandar.subotic@vcuhealth.org)
Wake Health Forest Baptist Health Winston-Salem, North Carolina Peter Porcelli, MD
Wesley Medical Center Wichita, Kansas Barry Bloom, MD
West Virginia University Medical Center Morgantown, West Virginia Mark Polak, MD
Wolfson Children's Hospital Jacksonville, Florida Mark Hudak, MD

Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults

Lantis, Kristin - kllantis@vcu.edu

Maher, Keri
PHASE3
NCT04530565
HM20021870
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Inclusion Criteria:
* ELIGIBILITY CRITERIA FOR PRE-REGISTRATION (TO STEP 0) * Patient must be \>= 18 and =\< 75 years of age * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-3 * Patient must be newly diagnosed with B acute lymphoblastic leukemia (B-ALL) or is suspected to have acute lymphoblastic leukemia (ALL) * Patient must have BCR-ABL1 positive disease. The diagnosis of ALL and the presence of BCR-ABL translocation must be confirmed centrally. Patients can be registered and begin step 1 therapy while awaiting central laboratory eligibility confirmation * NOTE: Bone marrow aspirate and/or peripheral blood specimen must be submitted to the ECOG-American College of Radiology Imaging Network (ACRIN) Leukemia Laboratory at MD Anderson Cancer Center to determine patient's eligibility for registration to Step 1 or confirm patient evaluability. Centrally fluorescence-activated cell sorting (FACS) analysis will be performed to determine B-ALL and to exclude acute myeloid leukemia (AML) or acute bi-phenotypic leukemia and baseline BCR-ABL status will be determined by fluorescent in situ hybridization (FISH). The ECOG-ACRIN Leukemia Laboratory will forward results within 48 hours of receipt of the specimen to the submitting institution. Bone marrow aspirate is to be from first pull (initial or re-direct). Specimens must contain sufficient blast cells. In cases where the bone marrow aspiration may be inadequate, or the bone marrow examination has already been performed prior to study consent and enrollment on Step 0, peripheral blood may be submitted, with recommendation that adequate circulating blasts are present (\> 10%). If a diagnosis of BCR-ABL positive B-ALL has already been established by local Clinical Laboratory Improvement Act (CLIA) certified laboratories, the patient may be registered to step 1 without waiting for central confirmation * Patient must not have a diagnosis of BCR/ABL T-ALL * Patient must not have received chemotherapy for B-ALL. Patients who received up to five days of therapy (hydroxyurea and/or steroids of any kind) with the aim to reduce disease burden prior to study registration to Step 1 are eligible * Patient must not have unstable epilepsy that requires treatment * Patients with lymphoid blast crisis chronic myeloid leukemia (CML) are not eligible * ELIGIBILITY CRITERIA FOR REGISTRATION TO STEP 1 * Patient must have a diagnosis of Philadelphia chromosome positive (Ph+) ALL that has been determined locally and bone marrow and/or peripheral blood was sent and receipt confirmed for central confirmation or determined centrally by the ECOG-ACRIN Leukemia Laboratory at MD Anderson Cancer Center * 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 any woman, 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) * Patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse from the time of step 1 registration, while on study treatment, and until at least six months after the last dose of study treatment * Total bilirubin =\< 3 mg/dL (patients with Gilbert's syndrome must have a total bilirubin =\< 5 mg/dL) (obtained =\< 28 days prior to step 1 registration) * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 X the institutional upper limit of normal (ULN) (obtained =\< 28 days prior to step 1 registration) * Estimated creatinine clearance \> 45 mL/min (based on Cockcroft-Gault equation) (obtained =\< 28 days prior to step 1 registration) * Patients with acute organ dysfunction at step 1 registration, which may be attributed to leukemia can be registered regardless of lab results at presentation. Such patients will be allowed to register and can start Arm A steroid + TKI therapy but will only be allowed to proceed to step 2 randomization if the eligibility criteria outlined is met * Patients who presented with no evidence of acute organ dysfunction but during step 0 experienced a rise in liver enzymes which investigator suspects to be a side effect of any of prescribed drugs, are allowed to be registered regardless of the level of liver enzymes. Step 2 randomization must be withheld until the eligibility criteria outline is met but no more than 14 days after concluding Arm A therapy * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable or on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection must have an undetectable HCV viral load and if indicated, on treatment * Patients with a prior 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 * Patient must not have active concomitant malignancy. Patients on chronic hormonal therapy for breast or prostate cancer or patients treated with maintenance with targeted agents but are in remission with no evidence for the primary malignancies are eligible * Patient must not have complaints of symptoms and/or have clinical and/or radiological signs that indicate an uncontrolled infection or any other concurrent medical condition that could be exacerbated by the treatment or would seriously complicate compliance with the protocol * 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 must be class 2B or better * Investigators must confirm which TKI patient is to receive * NOTE: Patients with known T315I mutation status should receive ponatinib treatment * NOTE: In situations due to insurance coverage issues and the pre-selected TKI is not immediately available, patients can receive dasatinib or imatinib during step 1. The investigator must re-specify dasatinib or ponatinib prior to step 2 randomization and from then on patients must receive the pre-selected TKI only * ELIGIBILITY CRITERIA FOR RANDOMIZATION TO STEP 2 * Patient must have completed at least 7 and no more than 21 days of protocol-treatment on Arm A prior to step 2 randomization. (Days in which arm A therapy was withheld for any reason are not counted) * NOTE: First day of steroids prescription after registration will be considered as the first day of study therapy. The selected TKI must be initiated prior to randomization * Patients who presented with acute organ dysfunction within 2 weeks of registration to step 1 must have total bilirubin =\< 2 X institutional upper limit of normal (ULN) * AST(SGOT) and ALT(SGPT) =\< 2 X the institutional upper limit of normal (ULN) * Estimated creatinine clearance \> 45 mL/min (based on Cockcroft-Gault equation) * Investigators must confirm which TKI patient is to receive. * NOTE: Patients with known T315I mutation status should receive ponatinib treatment * For patients under age 70, intended chemotherapy regimen must have been determined prior to randomization * Patient must not have active central nervous system (CNS) involvement by leukemic blasts. Patients with signs of CNS involvement at presentation are eligible for randomization if clearance of blasts from the cerebrospinal fluid (CSF) is demonstrated * Patients must have resolved any serious infectious complications related to therapy * Any significant medical complications related to therapy must have resolved * ELIGIBILITY CRITERIA FOR REGISTRATION TO STEP 3 (RE-INDUCTION) * Institution has received centralized MRD results confirming positive status * Patients who presented with acute organ dysfunction within 2 weeks of registration to step 1 must have total bilirubin =\< 2 X institutional ULN * Patients who presented with acute organ dysfunction must have AST (SGOT)/ALT (SGPT) =\< 2 X institutional upper limit of normal (ULN) * Patients who presented with acute organ dysfunction must have an estimated creatinine clearance \> 45 mL/min (based on Cockcroft-Gault equation) * Investigators must confirm which TKI patient is to receive * NOTE: Patients with known T315I mutation status should receive ponatinib treatment * For patients under age 70 and previously assigned to Arm C, intended chemotherapy regimen must have been determined * Step 3 (Re-Induction): Patients must have resolved any serious infectious complications related to therapy * Step 3 (Re-Induction): Any significant medical complications related to therapy must have resolved
PROCEDURE: Biospecimen Collection, BIOLOGICAL: Blinatumomab, PROCEDURE: Bone Marrow Aspiration and Biopsy, DRUG: Cyclophosphamide, DRUG: Cytarabine, DRUG: Dasatinib, DRUG: Dexamethasone, DRUG: Doxorubicin Hydrochloride, PROCEDURE: Echocardiography Test, PROCEDURE: Electrocardiography, PROCEDURE: Lumbar Puncture, DRUG: Mesna, DRUG: Methotrexate, PROCEDURE: Multigated Acquisition Scan, DRUG: Ponatinib Hydrochloride, DRUG: Prednisone, DRUG: Vincristine Sulfate
B Acute Lymphoblastic Leukemia With t(9,22)(q34.1,q11.2), BCR-ABL1
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Study Locations

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Location Contacts
Alaska Breast Care and Surgery LLC Anchorage, Alaska
Alaska Oncology and Hematology LLC Anchorage, Alaska
Alaska Women's Cancer Care Anchorage, Alaska
Allegiance Health Jackson, Michigan
Anchorage Associates in Radiation Medicine Anchorage, Alaska
Anchorage Oncology Centre Anchorage, Alaska
Anchorage Radiation Therapy Center Anchorage, Alaska
Augusta University Medical Center Augusta, Georgia Site Public Contact - (ga_cares@augusta.edu)
Baptist Memorial Hospital and Cancer Center-Desoto Southhaven, Mississippi
Baptist Memorial Hospital and Cancer Center-Memphis Memphis, Tennessee Site Public Contact - (BCCclintrials@bmhcc.org)
Bay Area Hospital Coos Bay, Oregon
Cancer Hematology Centers - Flint Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Case Western Reserve University Cleveland, Ohio Site Public Contact - (CTUReferral@UHhospitals.org)
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
Centro Comprensivo de Cancer de UPR San Juan, Site Public Contact - (ecog.rss@jimmy.harvard.edu)
Chelsea Hospital Chelsea, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
City of Hope Comprehensive Cancer Center Duarte, California
Clackamas Radiation Oncology Center Clackamas, Oregon
Community Cancer Institute Clovis, California
CoxHealth South Hospital Springfield, Missouri
Duke University Medical Center Durham, North Carolina
Freeman Health System Joplin, Missouri Site Public Contact - (LJCrockett@freemanhealth.com)
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)
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)
Hawaii Cancer Care Inc-Liliha Honolulu, Hawaii
Heartland Regional Medical Center Saint Joseph, Missouri
Hematology Oncology Consultants-Clarkston Clarkston, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Henry Ford Cancer Institute-Downriver Brownstown, Michigan
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
Henry Ford Medical Center-Columbus Novi, Michigan
Henry Ford Medical Center-Fairlane Dearborn, Michigan
Henry Ford Saint John Hospital - Macomb Medical Macomb, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford West Bloomfield Hospital West Bloomfield, Michigan
Houston Methodist Hospital Houston, Texas
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)
Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana Site Public Contact - (iutrials@iu.edu)
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)
Kapiolani Medical Center for Women and Children Honolulu, Hawaii
Katmai Oncology Group Anchorage, Alaska
Kuakini Medical Center Honolulu, Hawaii
LSU Health Sciences Center at Shreveport Shreveport, Louisiana
Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Lehigh Valley Hospital-Hazleton Hazleton, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Loyola Center for Health at Burr Ridge Burr Ridge, Illinois
Loyola Medicine Homer Glen Homer Glen, Illinois
Loyola University Medical Center Maywood, Illinois
Marjorie Weinberg Cancer Center at Loyola-Gottlieb Melrose Park, Illinois
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
Mayo Clinic in Rochester Rochester, Minnesota
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
Medical College of Wisconsin Milwaukee, Wisconsin
Medical University of South Carolina Charleston, South Carolina Site Public Contact - (hcc-clinical-trials@musc.edu)
Mercy Clinic-Rolla-Cancer and Hematology Rolla, Missouri
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 Oncology and Hematology - Clayton-Clarkson Ballwin, Missouri
MetroHealth Medical Center Cleveland, Ohio
Michigan Healthcare Professionals Pontiac Pontiac, Michigan Site Public Contact - (Emily.Crofts@trinity-health.org)
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)
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)
Newland Medical Associates-Clarkston Clarkston, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Newland Medical Associates-Pontiac Pontiac, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
NorthShore University HealthSystem-Evanston Hospital Evanston, Illinois
NorthShore University HealthSystem-Glenbrook Hospital Glenview, Illinois
NorthShore University HealthSystem-Highland Park Hospital Highland Park, Illinois
Northwestern Medicine Lake Forest Hospital Lake Forest, Illinois
Northwestern University Chicago, Illinois Site Public Contact - (cancer@northwestern.edu)
OSF Saint Anthony's Health Center Alton, Illinois
Ohio State University Comprehensive Cancer Center Columbus, Ohio Site Public Contact - (Jamesline@osumc.edu)
Oncology Hematology Associates of Saginaw Valley PC Saginaw, Michigan
Pacific Gynecology Specialists Seattle, Washington
Pali Momi Medical Center ‘Aiea, Hawaii
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
Phelps Health Delbert Day Cancer Institute Rolla, Missouri
Pocono Medical Center East Stroudsburg, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.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)
Prisma Health Greenville Memorial Hospital Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.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)
Queen's Cancer Cenrer - POB I Honolulu, Hawaii
Queen's Cancer Center - Kuakini Honolulu, Hawaii
Queen's Cancer Center - Pearlridge ‘Aiea, Hawaii
Queen's Medical Center Honolulu, Hawaii
Rambam Medical Center Haifa, Site Public Contact - (y_rozen@rambam.health.gov.il)
Research Medical Center Kansas City, Missouri
Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey
SSM Health Good Samaritan Mount Vernon, Illinois
Saint Charles Health System Bend, Oregon
Saint Charles Health System-Redmond Redmond, Oregon
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 Mary's Oncology/Hematology Associates of West Branch West Branch, Michigan
Saint Patrick Hospital - Community Hospital Missoula, Montana
San Juan City Hospital San Juan,
Shaare Zedek Medical Center Jerusalem,
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)
Straub Clinic and Hospital Honolulu, Hawaii
Swedish Cancer Institute-Edmonds Edmonds, Washington
Swedish Cancer Institute-Issaquah Issaquah, Washington
Swedish Medical Center-Ballard Campus Seattle, Washington
Swedish Medical Center-Cherry Hill Seattle, Washington
Swedish Medical Center-First Hill Seattle, Washington
The Cancer Center of Hawaii-Liliha Honolulu, Hawaii
The Cancer Center of Hawaii-Pali Momi ‘Aiea, Hawaii
The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky
Thomas Jefferson University Hospital Philadelphia, Pennsylvania Site Public Contact - (ONCTrialNow@jefferson.edu)
Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Medical Center - Brighton Brighton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Medical Center - Canton Canton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California Site Public Contact - (ucstudy@uci.edu)
UC San Diego Moores Cancer Center La Jolla, California Site Public Contact - (cancercto@ucsd.edu)
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine, California Site Public Contact - (ucstudy@uci.edu)
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 Oncology Associates Clovis, California
University of Alabama at Birmingham Cancer Center Birmingham, Alabama Site Public Contact - (tmyrick@uab.edu)
University of Cincinnati Cancer Center-UC Medical Center Cincinnati, Ohio Site Public Contact - (cancer@uchealth.com)
University of Cincinnati Cancer Center-West Chester West Chester, Ohio Site Public Contact - (cancer@uchealth.com)
University of Hawaii Cancer Center Honolulu, Hawaii
University of Kansas Cancer Center Kansas City, Kansas Site Public Contact - (KUCC_Navigation@kumc.edu)
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 Michigan Comprehensive Cancer Center Ann Arbor, Michigan Site Public Contact - (slusserb@med.umich.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 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 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)
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
Vanderbilt Breast Center at One Hundred Oaks Nashville, Tennessee
Vanderbilt University/Ingram Cancer Center Nashville, Tennessee
Vanderbilt-Ingram Cancer Center Cool Springs Franklin, 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)
Wayne State University/Karmanos Cancer Institute Detroit, Michigan Site Public Contact - (ctoadmin@karmanos.org)
Weisberg Cancer Treatment Center Farmington Hills, Michigan
Wilcox Memorial Hospital and Kauai Medical Clinic Lihue, Hawaii
Yale University New Haven, Connecticut Site Public Contact - (canceranswers@yale.edu)

Registry of Patients With a Diagnosis of Spinal Muscular Atrophy (SMA) (RESTORE)

Novartis Gene Therapies - novartis.email@novartis.com

Johnson, Nicholas, E
N/A
NCT04174157
HM20015046
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Inclusion Criteria:
* Patients treated with OAV-101 with a genetically confirmed diagnosis of SMA regardless of the date of diagnosis. * Appropriate consent/assent has been obtained for participation in the registry
Exclusion Criteria:

• Currently enrolled in an interventional clinical trial involving an investigational medicinal product to treat SMA. Note: Patients who are participating in a Compassionate Use Program (CUP) for OAV-101 (Zolgensma) such as a Managed Access Program (MAP), an Expanded Access Program (EAP), Single Patient Investigational New Drug (IND) (SPI) or Named Patient Program (NPP) are eligible to enroll in the registry regardless of the date of a genetic or clinical diagnosis of SMA.
OTHER: Prospective observational registry, DRUG: Zolgensma
Spinal Muscular Atrophy (SMA)
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Study Locations

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Location Contacts
Adventist Health System - Florida Orlando, Florida
Aichi Medical University Hospital Nagakute-shi, Aichi,
Akron Children's Hospital Akron, Ohio
Almazov National Medical Research Centre Saint Petersburg, Natalia Petrova, MD - (natalja5@yandex.ru)
Arkansas Children's Hospital Little Rock, Arkansas Kapil Arya - (karya@uams.edu)
Atlantic Health System Morristown, New Jersey Darius Adams, MD - (adamsd@mail.amc.edu)
CHRISTUS Health Tyler, Texas Melissa Svoboda, MD - (melissa.svoboda@bcm.edu)
CHUC - Hospital Pediatrico Coimbra, Joana Ribeiro, MD - (10675@chuc.min-saude.pt)
Center Hospital of the National Center for Global Health and Medicine Shinjyu-Ku,
Centro Hospitalar Universitaria de Lisboa Central, EPE Lisboa, Jose Pedro Vieira, MD - (Jose.vieira@chlc.min-suade.pt)
Centro Hospitalar Universitario Lisboa Norte, EPE Lisboa, Teresa Moreno, MD - (ped.ensaioscaml@gmail.com) Joana Coelho, MD - (joanamalveirocoelho@gmail.com)
Centro Hospitalar Universitario de Porto, EPE Porto, Cristina Garrido, MD - (cgarridopt@gmail.com)
Centro Hospitalar Universitario de Sao Joao, EPE Porto, Raquel Carvalho Sousa, MD - (Rccarvalhosousa@gmail.com)
Centrul de Recuperare pentru Copii dr. Nicolae Robanescu Bucharest, Madalina Cristina Leanca, MD - (mada332@yahoo.com)
Chang Gung Memorial Hospital Linkou Branch Taoyuan City Singapore, I-Jun CHOU, MD - (ijun@adm.cgmh.org.tw)
Chiba children's Hospital Chiba-shi, Chiba
Child Neurology Consultants of Austin Austin, Texas
Children's Health Dallas, Texas
Children's Hospital Colorado Aurora, Colorado Margaret Finlay - (margaret.finlay@childrenscolorado.org)
Children's Hospital of Los Angeles Los Angeles, California Martha Arellano-Garcia - (margarcia@chla.usc.edu) Claudia Dozal - (cdozal@chla.usc.edu)
Children's Hospital of Orange County Orange, California Amanda Fernandez, MD - (afernandez@choc.org) Linda Do - (Linh.Do@choc.org)
Children's Hospital of Wisconsin Milwaukee, Wisconsin Rupa Nallamothu - (rnallamothu@mcw.edu) Rebecca Rehborg - (rrehborg@mcw.edu)
Children's Hospital of the King's Daughters Norfolk, Virginia Cassandra Todd - (Cassandra.Todd@chkd.org)
Children's University Hospital-UCD School of Medicine Scoil an Leighis Dublin, Declan O Rourke, MD - (declan.orourke@cuh.ie)
China Medical University Hospital Taichung, I-Ching Chou, MD - (004009@tool.caaumed.org.tw) - (004009@tool.caaumed.org.tw)
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio Emily Hunsaker - (emily.hunsaker@cchmc.org)
Connecticut Children's Medical Center Hartford, Connecticut Hendriana Nielsen - (HNielsen@connecticutchildrens.org) James Santanelli - (jsantanelli@connecticutchidlrens.org)
Cook Children's Fort Worth, Texas Kayla Blough - (Kayla.blough@cookchildrens.org)
Dokkyo Medical University Saitama Medical Center Koshigaya, Saitama
Duke Health Durham, North Carolina Karen Cornett - (k.cornett@duke.edu)
Fujita Health University Hospital Aichi,
Fukui Prefectural Hospital Fukui,
General Hospital of Thessaloniki Ippokrateio Thessaloníki, Dimitrios Zafeiriou, MD - (dizafeir@auth.gr)
Gifu Prefectural General Medical Center Gifu,
Golisano Children's Hospital of Southwest Florida Fort Myers, Florida Britt Stroud, MD - (britt.stroud@leehealth.org) Molly Arnstrom - (Molly.arnstrom@leehealth.org)
Hamamatsu University School of Medicine, University Hospital Hamamatsu,
Indiana University Health University Hospital (IUHUH) Indianapolis, Indiana Marcia Felker, MD - (mamccann@iupui.edu) Leanne Dunn - (lkhernan@iu.edu)
Jackson South Medical Center Palmetto Bay, Florida Paula Schleifer, MD - (pschleifer@fcneurology.net)
Jichi Medical University Hospital Tochigi,
Kagawa University Hospital Kagawa,
Kanagawa Children's Medical Center Yokohama, Kanagawa
Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City, Yuh-Jyh Jong, MD - (yjjong@gap.kmu.edu.tw)
Kumamoto University Hospital Kumamoto,
Kurume University Hospital Kurume-shi, Fukuoka
Kyungpook National University Hospital Daegu, Jeong Jin Yun, SC - (sylyu01@naver.com)
Loma Linda University Health Loma Linda, California
Methodist Le Bonheur Healthcare Germantown, Tennessee Farimah Salami - (Farimah.Salami@lebonheur.org)
Miyagi Children's Hospital Sendai-shi, Miyagi
Multicare Health System Tacoma, Washington Beky Stone - (Becky.Stone@multicare.org)
National Taiwan University Hospital Taipei, Yin-Hsiu CHIEN, MD - (chienyh@ntu.edu.tw)
Nationwide Children's Hospital Columbus, Ohio Megan Waldrop - (Megan.WAldrop@nationwidechildrens.org)
Nicklaus Children's Hospital Miami, Florida
Nikko Memorial Hospital Hokkaido,
Obihiro Kosei Hospital Hokkaido, Obihiro-shi
Oklahoma University Medical Center Oklahoma City, Oklahoma
Oregon Health and Science University Portland, Oregon Bryn McCarthy - (McCarbry@ohsu.edu)
Penn State Hershey Hershey, Pennsylvania Ellen Stoute - (estoute@pennstatehealth.psu.edu) Ashutosh Kumar, MD - (akumar5@pennstatehealth.psu.edu)
Penteli Children's Hospital Penteli, Attikis Chrysanthi Tsimakidi - (Chrysanthit@hotmail.com)
Phoenix Children's Hospital Phoenix, Arizona Alison Lane - (alane@phoenixchildrens.com)
Prisma Health Greenville, South Carolina Addie Hunnicutt Hunnicutt - (ahunnicutt@ghs.org) Addie Hunnicutt - (ahunnicutt@ghs.org)
Pusan National University Yangsan Hospital Yangsan, Gyeongsangnam-do Yunjin Lee, MD - (jinnyeye@hanmail.net)
Rady Children's Hospital San Diego San Diego, California Chamindra Konersman, MD - (ckonersman@health.ucsd.edu) Napat Intarachumnum - (nintarachumnum@health.ucsd.edu)
Samsung Medical Centre Seoul, Min Jeong Kim, SC - (tgkimmj@naver.com)
Sapporo Medical University Hospital Sapporo, Hokkaido
Schneider- Children's Medical Center Petah tikva, Sharon Aharoni, MD - (Sharonah@clalit.org.il)
Seattle Children's Seattle, Washington Marissa Robertson - (Marissa.Robertson@seattlechildrens.org)
Seoul National University Bundang Hospital Seongnam-si, Gyeonggi-do, Anna Cho, MD - (annacho77@snu.ac.kr)
Seoul National University Children's Hospital Seoul, Miae Kim, SC - (sellykma@snuh.org)
Severance Hospital Seoul, Hoonchul Kang, MD - (HIPO0207@yuhs.ac)
Shiga Medical Center for Children Moriyama-shi, Shiga
Soroka Medical Centre Be'er Sheva, Iris Noyman, MD - (IRISN@clalit.org.il)
Spitalul Clinic de Psihiatrie Bucharest, Loana Minciu, MD - (Iminciu@yahoo.com)
St. Sophia Children's Hospital Thessaloniki, Maria Roser-Pons, MD - (roserpons@med.uoa.gr)
Taipei Veterans General Hospital Taipei, Dau-Ming NIU, MD - (dmniu1111@yahoo.com.tw)
Tel-Aviv Sourasky Medical Center Tel Aviv, Aviva Fattal, MD - (afatal@post.tau.ac.il)
Texas Children's Hospital Houston, Texas Felize Singleton - (felize.singleton@bcm.edu)
The State University of New York Stony Brook, New York Christine Pol - (Christiana.Pol@stonybrookmedicine.edu)
Tokyo Medical University Hospital Shinjuku-Ku,
University General Hospital Attikon Athens, Attica Argyrios Dinopoulos, MD - (argidino@yahoo.com)
University Hospitals Cleveland, Ohio
University of California Davis Health System Sacramento, California Rachel (Ja Yoon) Baek - (jrbaek@ucdavis.edu)
University of California Los Angeles Health Los Angeles, California Huynh Jennifer - (JenniferH@mednet.ucla.edu)
University of Iowa Iowa City, Iowa Chandra Miller - (Chandra-miller@uiowa.edu) Carrie Stephan - (Carrie-stephan@uiowa.edu)
University of Kansas Medical Center Kansas City, Kansas Rebecca Clay - (rclay@kumc.edu)
University of Louisville Louisville, Kentucky Lauren Evanczyk - (Lauren.evanczyk@nortonhealthcare.org)
University of Minnesota Minneapolis, Minnesota Seth Stafki, MD - (stafk006@umn.edu)
University of Missouri Health System Columbia, Missouri Anne Bonnett - (bonnetta@health.missouri.edu)
University of Pittsburgh Medical Center Pittsburgh, Pennsylvania Emma Sekscinski - (ecs112@pitt.edu)
University of Rochester Medical Center Rochester, New York Bohoon Lee - (Bohoon_Lee@URMC.Rochester.edu) Kim Hart Kim_ - (Hart@URMC.Rochester.edu)
University of Utah Salt Lake City, Utah Sarah Moldt - (sarah.moldt@hsc.utah.edu)
University of Virginia Health System Charlottesville, Virginia Chelsea Masterson - (CDM5FA@hscmail.mcc.virginia.edu)
University of Wisconsin Madison, Wisconsin Maggie Chilsen - (mchilsen@clinicaltrials.wisc.edu)
Uniwersytecki Szpital Dzieciec Lublin, Magdalena Chroscinska-Krawczyk, MD - (magdalenachk@wp.pl)
Valley Children's Healthcare Madera, California Raymund David, MD - (RDavid@valleychildrens.org)
Virginia Commonwealth University Health System Richmond, Virginia Ana Rosa Rezeq - (Anarosa.rezeq@vcuhealth.org)
Washington University School of Medicine in St. Louis St Louis, Missouri Natalie Goedeker - (ngoedeker@wustl.edu)
Wolfson Medical Center Holon, Mira Ginsberg, MD - (miraginsberg@gmail.com)
Yale-New Haven Health System New Haven, Connecticut Catherine Tsao - (catherine.tsao@yale.edu)
Yongin Severance Hospital Yongin-si, Lae-song Noh, SC - (YI771998@yuhs.ac)

Post Approval Study for Treatment of Drug-resistant Adult and Pediatric Primary FSGS Using the LIPOSORBER® LA-15 System (FSGSALLAGE)

Ayaka Kitamura - Ayaka.Kitamura1@kaneka.co.jp

NA
NCT04065438
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Inclusion Criteria:
A patient is deemed suitable for inclusion in the study if the patient has nephrotic syndrome associated with primary FSGS when: • Standard treatment options, including corticosteroid and/or calcineurin inhibitors, are unsuccessful or not well tolerated and the patient's glomerular filtration rate (GFR) ≥ 45 ml/min/1.73 m2. or • The patient is post renal transplantation.
Exclusion Criteria:
General Exclusion Criteria
• Patient is greater than 75 years of age at the start of the treatment period or less than 22
• The patient is unwilling or unable to sign and date the informed consent
• Pregnant, lactating, or planning to become pregnant prior to completing the study (Note: The safety of the use of LIPOSORBER® in pregnant women has not been studied. There may be unknown risks to an embryo/fetus. Sexually active women of childbearing potential should avoid pregnancy during the use of the LIPOSORBER device and throughout the study duration.)
• Unable or unwilling to comply with the follow-up schedule
• Simultaneously participating in another investigational drug or device study
• Body weight \< 15 kg (33.1 lbs) Medical Exclusion Criteria
• Currently being administered ACE inhibitors that cannot be withheld for at least 24 hours prior to each apheresis treatment (Note: The time period to withhold ACE inhibitors should be prolonged, if determined by the treating physician, considering each individual's renal function and the biological half-life of the ACE-inhibitor currently in use.)
• Currently being administered antihypertensive drugs other than ACE inhibitors (e.g., ARBs) that cannot be withheld on the day of apheresis until after the procedure
• Medical condition or disorder that would limit life expectancy to less than the primary clinical study endpoint or that may cause noncompliance with the study plan or confound the data analysis
• Hypersensitivity to dextran sulfate, heparin, or ethylene oxide
• Adequate anticoagulation cannot be achieved due to severe hemophilia, severe hemorrhage diathesis, severe gastrointestinal ulcers, or are recipients of vitamin K antagonist medications
• Extracorporeal circulation therapy with LIPOSORBER® LA-15 System cannot be tolerated due to severe cardiac insufficiency, acute myocardial infarction, severe cardiac arrhythmia, acute apoplexy, severe uncontrollable hypertension, or severe uncontrollable hypotension Note: Severe uncontrollable hypotension/hypertension indicates the cases with systolic and/or diastolic blood pressure ≤ 5th percentile for age, gender, and height.
• Cardiac impairments such as uncontrolled arrhythmia, unstable angina, decompensated congestive heart failure, or valvular disease
• Functional thyroid disease or liver abnormalities
• Unresolved systemic or local infection that could affect the clinical study outcomes
DEVICE: LIPOSORBER® LA-15
Focal Segmental Glomerulosclerosis
FSGS, Liposorber
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Study Locations

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Location Contacts
Akron Children's Hospital Akron, Ohio Rupesh Raina, MD - (apokelsek@akronchildrens.org)
Children's Hospital of Richmond at VCU Richmond, Virginia
Helen DeVos Children's Hospital Grand Rapids, Michigan
Loma Linda University Children's Hospital Loma Linda, California
Loma Linda University Hospital Loma Linda, California Daisy Sekly - (DSekly@llu.edu)
Medical University of South Carolina Charleston, South Carolina Linda Walker - (walkerlp@musc.edu)
Medical University of South Carolina Children's Hospital Charleston, South Carolina
Nemours/Alfred I DuPont Hospital for Children Wilmington, Delaware Joshua J Zaritsly, MD - (joshua.zaritsky@nemours.org)
University of North Carolina Chapel Hill, North Carolina Anne Froment - (anne_froment@med.unc.edu)
Weill Cornell Medicine / NewYork-Presbyterian New York, New York

Study to Test OBI-3424 in Patients With T-Cell Acute Lymphoblastic Leukemia (T-ALL) or T-Cell Lymphoblastic Lymphoma (T-LBL)

Weir, Caryn, R - cweir@vcu.edu

Maher, Keri
PHASE1
NCT04315324
HM20021956
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Inclusion Criteria:
* Patients must have a diagnosis of relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) based on World Health Organization (WHO) classification. Patients with relapsed/refractory T-cell lymphoblastic lymphoma are eligible if lymphoblasts are \>= 5% in the bone marrow or in the peripheral blood by morphology or flow cytometry * Patients must have evidence of acute leukemia in their peripheral blood or bone marrow. Patients must have \>= 5% lymphoblasts in the peripheral blood or bone marrow within 14 days prior to registration. Patients with only extramedullary disease are not eligible * Patients ≥ 18 years of age must be refractory to or have relapsed following a standard induction chemotherapy. Patients \< 18 years of age must have relapsed or must be refractory after 2 or more chemotherapy cycles (example: induction and consolidation) * A standard chemotherapy induction regimen is defined as any program of treatment that includes: * Vincristine and corticosteroids plus at least one more chemotherapy agent * Cytarabine and anthracycline, or * High dose cytarabine (defined as at least 1 gr/m\^2 per individual dose unless adjustments were required for renal/liver function) * Patients must have no evidence of central nervous system disease within 28 days prior to registration based on cerebrospinal fluid (CSF) studies. Patients with clinical signs or symptoms consistent with central nervous system (CNS) involvement must have a lumbar puncture which is negative for CNS involvement; the lumbar puncture must be completed within 28 days prior to registration. Patients with CNS1 or CNS2 are eligible; however patients with CNS3 are not eligible * Note that the patients may receive intrathecal chemotherapy with the initial lumbar puncture. This may count as the first dose of intrathecal therapy required as part of the study * Prior nelarabine therapy is not required. In addition, for patients ≥ 18 years of age who received nelarabine during initial induction or post-remission treatment are eligible only if the physician does not feel they would benefit from other, multi-agent chemotherapy * Patients must not have had chemotherapy or investigational agents within 14 days prior to registration except for corticosteroids, oral 6-mercaptopurine, oral methotrexate, vincristine, intrathecal chemotherapy, or hydroxyurea. For participants who have received radiation therapy, at least 7 days must have elapsed from the end of radiation prior to registration and participants must not currently be experiencing toxicities from radiation therapy * Patients must not have undergone allogeneic hematopoietic transplant within 90 days prior to registration * Patients must have no evidence of active \>= grade 2 acute graft versus host disease (GVHD) or moderate or severe limited chronic GVHD. Patients must have no history of extensive GVHD of any severity within 90 days prior to registration. Patients who are post-transplant must be off calcineurin inhibitors for at least 21 days to be eligible. Extensive GVHD is defined as 1) generalized skin involvement or 2) localized skin involvement and/or hepatic dysfunction plus liver histology or cirrhosis or involvement of eye or minor salivary organ or oral mucosa or any other target organ * Patients must be \>= 12 years of age * Patients ≥ 16 years of age must have a Zubrod Performance Status of 0-3. Patients \< 16 years of age must have a Lansky score of ≥ 50 * Patients must not have systemic fungal, bacterial, viral or other infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment) within 14 days prior to registration * Patients ≥ 18 years of age must have creatinine clearance \> 30 mL/min within 14 days prior to registration according to the Cockcroft Gault equation * Patients 12-17 years of age must have adequate renal function within 14 days prior to registration defined as serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN) according to age or a calculated estimated glomerular filtration rate (eGFR) (based on Schwartz formula) or radioisotope glomerular filtration rate (GFR) ≥ 50ml/min/1.73 m\^2 * Patients must have direct bilirubin =\< 1.5 x institutional upper limit of normal (ULN) within 14 days prior to registration * Patients must have alanine aminotransferase (ALT) =\< 3.0 x institutional upper limit of normal (ULN) or =\< 5.0 x ULN (if thought to be related to leukemic involvement) within 14 days prior to registration * Prothrombin time (PT)/partial thromboplastin time (PTT)/ fibrinogen (as clinically indicated for example but not limited to history of bleeding or active bleeding, concern for disseminated intravascular coagulation) (within 14 days prior to registration to obtain baseline measurements) * From metabolic panel (comprehensive or basic): sodium, potassium, chloride, carbon dioxide (CO2), and blood urea nitrogen (BUN) (within 14 days prior to registration to obtain baseline measurements) * Patients must be able to safely discontinue use of strong inhibitors/inducers of CYP3A4 or PgP-g-p and must be able to safely discontinue use of naproxen for 48 hours before and after each dose of OBI-3424 * Patients with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test within 6 months prior to registration. (HIV viral load testing is required only for patients with known HIV infection). Patients must not be receiving antiviral therapies that are known strong inhibitors or inducers of CYP3A4 * Patients with evidence of chronic hepatitis B virus (HBV) infection may be eligible provided that they have an undetectable HBV viral load within 28 days prior to registration. Patients may be currently receiving HBV treatment. (HBV viral load testing is required only for patients with known HBV infection). Patients must not be receiving antiviral therapies that are known strong inhibitors or inducers of CYP3A4 * Patients with known history of hepatitis C virus (HCV) infection may be eligible provided that they have an undetectable HCV viral load within in 28 days prior to registration. Patients may be currently receiving treatment. (HCV viral load testing is required only for patients with known HCV infection). Patients must not be receiving antiviral therapies that are known strong inhibitors or inducers of CYP3A4 * Patients must not have a known history of prolonged QT interval by Fridericia (QTcF) (interval \> 450 msec for males; \> 470 msec for females). Patients that had transient prolongation of QTc secondary to medications or electrolyte abnormalities are not excluded if the QTc normalized and remain within acceptable QTcF range (interval \> 450 msec for males; \> 470 msec for females). Additionally, suspected medications should be no longer required or used, and electrolyte abnormalities must have normalized * Patients must not be pregnant or nursing due to the teratogenic potential of the drug used on this study. Females of reproductive potential must have a negative serum pregnancy test within 14 days prior to registration. Women/men of reproductive potential must have agreed to use an effective contraceptive method during and up to 6 months after treatment. 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 * Patients must not have other active malignancies for which they have received treatments within 6 months prior to registration excluding localized malignancies that do not require systemic treatment * Patients must agree to have bone marrow and blood specimens submitted for MRD testing * Patients must be offered the opportunity to participate in specimen banking. With patient consent, residuals from specimens submitted will be retained and banked for future research * Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with fedral, local, institutional and Central Institutional Review Board (CIRB) guidelines unless they are unable to provide consent based on age (\< 18 years) or based on impaired decision-making capabilities. For patients \< 18 years of age or with impaired decision making capabilities, parents or other legally authorized representatives must sign and give informed consent on behalf of study participants in accordance with applicable federal, local, institutional and CIRB regulations * 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 * This trial will use a slot reservation system to enroll the Phase I portion of the study. Patients planning to enroll at this phase of the study must first have a slot reserved in advance of the registration. All site staff will use OPEN to create a slot reservation
DRUG: AKR1C3-activated Prodrug AST-3424, PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Computed Tomography
Recurrent T Acute Lymphoblastic Leukemia, Refractory T Acute Lymphoblastic Leukemia, Refractory T Lymphoblastic Lymphoma, T Lymphoblastic Lymphoma
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Show 163 locations

Study Locations

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Location Contacts
Abbott-Northwestern Hospital Minneapolis, Minnesota
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
Augusta University Medical Center Augusta, Georgia Site Public Contact - (ga_cares@augusta.edu)
Beacon Kalamazoo Kalamazoo, Michigan
Beacon Kalamazoo Cancer Center Kalamazoo, Michigan
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)
Cambridge Medical Center Cambridge, Minnesota
Cancer Center of Western Wisconsin New Richmond, Wisconsin
Cancer and Blood Specialists-Henderson Henderson, Nevada Site Public Contact - (research@sncrf.org)
Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan Site Public Contact - (connie.szczepanek@crcwm.org)
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 Colorado Aurora, Colorado Site Public Contact - (josh.b.gordon@nsmtp.kp.org)
Children's Hospital and Medical Center of Omaha Omaha, Nebraska
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 the King's Daughters Norfolk, Virginia Site Public Contact - (CCBDCresearch@chkd.org)
Children's Mercy Hospitals and Clinics Kansas City, Missouri Site Public Contact - (rryan@cmh.edu)
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)
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)
Dell Children's Medical Center of Central Texas Austin, Texas Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org)
Desert West Surgery Las Vegas, Nevada
Duke University Medical Center Durham, North Carolina
El Paso Children's Hospital El Paso, Texas Site Public Contact - (ranjan.bista@ttuhsc.edu)
Emory University Hospital/Winship Cancer Institute Atlanta, Georgia
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
Fred Hutchinson Cancer Center Seattle, Washington
GenesisCare USA - Fort Apache Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
GenesisCare USA - Henderson Henderson, Nevada Site Public Contact - (research@sncrf.org)
GenesisCare USA - Las Vegas Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
GenesisCare USA - Vegas Tenaya Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Golisano Children's Hospital of Southwest Florida Fort Myers, Florida Site Public Contact - (molly.arnstrom@leehealth.org)
Gundersen Lutheran Medical Center La Crosse, Wisconsin
Health Partners Inc Minneapolis, Minnesota
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills Las Vegas, Nevada
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway Las Vegas, Nevada
HealthCare Partners Medical Group Oncology/Hematology-San Martin Las Vegas, Nevada
HealthCare Partners Medical Group Oncology/Hematology-Tenaya Las Vegas, Nevada
Hennepin County Medical Center Minneapolis, Minnesota
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)
Huntsman Cancer Institute/University of Utah Salt Lake City, Utah Site Public Contact - (cancerinfo@hci.utah.edu)
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)
Kingman Regional Medical Center Kingman, Arizona Site Public Contact - (research@sncrf.org)
LSU Health Baton Rouge-North Clinic Baton Rouge, Louisiana Site Public Contact - (research@ololrmc.com)
Lakeview Hospital Stillwater, Minnesota
Las Vegas Cancer Center-Henderson Henderson, Nevada
Las Vegas Cancer Center-Medical Center Las Vegas, Nevada
Las Vegas Prostate Cancer Center Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Las Vegas Urology - Cathedral Rock Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Las Vegas Urology - Green Valley Henderson, Nevada Site Public Contact - (research@sncrf.org)
Las Vegas Urology - Pebble Henderson, Nevada Site Public Contact - (research@sncrf.org)
Las Vegas Urology - Pecos Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Las Vegas Urology - Smoke Ranch Las Vegas, Nevada Site Public Contact - (research@smcrf.org)
Las Vegas Urology - Sunset Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Loma Linda University Medical Center Loma Linda, California
Loyola Center for Health at Burr Ridge Burr Ridge, Illinois
Loyola Medicine Homer Glen Homer Glen, Illinois
Loyola University Medical Center Maywood, Illinois
Lurie Children's Hospital-Chicago Chicago, Illinois
Marjorie Weinberg Cancer Center at Loyola-Gottlieb Melrose Park, Illinois
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
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida Site Public Contact - (OHR@mhs.net)
Mercy Hospital Coon Rapids, Minnesota
Methodist Children's Hospital of South Texas San Antonio, Texas Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com)
Minnesota Oncology - Burnsville Burnsville, Minnesota
Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota
Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota
Monticello Cancer Center Monticello, Minnesota
Munson Medical Center Traverse City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
New Ulm Medical Center New Ulm, Minnesota
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)
Northwestern Medicine Lake Forest Hospital Lake Forest, Illinois
Northwestern University Chicago, Illinois Site Public Contact - (cancer@northwestern.edu)
Norton Children's Hospital Louisville, Kentucky Site Public Contact - (CancerResource@nortonhealthcare.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
Our Lady of the Lake Physician Group Baton Rouge, Louisiana Site Public Contact - (research@ololrmc.com)
Overlake Medical Center Bellevue, Washington
PCR Oncology Arroyo Grande, California Site Public Contact - (research@sncrf.org)
Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota
Prisma Health Richland Hospital Columbia, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.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)
Regions Hospital Saint Paul, Minnesota
Renown Regional Medical Center Reno, Nevada Site Public Contact - (research@sncrf.org)
Rhode Island Hospital Providence, Rhode Island
Rice Memorial Hospital Willmar, Minnesota
Ridgeview Medical Center Waconia, Minnesota
Roswell Park Cancer Institute Buffalo, New York
Saint Francis Regional Medical Center Shakopee, Minnesota
Saint John's Hospital - Healtheast Maplewood, Minnesota
Saint Mary's Regional Medical Center Reno, Nevada Site Public Contact - (research@sncrf.org)
Southern Illinois University School of Medicine Springfield, Illinois
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)
The Children's Hospital at TriStar Centennial Nashville, Tennessee
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)
UC Comprehensive Cancer Center at Silver Cross New Lenox, Illinois
United Hospital Saint Paul, Minnesota
Unity Hospital Fridley, Minnesota
University Cancer Center Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
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 Chicago Comprehensive Cancer Center Chicago, Illinois
University of Chicago Medicine-Orland Park Orland Park, Illinois
University of Cincinnati Cancer Center-UC Medical Center Cincinnati, Ohio Site Public Contact - (cancer@uchealth.com)
University of Cincinnati Cancer Center-West Chester West Chester, Ohio
University of Illinois Chicago, Illinois
University of Michigan Health - West Wyoming, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota
University of Nebraska Medical Center Omaha, Nebraska Site Public Contact - (unmcrsa@unmc.edu)
University of New Mexico Cancer Center Albuquerque, New Mexico Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.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 Washington Medical Center - Montlake Seattle, Washington
Urology Specialists of Nevada - Central Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Urology Specialists of Nevada - Green Valley Henderson, Nevada Site Public Contact - (research@sncrf.org)
Urology Specialists of Nevada - Northwest Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Urology Specialists of Nevada - Southwest Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
Valley Medical Center Renton, Washington Site Public Contact - (research@valleymed.org)
Wayne State University/Karmanos Cancer Institute Detroit, Michigan
Weisberg Cancer Treatment Center Farmington Hills, Michigan
West Michigan Cancer Center Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
West Virginia University Healthcare Morgantown, West Virginia Site Public Contact - (cancertrialsinfo@hsc.wvu.edu)

EAP for subjects receiving Idecabtagene Vicleucel That is Nonconforming for Commercial Release

Hall, Charles, E. - hallce3@vcu.edu

Simmons, Gary, L.
N/A
NCT04771078
HM20021892
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Inclusion Criteria:

• Had a participant-specific batch of Idecabtagene vicleucel (ide-cel) manufactured intended for commercial treatment; however, the final manufactured product was nonconforming and did not meet commercial release criteria
• Remanufacturing is deemed not feasible or clinically inappropriate per assessment of the treating physician in discussion with the participant
• Clinically stable
Exclusion Criteria:

• Has a hypersensitivity to the active substance or to any of the excipients
• No experience of a significant worsening in clinical status that would, in the opinion of the treating physician, either increase the risk of Adverse Events associated with lymphodepleting chemotherapy, or exclude them from treatment with nonconforming Idecabtagene vicleucel (ide-cel)
• Has any condition and/or laboratory abnormality that places the participant at unacceptable risk if he/she were to participate in the Expanded Access Protocol based on the Investigator's judgement Other protocol-defined inclusion/exclusion criteria apply
Biological: Nonconforming idecabtagene vicleucel, drug: Idecabtagene vicleucel, Modality: Immunotherapy
Multiple Myeloma
BB2121, Multiple Myeloma, Expanded Access, idecabtagene vicleucel, nonconforming, CAR T, EAP, Pre-Approval Access
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Study Locations

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Location Contacts
Allegheny Health Network Pittsburgh, Pennsylvania
Avera McKennan Hospital & University Health Center Sioux Falls, South Dakota
Beth Israel Deaconess Medical Center Boston, Massachusetts
Boston Medical Center Boston, Massachusetts
Cancer Center Of Kansas Wichita, Kansas
Cancer Treatment Centers of America, Chicago Zion, Illinois
Cedars-Sinai Medical Center Los Angeles, California
City of Hope cancer Center Duarte, California
Cleveland Clinic Cleveland, Ohio
Colorado Blood Cancer Institute Denver, Colorado
Columbia-Presbyterian Medical Center New York, New York
Dana Farber Cancer Institute Boston, Massachusetts
Fox Chase Cancer Center Philadelphia, Pennsylvania
Fred Hutchinson Cancer Research Center Seattle, Washington
Froedtert Hospital BMT Medical College of Wisconsin Milwaukee, Wisconsin
Greenville Health System Greenville, South Carolina
H Lee Moffitt Cancer Center Tampa, Florida
Hackensack University Medical Center Hackensack, New Jersey
Henry Ford Hospital Detroit, Michigan
Indiana University Cancer Center Indianapolis, Indiana
Intermountain Healthcare - LDS Hospital Salt Lake City, Utah
Karmanos Cancer Institute Detroit, Michigan
Massachusetts General Hospital / Dana-Farber Cancer Institute Boston, Massachusetts
Mayo Clinic Rochester, Minnesota
Mayo Clinic - Jacksonville Jacksonville, Florida
MedStar Georgetown University Hospital Washington D.C., District of Columbia
Medical City Dallas Hospital Dallas, Texas
Medical University of South Carolina Hollings Cancer Center Charleston, South Carolina
Memorial Sloan Kettering Cancer Center New York, New York
Methodist Hospital - Texas Transplant Institute San Antonio, Texas
Mount Sinai Hospital New York, New York
New York Presbyterian Cornell University New York, New York
Northside Hospital, Inc Atlanta, Georgia
Ohio State University Wexner Medical Center Columbus, Ohio
Oregon Health and Science University OHSU Portland, Oregon
Providence Portland Medical Center Portland, Oregon
Robert H. Lurie Comprehensive Cancer Center Chicago, Illinois
Roswell Park Cancer Institute Buffalo, New York
Rush University Medical Center Chicago, Illinois
Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey
Sarah Cannon Research Institute Nashville, Tennessee
Spectrum Health Grand Rapids, Michigan
St. David's South Austin Medical Center Austin, Texas
Stanford University Palo Alto, California
Texas Medical Center Houston, Texas
Texas Oncology - Baylor Charles A. Sammons Cancer Center Dallas, Texas
The University of Texas - MD Anderson Cancer Center Houston, Texas
Thomas Jefferson University Philadelphia, Pennsylvania
UCLA School of Medicine Los Angeles, California
UT Southwestern Medical Center Simmons Comprehensive Cancer Center Dallas, Texas
Univ of AR for Medical Sciences Little Rock, Arkansas
University Hospitals Cleveland Medical Center Cleveland, Ohio
University of Alabama Birmingham, Alabama
University of California San Diego Moores Cancer Center La Jolla, California
University of California San Francisco Medical Center San Francisco, California
University of Chicago Chicago, Illinois
University of Cincinnati Cincinnati, Ohio
University of Illinois Medical Center Chicago, Illinois
University of Iowa Hospitals and Clinics Iowa City, Iowa
University of Kansas Medical Center Kansas City, Kansas
University of Kentucky Lexington, Kentucky
University of Maryland - Greenebaum Comprehensive Cancer Center Baltimore, Maryland
University of Massachusetts Worcester, Massachusetts
University of Miami Sylvester Cancer Center Miami, Florida
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan
University of Nebraska Medical Center Omaha, Nebraska
University of North Carolina at Chapel Hill Chapel Hill, North Carolina
University of Pennsylvania Philadelphia, Pennsylvania
University of Utah - Huntsman Cancer Institute Salt Lake City, Utah
University of Virginia Charlottesville, Virginia
VCU Massey Cancer Center Richmond, Virginia
Virginia Commonwealth University Richmond, Virginia Hall, Charles, E. - (hallce3@vcu.edu)
Washington Univ School of Medicine Siteman Cancer Center Saint Louis, Missouri
West Virginia University - Berkeley Medical Center - Cancer and Infusion Center Morgantown, West Virginia
Winship Cancer Institute of Emory University Atlanta, Georgia
Yale Cancer Center New Haven, Connecticut

A Phase 1B/2 Study of RP1 in Solid Organ Transplant Patients With Advanced Cutaneous Malignancies (ARTACUS)

Clinical Trials at Replimune - Clinicaltrials@replimune.com

Poklepovic, Andrew, S
PHASE1
NCT04349436
HM20021229
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Key
Inclusion Criteria:

• Voluntary agreement to provide written informed consent prior to any study procedures and the willingness and ability to comply with all aspects of the protocol and understand the risk to their organ allograft.
• Patients with histologically or cytologically confirmed recurrent, locally advanced or metastatic (to skin, soft tissue or lymph nodes) cutaneous malignancies, including CSCC, basal cell carcinoma, Merkel cell carcinoma, and melanoma
• Patients must have progressed following local resection, prior radiation, topical or systemic therapies.
• Documentation from the patient's transplant physician confirming that the patient's allograft is stable.
• Patients for whom surgical or radiation treatment of lesions is contraindicated.
• At least 1 lesion that is measurable and injectable by study criteria (tumor of ≥1cm in longest diameter or ≥1.5 cm in shortest diameter for lymph nodes).
• Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
• Anticipated life expectancy \> 6 months
• Baseline ECG without evidence of acute ischemia.
• All patients must consent to provide archived or newly obtained tumor material (either formalin-fixed, paraffin-embedded \[FFPE\] block or 20 unstained slides). Key
Exclusion Criteria:

• Prior treatment with an oncolytic therapy.
• Patients with visceral metastases.
• Patients with active herpetic infections or prior complications of HSV-1 infection (e.g., herpetic keratitis or encephalitis).
• Patients with a history of organ graft rejection within 12 months.
• Had systemic infection requiring intravenous (IV) antibiotics or anti-virals, or other serious infection within 60 days prior to dosing.
• Patients who require intermittent or chronic use of systemic (oral or intravenous) anti-virals with known anti-herpetic activity (e.g., acyclovir) unless for organ allograft preservation.
• Patients requiring CTLA-4-Ig medications.
• Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments beyond that required for maintenance allograft rejection prevention. The following are not exclusionary: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism that requires only hormone replacement, or psoriasis that does not require systemic treatment.
• Active infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
• Any history of transplant-related viral infections, such as BKV, EBV or CMV, within 3 months of study entry. Patients with a history of hepatitis B or C virus must have undetectable viral load within 3 months of study entry.
• Patients with a condition requiring an increase in the patient's usual immunosuppressive medications within 60 days of study treatment.
• Known active CNS metastases and/or carcinomatous meningitis.
BIOLOGICAL: RP1, intra-tumoral injection, oncolytic virus
Cutaneous Squamous Cell Carcinoma, Merkel Cell Carcinoma, Basal Cell Carcinoma, Melanoma
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Study Locations

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Location Contacts
Columbia University Medical Center New York, New York
Dana Farber Cancer Institute Boston, Massachusetts
Duke University Durham, North Carolina
Inova Schar Cancer Institute Fairfax, Virginia
MD Anderson Cancer Center Houston, Texas
Mayo Clinic Arizona Phoenix, Arizona
Mayo Clinic Florida Jacksonville, Florida
Mayo Clinic Rochester Rochester, Minnesota
Medical Dermatology Specialists Phoenix, Arizona
Moffitt Cancer Center Tampa, Florida
Oregon Health and Science University Portland, Oregon
Rochester Dermatologic Surgery New York, New York
The Cleveland Clinic Foundation Cleveland, Ohio
The Ohio State University Comprehensive Cancer Center Columbus, Ohio
UCSF, Helen Diller Family Comprehensive Cancer Center San Francisco, California
University of California, Los Angeles Los Angeles, California
University of California, San Diego La Jolla, California
University of Chicago Chicago, Illinois
University of Cincinnati Cincinnati, Ohio
University of Colorado Cancer Center School of Medicine Aurora, Colorado
University of Miami Sylvester Comprehensive Cancer Center Miami, Florida
University of Michigan Ann Arbor, Michigan
University of North Carolina Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina
University of Pittsburgh Medical Center Pittsburgh, Pennsylvania
University of Tennessee Medical Center at Knoxville Knoxville, Tennessee
University of Texas Southwestern Dallas, Texas
VCU Massey Cancer Center Richmond, Virginia
Washington University in St. Louis St Louis, Missouri

Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (ICECAP)

William Meurer - wmeurer@med.umich.edu

Peberdy, Mary Ann
NA
NCT04217551
HM20019809
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Inclusion Criteria:
* Coma after resuscitation from out of hospital cardiac arrest * Cooled to \<34 deg C with 240 minutes of cardiac arrest * Definitive temperature control applied * Age ≥ 18 years * Informed consent from legal authorized representative (LAR) including intent to maintain life support for 96 hours * Enrollment within 6 hours of initiation of cooling
Exclusion Criteria:
* Hemodynamic instability * Pre-existing neurological disability or condition that confounds outcome determination * Pre-existing terminal illness, unlikely to survive to outcome determination * Planned early withdrawal of life support * Presumed sepsis as etiology of arrest * Prisoner
DEVICE: Therapeutic Hypothermia
Cardiac Arrest, Out-Of-Hospital, Hypothermia, Induced, Hypoxia-Ischemia, Brain
Bayesian Adaptive Clinical Trial, Hypothermia, therapeutic, Coma
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Study Locations

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Location Contacts
Adventist Health Portland, Oregon
Advocate Christ Medical Center Oak Lawn, Illinois
Banner University Medical Center Phoenix, Arizona
Beth Israel Deaconess Medical Center Boston, Massachusetts
Brigham & Women's Hospital Boston, Massachusetts
Cedars-Sinai Medical Center Los Angeles, California
Cooper University Hospital Camden, New Jersey
DMC Sinai Grace Hospital Detroit, Michigan
Denver Health Medical Center Denver, Colorado
Detroit Receiving Hospital Detroit, Michigan
Duke University Hospital Durham, North Carolina
ECU Health Medical Center Greenville, North Carolina
Froedtert Hospital Milwaukee, Wisconsin
Geisinger Medical Center Danville, Pennsylvania
Grady Memorial Hospital Atlanta, Georgia
Guthrie Robert Packer Hospital Sayre, Pennsylvania
Harbor-UCLA Medical Center Torrance, California
Harborview Medical Center Seattle, Washington
Hennepin County Medical Center Minneapolis, Minnesota
Henry Ford Hospital Detroit, Michigan
Henry Ford Macomb Hospital Clinton Township, Michigan
Hospital of the University of Pennsylvania Philadelphia, Pennsylvania
IU Health Methodist Hospital Indianapolis, Indiana
Johns Hopkins Hospital Baltimore, Maryland
Kings County Hospital Center Brooklyn, New York
M Health Fairview East Bank Hospital Minneapolis, Minnesota
M Health Fairview Southdale Hospital Edina, Minnesota
Maine Medical Center Portland, Maine
Massachusetts General Hospital Boston, Massachusetts
Memorial Hermann Hospital Houston, Texas
Mercy St. Vincent Medical Center Toledo, Ohio
Montefiore Medical Center The Bronx, New York
NYP Columbia University Medical Center New York, New York
NYU Langone Health - Tisch Hospital New York, New York
Northwestern Memorial Hospital Chicago, Illinois
OSU East Hospital Columbus, Ohio
OSU Wexner Medical Center Columbus, Ohio
Parkland Hospital Dallas, Texas
Penn Presbyterian Medical Center Philadelphia, Pennsylvania
Providence Regional Medical Center Everett Everett, Washington
Regions Hospital Saint Paul, Minnesota
Ronald Regan UCLA Medical Center Los Angeles, California
Rush University Medical Center Chicago, Illinois
SUNY Upstate Medical University Syracuse, New York
South Shore University Hospital Bay Shore, New York
Spectrum Health Butterworth Hospital Grand Rapids, Michigan
Stanford University Medical Center Palo Alto, California
Stony Brook University Hospital Stony Brook, New York
Strong Memorial Hospital Rochester, New York
Temple University Hospital Philadelphia, Pennsylvania
The Mount Sinai Hospital New York, New York
The Queen's Medical Center Honolulu, Hawaii
Thomas Jefferson University Hospital Philadelphia, Pennsylvania
UC Davis Medical Center Sacramento, California
UC San Diego Medical Center - Hillcrest San Diego, California
UF Health Shands Hospital Gainesville, Florida
UPMC Harrisburg Mechanicsburg, Pennsylvania
University of Alabama Hospital Birmingham, Alabama
University of Chicago Medical Center Chicago, Illinois
University of Cincinnati Cincinnati, Ohio
University of Colorado Hospital Aurora, Colorado
University of Illinois-Chicago Hosptial Chicago, Illinois
University of Kansas Medical Center Kansas City, Kansas
University of Kentucky Hospital Lexington, Kentucky
University of Maryland Medical Center Baltimore, Maryland
University of Michigan Hospital Ann Arbor, Michigan
University of Nebraska Medical Center Omaha, Nebraska
University of New Mexico Albuquerque, New Mexico
University of Pittsburgh Medical Center Pittsburgh, Pennsylvania
University of Utah Hospital Salt Lake City, Utah
University of Virginia Medical Center Charlottesville, Virginia
UofL Health - Jewish Hospital Louisville, Kentucky
VCU Medical Center Richmond, Virginia
Wake Forest Baptist Medical Center Winston-Salem, North Carolina
William Beaumont Hospital Royal Oak, Michigan
Yale New Haven Hospital New Haven, Connecticut
Zuckerberg San Francisco General Hospital San Francisco, California

Mindful Moms Randomized Control Trial

Patricia Kinser, PhD - kinserpa@vcu.edu

Kinser, Patricia, A
NA
NCT04886856
HM20021720
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Inclusion Criteria:

• pregnant woman at 12-26 weeks gestation at baseline visit;
• defined as minority (e.g., Black/ African American, Hispanic/ Latino, Native American, etc) and/or annual household income at qualification level for Women, Infants, \& Children \[WIC\] benefits in Virginia and/or educational attainment ≤high school education;
• ≥age 18;
• current depressive symptoms, as defined by a score ≥7 on the Edinburgh Postnatal Depression Scale (EPDS);
• able to read, write, and understand English;
• has not been told by a healthcare provider to avoid physical activity;
• has not engaged in a consistent (once/week or more) yoga-based practice during the current pregnancy.
Exclusion Criteria:
Does not meet the inclusion criteria above.
BEHAVIORAL: Mindful Moms, BEHAVIORAL: Prenatal Education
Depression
pregnancy
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Virginia Commonwealth University Richmond, Virginia

Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer (AIM-NIVO)

McFadden, Faith - mcfaddenfr@vcu.edu

Poklepovic, Andrew, S
PHASE1
NCT03816345
HM20022009
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Inclusion Criteria:
* Patients can have either histologically confirmed malignancy that is radiologically evaluable and metastatic or unresectable, or have a malignancy for which a PD-1/PD-L1 inhibitor has been approved in the adjuvant setting. Eligible tumor types include solid tumors and malignancies in which there is known evidence of clinical activity for single agent PD-1 or PD-L1 antibodies. Nivolumab is Food and Drug Administration (FDA)-approved for the treatment of melanoma, non-small cell lung cancer (NSCLC), Merkel cell cancer, bladder cancer, renal cell carcinoma (RCC), gastric cancer, hepatocellular carcinoma (HCC), cervical cancer, head and neck cancer, Hodgkin lymphoma (HL), metastatic small cell lung cancer (SCLC), and any solid tumor with microsatellite instability (MSI)-high status confirmed. Patients with HL are eligible but must follow standard response criteria. Additional tumor types may be eligible on a case by case basis upon discussion with principal investigator (PI). Patients enrolling on the trial for adjuvant use will be restricted to those with histology for which a PD-1/PD-L1 inhibitor has been approved in the adjuvant setting including but not limited to NSCLC, melanoma, RCC, cervical cancer, and bladder cancer * Patients who have previously received other forms of immunotherapy (high-dose \[HD\] IL-2, IFN, CTLA-4) are allowed. Patients must not have received cytokine immunotherapy for at least 4 weeks before nivolumab administration. Patients who have received prior anti-CTLA4 will be allowed and the washout period is 6 weeks * Age \>= 18 years; children are excluded from this study but may be eligible for future pediatric phase 1 combination trials * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Karnofsky \>= 60) * Life expectancy of greater than 12 weeks * Leukocytes \>= 1,000/mcL * Absolute neutrophil count \>= 500/mcL * Platelets \>= 50,000/mcL * Total bilirubin =\< 2 x institutional upper limit of normal (ULN) * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 5 x institutional ULN or =\< 8 x institutional ULN for patients with liver metastases or an autoimmune disease that is contributing to the elevation of these values * Creatinine ULN OR glomerular filtration rate (GFR) \>= 30 mL/min (if using the Cockcroft-Gault formula) * Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial * If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable on suppressive therapy if indicated * If history of hepatitis C virus (HCV) infection, must be treated with undetectable HCV viral load * Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate central nervous system (CNS) specific treatment is not required and is unlikely to be required for at least 4 weeks (or scheduled assessment after the first cycle of treatment), and a risk-benefit analysis (discussion) by the patient and the investigator favors participation in the clinical trial * The effects of nivolumab on the developing human fetus are unknown. For this reason, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 5 months after the last dose of investigational product. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational product. Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]) within 24 hours prior to the start of nivolumab. Women must not be breastfeeding. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL. These durations have been calculated using the upper limit of the half-life for nivolumab (25 days) and are based on the protocol requirement that WOCBP use contraception for 5 half-lives plus 30 days, and men who are sexually active with WOCBP use contraception for 5 half-lives plus 90 days. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately * Ability to understand and the willingness to sign a written informed consent document * Patients with more than one autoimmune disease are eligible. The treating physician would determine which autoimmune disease is dominant and the patient would be treated under that specific cohort
Exclusion Criteria:
* Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (AEs) due to agents administered more than 4 weeks earlier have not resolved or stabilized. Palliative (limited-field) radiation therapy (RT) is permitted (2 week washout from start of treatment), if all of the following criteria are met: * Repeat imaging demonstrates no new sites of bone metastases * The lesion being considered for palliative radiation is not a target lesion * Patients with prior therapy with an anti-PD-1 or anti-PD-L1 * Patients with prior allogeneic hematologic transplant * Patients who are receiving any other anticancer investigational agents * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
PROCEDURE: Biospecimen Collection, BIOLOGICAL: Nivolumab
Autoimmune Disease, Crohn Disease, Dermatomyositis, Hematopoietic and Lymphoid Cell Neoplasm, Inflammatory Bowel Disease, Malignant Solid Neoplasm, Multiple Sclerosis, Psoriasis, Psoriatic Arthritis, Rheumatoid Arthritis, Sjogren Syndrome, Systemic Lupus Erythematosus, Systemic Scleroderma, Ulcerative Colitis
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Study Locations

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Dana-Farber Cancer Institute Boston, Massachusetts
Emory University Hospital/Winship Cancer Institute Atlanta, Georgia
HaysMed Hays, Kansas
Huntsman Cancer Institute/University of Utah Salt Lake City, Utah
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland Site Public Contact - (jhcccro@jhmi.edu)
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York Site Public Contact - (CancerTrials@nyulangone.org)
Lawrence Memorial Hospital Lawrence, Kansas Site Public Contact - (Stephanie.Norris@LMH.ORG)
M D Anderson Cancer Center Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
Massachusetts General Hospital Cancer Center Boston, Massachusetts
MedStar Georgetown University Hospital Washington D.C., District of Columbia
Mercy Hospital Pittsburg Pittsburg, Kansas
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)
National Cancer Institute Developmental Therapeutics Clinic Bethesda, Maryland
National Institutes of Health Clinical Center Bethesda, Maryland
Northwestern University Chicago, Illinois
Ohio State University Comprehensive Cancer Center Columbus, Ohio Site Public Contact - (Jamesline@osumc.edu)
Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey
Salina Regional Health Center Salina, Kansas Site Public Contact - (mleepers@srhc.com)
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)
Smilow Cancer Center/Yale-New Haven Hospital New Haven, Connecticut Site Public Contact - (canceranswers@yale.edu)
Stanford Cancer Institute Palo Alto Palo Alto, California
The University of Kansas Cancer Center - Olathe Olathe, Kansas Site Public Contact - (OlatheCCResearch@kumc.edu)
Thomas Jefferson University Hospital Philadelphia, Pennsylvania
UT Southwestern Clinical Center at Richardson/Plano Richardson, Texas Site Public Contact - (Suzanne.cole@utsouthwestern.edu)
UT Southwestern Simmons Cancer Center - RedBird Dallas, Texas Site Public Contact - (canceranswerline@utsouthwestern.edu)
UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas Site Public Contact - (canceranswerline@UTSouthwestern.edu)
UT Southwestern/Simmons Cancer Center-Fort Worth Fort Worth, Texas Site Public Contact - (canceranswerline@UTSouthwestern.edu)
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
University of California Davis Comprehensive Cancer Center Sacramento, California
University of Chicago Comprehensive Cancer Center Chicago, Illinois
University of Kansas Cancer Center Kansas City, Kansas Site Public Contact - (KUCC_Navigation@kumc.edu)
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 at North Kansas City Hospital 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 Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
Washington University School of Medicine St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
Wayne State University/Karmanos Cancer Institute Detroit, Michigan
Yale University New Haven, Connecticut Site Public Contact - (canceranswers@yale.edu)

Nonconforming Lisocabtagene Maraleucel Expanded Access Protocol

Hall, Charles, E. - hallce3@vcu.edu

Simmons, Gary, L.
N/A
NCT04400591
HM20022052
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Inclusion Criteria:

• Subject and/or LAR must understand and voluntarily sign an informed consent form prior to any study-related assessments/procedures being conducted.
• Subject has relapsed and/or refractory large B-cell lymphoma and is, per the treating physician assessment, eligible for treatment with lisocabtagene maraleucel per the approved prescribing information.
• Subject is ? 18 years of age at the time of signing the informed consent form.
• Subject had a specific batch of lisocabtagene maraleucel manufactured intended for commercial treatment; however, the final manufactured product did not meet commercial release criteria.
• Remanufacturing (eg, repeat leukapheresis and manufacturing) is deemed not feasible or clinically inappropriate per assessment of the treating physician in discussion with the subject.
• Subject is clinically stable, has recovered from any toxicities prior to receiving lymphodepleting chemotherapy, and has adequate bone marrow function to receive lymphodepleting chemotherapy. The treating physician is advised to contact Medical Monitor in the event there is any concern regarding administration of lymphodepleting chemotherapy.
• Females of childbearing potential must:
• Have a negative pregnancy test as verified by the treating physician within 7 days prior to the first dose of lymphodepleting chemotherapy following institutional testing methodology practices. This applies even if the subject practices true abstinence from heterosexual contact.
• Either commit to true abstinence from heterosexual contact or agree to use, and be able to comply with, effective contraception without interruption. Contraception methods must include 1 highly effective method from screening until at least 12 months after the nonconforming lisocabtagene maraleucel administration.
• Agree to abstain from breastfeeding during study participation and for at least 12 months following nonconforming lisocabtagene maraleucel administration.
• There are insufficient exposure data to provide any recommendation concerning the duration of contraception and the abstaining from breastfeeding following treatment with lisocabtagene maraleucel. Any decision regarding contraception and breastfeeding after infusion should be discussed with the treating physician.
• Male subjects must:
• Practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential for at least 12 months after nonconforming lisocabtagene maraleucel administration even if the subject has undergone a successful vasectomy.
• There are insufficient exposure data to provide any recommendation concerning the duration of contraception following treatment with lisocabtagene maraleucel. Any decision regarding contraception after infusion should be discussed with the treating physician
• Subject must agree to not donate blood, organs, tissue, sperm or semen and egg cells for usage in other individuals for at least 1 year following nonconforming lisocabtagene maraleucel administration.
Exclusion Criteria:

• Subject has a hypersensitivity to the active substance or to any of the excipients.
• Subject should not experience a significant worsening in clinical status that would, in the opinion of the treating physician, either increase the risk of adverse events associated with lymphodepleting chemotherapy, or exclude them from treatment with nonconforming lisocabtagene maraleucel.
• Subject has any significant medical condition, laboratory abnormality, or psychiatric illness, sociologic or geographic condition that would prevent the subject from participating in the Expanded Access Protocol complying with protocol requirements in the Investigator's judgement.
• Subject has any condition and/or laboratory abnormality that places the subject at unacceptable risk if he/she were to participate in the Expanded Access Protocol based on the Investigator's judgement
• Pregnant or nursing women or has intention of becoming pregnant during the study.
• Subjects with central nervous system (CNS)-only involvement by malignancy (note: subjects with secondary CNS involvement are allowed on study).
• Subject has active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection at the time of pretreatment evaluation
• Subject has uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment at the time of nonconforming lisocabtagene maraleucel administration.
• Subject has presence of acute or chronic graft-versus-host disease (ie, GVHD)
• Use of the following:
• Therapeutic doses of corticosteroids (defined as > 20 mg/day prednisone or equivalent) within 72 hours prior to nonconforming lisocabtagene maraleucel administration. Physiologic replacement, topical, and inhaled steroids are permitted.
• Low dose chemotherapy (eg, vincristine, rituximab, cyclophosphamide ? 300 mg/m2)given after leukapheresis to maintain disease control must be stopped ? 7 days prior to lymphodepleting chemotherapy.
• Cytotoxic chemotherapeutic agents that are not considered lymphotoxic (see below) within 1 week of LD chemotherapy. Oral chemotherapeutic agents, including lenalidomide and ibrutinib, are allowed if at least 3 half-lives have elapsed prior to lymphodepleting chemotherapy.
• Donor lymphocyte infusions within 6 weeks of nonconforming lisocabtagene maraleucel administration.
Biological: Nonconforming Lisocabtagene Maraleucel
Lymphoma, Large B-Cell, Diffuse
Expanded Access, JCAR017, Lisocabtagene Maraleucel, CAR T, nonconforming,, relapsed/refractory diffuse large B cell lymphoma, nonconforming lisocabtagene mareleucel
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Allegheny Health Network Pittsburgh, Pennsylvania
Avera Cancer Institute Sioux Falls, South Dakota
Baylor University Medical Center Dallas, Texas
Beth Israel Deaconess Medical Center Boston, Massachusetts
Cancer Center Of Kansas Wichita, Kansas
Cancer Centre of Excellence - Univ of MA Medical School Worcester, Massachusetts
Cancer Treatment Centers of America, Chicago Zion, Illinois
Cedars-Sinai Medical Center Los Angeles, California
Chiba University Hospital Chiba, Chiba
City of Hope Duarte, California
Cleveland Clinic - Taussig Cancer Institute Cleveland, Ohio
Colorado Blood Cancer Institute Denver, Colorado
Fox Chase Cancer Center Philadelphia, Pennsylvania
Fred Hutchinson Cancer Research Center Seattle, Washington
Froedtert Hospital BMT Medical College of Wisconsin Milwaukee, Wisconsin
Georgetown University Hospital Washington, District of Columbia
Hackensack University Medical Center Hackensack, New Jersey
Henry Ford Health System Division of Hematology Oncology Detroit, Michigan
Hokkaido University Hospital Sapporo, Hokkaido
HonorHealth Research Institute Scottsdale, Arizona
Houston Methodist Hospital Houston, Texas
Hyogo College of Medicine Hospital Hyōgo,
Intermountain Healthcare - LDS Hospital Salt Lake City, Utah
Jichi Medical University Hospital Tochigi,
Kanazawa University Hospital Kanazawa,
Karmanos Cancer Institute Detroit, Michigan
Keio University Hospital Shinjuku-ku, Tokyo
Kindai University Hospital Osakasayama-shi, Osaka
Kumamoto University Hospital Kumamoto,
Kyoto University Hospital Kyoto,
Kyushu University Hospital Fukuoka,
Levine Cancer Institute Charlotte, North Carolina
Massachusetts General Hospital Boston, Massachusetts
Mayo Clinic - Jacksonville Jacksonville, Florida
Mayo Clinic Cancer Center Jacksonville, Florida
Medical City Dallas Hospital Dallas, Texas
Memorial Sloan Kettering Cancer Center New York, New York
Methodist Hospital - Texas Transplant Institute San Antonio, Texas
Moffit Cancer Center Tampa, Florida
Mount Sinai Hospital New York, New York
National Cancer Center Hospital Tokyo,
New York Oncology Hematology P.C. Albany, New York
New York Presbyterian Hospital Weill Medical College Cornell University New York, New York
Northwestern University Medical Center Chicago, Illinois
Okayama University Hospital Okayama, Okayama-ken
Oregon Health and Science University Portland, Oregon
Osaka City University Hospital Osaka,
Osaka University Hospital OUH Osaka-Fu,
Prisma Health System - Eastside Cancer Center Greenville, South Carolina
Roswell Park Cancer Center Buffalo, New York
Rush University Medical Center Chicago, Illinois
Sarah Cannon Research Institute Nashville, Tennessee
Spectrum Health Grand Rapids, Michigan
Swedish Cancer Institute Seattle, Washington
The Ohio State University Comprehensive Cancer Center Columbus, Ohio
The University of Texas - MD Anderson Cancer Center Houston, Texas
Tohoku University Hospital Miyagi,
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Bunkyō City,
UT Southwestern Medical Center Dallas, Texas
University Hospitals Case Medical Center Cleveland, Ohio
University of Alabama at Birmingham Hospital Birmingham, Alabama
University of California San Francisco Medical Center San Francisco, California
University of Cincinnati Medical Center Cincinnati, Ohio
University of Colorado Denver, Colorado
University of Iowa Hospitals and Clinics Iowa City, Iowa
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan
University of Nebraska Medical Center Omaha, Nebraska
University of North Carolina Chapel Hill, North Carolina
University of Oklahoma Peggy and Charles Stephenson Cancer Center Oklahoma City, Oklahoma
University of Pittsburgh Medical Center Hillman Cancer Center Pittsburgh, Pennsylvania
University of Rochester Rochester, New York
VCU Massey Cancer Center Richmond, Virginia
Virginia Commonwealth University Richmond, Virginia Hall, Charles, E. - (hallce3@vcu.edu)
West Virginia University - Berkeley Medical Center - Cancer and Infusion Center Morgantown, West Virginia
Winship Cancer Institute of Emory University Atlanta, Georgia
Yale University School of Medicine New Haven, Connecticut

Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery (FLORA-5)

Clinical Operations - ClinicalTrialDisclosures@oncoquestinc.com

Randall, Leslie
Phase 3
NCT04498117
HM20021341
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Major
Inclusion Criteria:

• Adults 18 years old or older.
• Newly diagnosed epithelial adenocarcinoma of ovarian, fallopian tube or peritoneal origin FIGO Stage III or IV disease.
• Histologic epithelial cell types: high grade serous adenocarcinoma, high grade endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).
• Completed debulking surgery (either primary debulking surgery or interval debulking surgery at the discretion of the investigator). Debulking surgery must be optimal, R1 or R0 (defined as R1, macroscopic no greater than 1 cm in diameter, or R0, microscopic or no evidence of tumor).
• Preoperative serum CA- 125 levels ≥ 50 U/mL.
• Adequate bone marrow function:
• Absolute neutrophil count (ANC) greater than or equal to 1,500/µL
• Platelets greater than or equal to100,000/µL
• Hemoglobin greater than or equal to 8.0 g/dL (Note: Blood transfusion is permitted up to 48 hours before first dose of study treatment).
• Adequate liver function:
• Bilirubin < 1.5 times upper limit normal (ULN)
• Lactate Dehydrogenase (LDH), SGOT/AST and SGPT/ALT < 2.5 times ULN
• Albumin >3.5 g/dL
• Adequate renal function: a. Creatinine less than or equal to1.5 times ULN
• ECOG Performance Status of 0 or 1. Major
Exclusion Criteria:

• BRCA1 or BRCA2 germline gene mutation test result with:
• Positive, ambiguous or inconclusive result available within 28 days prior to starting study treatment, or
• Known BRCA1 and BRCA2 somatic mutations, and known positive germline, or
• Somatic Homologous Recombination Deficiency (HRD) who will receive PARP inhibitor front-line maintenance therapy.
• Subjects with mucinous adenocarcinoma and low- grade adenocarcinoma.
• Female subjects who are lactating and breastfeeding, or have a positive serum pregnancy test within 7 days prior to the first dose of study treatment (C1D1 for Cohort 1 or C4D1 for Cohort 2).
• Active autoimmune disease, such as rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS), or ankylosing spondylitis requiring active disease modifying treatment.
• Known allergy to murine proteins or hypersensitivity to any of the excipients of the oregovomab, paclitaxel, or carboplatin.
• Chronically treated with immunosuppressive drugs such as cyclosporine, adrenocorticotropic hormone (ACTH), etc. (see Appendix G).
• Chronic therapeutic corticosteroid use, defined as > 5 days of prednisone or equivalent, with the exception of inhalers or those on a pre-planned steroid taper. (Note: Premedication with corticosteroids per institutional standard of care is allowed.)
• Recognized acquired, hereditary, or congenital immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia.
• Anticipated treatment with any other anti-cancer medications, including bevacizumab, poly (ADP- ribose) polymerase (PARP) inhibitors, or any investigational agent(s) during the study.
Biological: Oregovomab, Drug: Paclitaxel, Drug: Carboplatin, Biological: Placebo
Carcinoma, Ovarian Epithelial, Ovarian Neoplasms, Ovarian Cancer, Ovarian Serous Adenocarcinoma, Fallopian Tube Neoplasms, Fallopian Tube Adenocarcinoma, Fallopian Tube Serous Adenocarcinoma, Peritoneal Cancer, Peritoneal Carcinoma, Peritoneal Neoplasms
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Study Locations

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Location Contacts
AZ Sint-Jan Bruges, Eveline De Cuypere, MD
AdventHealth Orlando Orlando, Florida Robert Holloway, MD
All India Institute of Medical Services Delhi, Sachin Khurana, MD
Asan Medical Center Seoul, Yong-Man Kim
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo) Monza, Andrea Alberto Lissoni, MD
Bacs-Kiskun Megyei Oktatokorhaz Kecskemét, Other Zsolt Horvath
Baylor Scott & White Health Temple, Texas
CEMAIC - Centro Medico Privado Córdoba, Cordoba Jorge Emilio Salinas, MD
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia Santo André, SP Patricia Santi
CER San Juan Centro Polivalente de Asistencia e Inv. Clinica San Juan, Juan Manuel Puig, MD
CHUM Centre de Recherche (affiliated with University of Montreal) Montréal, Quebec Diane Provencher, MD, FRCSC
CHUS - Hôpital Fleurimont Sherbrooke, Quebec Paul Bessette, MD
Carilion Clinic Gynecological Oncology Roanoke, Virginia David A Iglesias, MD
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital Mae de Deus Porto Alegre, Christina Pimentel Oppermann
Centro Potosino de Investigación Medica S.C. San Luis Potosi, Dolores Leticia Mendoza Oliva
Centro de Estudios Clínicos e Investigación Médica (CeCim) Santiago, Carla Saavedra, MD
Centro de Investigación Clínica Bradford Hill Santiago, Carlos Rojas
Centro de Pesquisa Clinica e Oncologia Guimaraes, Rodrigo Fabio Andre Franke, MD
Centro de Pesquisas Clinica Reichow Blumenau, Sandro Laercio Reichow
China Medical University Hospital Taichung, Lian-Shung Yeh, MD
City of Health Hospital at Laval (Cité de la Santé de Laval) Laval, Quebec Melanie Arbour-Levert, MD
Cleveland Clinic Cleveland, Ohio Steven Waggoner, MD
Cleveland Clinic Fairview Hospital Cleveland, Ohio Steven Waggoner, MD
Cleveland Clinic Hillcrest Hospital Mayfield Heights, Ohio Steven Waggoner
Clinical Medical Research S.C. Orizaba, Veracruz Jose David Gomez Rangel
Clinicas Viedma S.A. Viedma, Ruben Kowalyszyn
Clinique CHC MontLégia Liège, Maryam Bourhaba
Cliniques Universitaires Saint-Luc Brussels, Jean-François Baurain
Clínica São Germano - Oncologia Sao Paulo, Augusto Takao Rodrigues Pereira
Clínica Universitaria Privada Reina Fabiola Córdoba, Cordoba Santiago Bella, MD
Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda. Sao Paulo, Andre Mattar
Contra Costa Oncology Walnut Creek, California Babak Edraki, MD
Debreceni Egyetem Debrecen, Krasznai Zoard
Deenanath Mangeshkar Hospital Pune, Chetan Dilip Deshmukh, MD
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet Budapest, Gyorgy Bodoky
Diablo Valley Oncology Hematology Medical Group Pleasant Hill, California Babak Edraki, MD
Duke University Durham, North Carolina Angeles Alvarez Secord, MD
Duke Women's Cancer Care Raleigh Raleigh, North Carolina Angeles Alvarez Secord, MD
Epic Care Pleasant Hill, California Babak Edraki, MD
Fakultni nemocnice Bulovka Prague, Michael Zikan
Fakultni nemocnice Hradec Kralove Hradec Králové, Jiri Spacek, MD, PhD
Fakultni nemocnice Kralovske Vinohrady Prague, Lukas Rob
Fakultni nemocnice Olomouc Olomouc, Bohuslav Melichar
Fakultni nemocnice v Motole Prague, Jana Prausova, MUDr
Fondazione Policlinico Universitario Agostino Gemelli Irccs Roma, Giovanni Scambia
Fortis Hospital Ltd Bengaluru, Niti Raizada, MD
Fortis Hospital Ltd Bengaluru, Vinayak Munithrathnan, Dr.
Fundação Doutor Amaral Carvalho Jaú, Patricia Medeiros Milhomem Beato
GZA Ziekenhuizen Wilrijk,
Grandview Medical Center/Kettering Medical Center Kettering, Ohio Thomas Reid, MD
Gynecological Cancer Institute of Chicago, LLC Oak Lawn, Illinois Alfred Guirguis, DO
H Lee Moffitt Cancer Center and Research Institute Tampa, Florida Hye Sook Chon, MD
H.U. Fundacion Jimenez Diaz Madrid, Victoria Casado
Holy Name Medical Center Teaneck, New Jersey Sharyn Lewin, MD
Honor Health Scottsdale, Arizona Lyndsay Wilmott, MD
Hopital Maisonneuve-Rosemont d/b/a CIUSSS de l'Est-de-l'Île-de-Montréal Montréal, Quebec Lara DeGuerke, MD
Hospital Clinic de Barcelona Barcelona, Lydia Gaba Garcia, MD
Hospital De La Santa Creu I Sant Pau Barcelona, Catalonia Cristina Martin Lorente
Hospital General Universitario Gregorio Marañon Madrid, Sara Perez Ramirez
Hospital Santa Marcelina Sao Paulo, Roberto Odebrecht Rocha
Hospital Universitari Vall d'Hebron Barcelona, Juan Francisco Grau, MD
Hospital Universitario 12 de Octubre Madrid,
Hospital Universitario Virgen Macarena Seville, Andalusia Teresa Garcia Manrigue
Hospital Universitario Virgen de las Nieves Granada, Lucia Castillo Portellano
Hospital de Câncer de Barretos - Fundação Pio XII Barretos, Marina Costa Zorzetto, MD
ICESP - INSTITUTO DO CANCER DO ESTADO DE SAO PAULO OCTAVIO FRIAS de OLIVEIRA SĂŁo Paulo, Elias Abdo Filho
ICO l'Hospitalet-Hospital Duran i Reynals L'Hospitalet De Llobregat, Beatriz Pardo Burdalo
INCA - Instituto Nacional de Câncer Rio de Janeiro, Andréia Cristina de Melo
Icahn School of Medicine at Mount Sinai New York, New York Samanatha Cohen, MD
Illinois Cancer Specialists The Woodlands, Texas Urszula Sobol, MD
Instituto Valenciano de Oncologia IVO Valencia, Ignacio Romero Noguera
Instytut Centrum Zdrowia Matki Polki Lodz, Ewa Kalinka, PhD, MD
Investigacion Onco Farmaceutica S. de R.L. de C.V. (OncoTech) La Paz, Juan Paulo Ceja Garcia
John Muir Cancer Specialty Services Concord, California Babak Edraki, MD
John Muir Health Clinical Research Center Concord, California Babak Edraki, MD Peggy Newsom - (peggy.newsom@johnmuirhealth.com)
John Muir Health Gynecologic Cancer Services Walnut Creek, California Babak Edraki, MD
Kaiser Permanente Los Angeles Medical Center Los Angeles, California Devansu Tewari, MD
Kaiser Permanente Riverside Medical Center Riverside, California Devansu Tewari, MD
Kaiser Permanente Southern California Irvine, California Devansu S Tewari, MD
Kapiolani Medical Center for Women and Children/University of Hawaii Honolulu, Hawaii Michael Carney, MD
Karla Adriana Espinosa Bautista Mexico, Fernando Perez Zincer, MD
Koo Foundation Sun Yat-Sen Cancer Center Taipei, Chi-Feng Chung, MD
Korea Univ Anam Hsp Seoul, Kyong Hwa Park
Korea University Guro Hospital Seoul, Hyun-Woong Cho, MD
Lahey Hospital and Medical Center Burlington, Massachusetts Corrine Zarwan, MD
Lewis Cancer & Research Pavilion at St. Joseph's Candler Savannah, Georgia Sarah Gill, MD - (drgills@sjchs.org)
Lowell General Hospital Lowell, Massachusetts Sarah Paraghamian
Magee Women's Hospital of UPMC Pittsburgh, Pennsylvania Lan G Coffman, MD Brenda Lee Steele, RN,CCRC,CBCN - (steeleb@upmc.edu)
Magyar Honvedseg Egeszsegugyi Kozpont Budapest, Zsuzsanna Papai
Max Super Specialty Hospital Mohali, Gautam Goyal, MD
McGill University Health Centre/Glen Site/ Royal Victoria Hospital Montréal, Quebec Lucy Gilbert, MD
Memorial Herman Hospital Houston, Texas Joseph Lucci
Metro Minnesota Community Oncology Research Consortium Saint Louis Park, Minnesota Jessica Thomas-Pepin, MD
MetroWest Medical Center Framingham, Massachusetts Sarah Paraghamian, MD
Minnesota Oncology Hematology Minneapolis, Minnesota Jessica Thomes-Pepin, MD
Minnesota Oncology Hematology Minneapolis, Minnesota Jessica Thomes-Pepin, MD
Minnesota Oncology Hematology Minneapolis, Minnesota Jessica Thomes-Pepin, MD
Minnesota Oncology Hematology - Mercy Hospital Coon Rapids, Minnesota Jessica Thomes-Pepin, MD
Montefiore Medical Center PRIME Bronx, New York Nicole Nevandusky, MD
Moores UC San Diego Cancer Center La Jolla, California Ramez Eskander, MD
Mount Sinai - PRIME Lake Success, New York Samantha Cohen, MD
Mount Sinai The Blavatnik Family Chelsea Medical Center New York, New York Samantha Cohen, MD
MultiCare Institute for Research and Innovation Tacoma, Washington Christopher Breed, MD Min-Chun Chen, MD
MultiCare Regional Cancer Center - Auburn Auburn, Washington Christopher Breed, MD
MultiCare Regional Cancer Center - Tacoma Puyallup, Washington Christopher Breed, MD
MultiCare Regional Cancer Center-Gig Harbor Medical Park Gig Harbor, Washington Christopher Breed, MD
National Cancer Center Goyang-si Gyeonggi-do, Myong Cheol Lim
National Cheng Kung University Hospital Tainan City, Yu-Fang Huang, MD
National Taiwan University Hospital Taipei, Wen-Fang Cheng, MD
Nebraska Methodist Hospital Omaha, Nebraska Brent Tierney
Northwest Cancer Specialists, P.C.-Portland-Rose Quarter Portland, Oregon Erin Salinas, MD
Ohio State University Wexner Medical Center Columbus, Ohio Casey Cosgrove, MD
Oklahoma Cancer Specialist and Research Institution, LLC Tulsa, Oklahoma Michael A Gold, MD
Ospedale Clinicizzato SS. Annunziata Chieti, Michele De Tursi
Park Nicollet Frauenshuh Cancer Center Saint Louis Park, Minnesota Jessica Thomes-Pepin, MD
Parkview Research Center Fort Wayne, Indiana Iwona Podzielinski, MD
Portsmouth Regional Hospital Portsmouth, New Hampshire Sarah Paraghamian, MD
Prosalud Valparaíso, Pamela Salman Boghikian
Queen Elizabeth II Health Sciences Centre Halifax, Nova Scotia Karla Willows, MD
Radiotherapy Center Cluj SRL Flore?ti, Comuna Floresti Andrei Ungureanu, MD
Reading Hospital West Reading, Pennsylvania
Rocky Mountain Cancer Centers - Colorado Springs, N. Nevada Littleton, Colorado Manojkumar Bupathi, MD, MS
Ruby Hall Clinic Pune, Maharashtra Minish Jain
Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey Aliza Leiser
S.C Centrul de Oncologie Sf. Nectarie S.R.L Craiova, Michael Schenker, MD, PhD
S.C Gral Medical S.R.L Bucuresti, Cristina Tiut
S.C Medisprof S.R.L Cluj-Napoca, Anghel Adrian Udrea, MD, PhD
S.C Oncomed S.R.L Timişoara, Serban Mircea Negru
S.C Oncomed S.R.L Timişoara,
SCC at St. John's Medical Center Westlake, Ohio Kristine Zanotti, MD
SCC at UH Geauga Medical Center Chardon, Ohio Kristine Zanotti, MD
SMIQ S. de R.L. de C.V. Querétaro, Marco Antonio Garcia Hernandez, MD
Samsung Medical Center Seoul, Byoung-Gie Kim, Dr.
Sanatorio Parque S.A Salta, Miguel Angel Escudero, MD
Sanatorio de la Mujer Rosario, Santa Fe Province Cristina Marcela Nasurdi, MD
Sanford Research/USD-Sioux Falls Sioux Falls, South Dakota Maria Bell, MD
Seoul National University Bundang Hospital Seongnam-si, Gyeonggi-do, Yong Beom Kim
Seoul National University Hospital Seoul, Jae-Weon Kim, PhD, MD
Severance Hospital Yonsei University Health System Seoul, Jung-Yun Lee, MD, PhD
Severance Hospital, Yonsei University Health System Seoul, Min Hwan Kim
Siedleckie Centrum Onkologii Siedlce, Lubomir Bodnar
Sociedad de Investigaciones Medicas Limitada Temuco, Eduardo Yañez Ruiz
Sparrow Hospital Lansing, Michigan Rebecca Liu
St. Joseph Mercy Hospital Ann Arbor, Michigan Rebecca Liu, MD
St. Mary Mercy Livonia Hospital Livonia, Michigan Rebecca Liu
Stony Brook University Hospital Stony Brook, New York William Burke
Sushrut Hospital Mumbai, Sangeeta Jiwatani, MD
Szent Margit Korhaz Budapest, Katalin Boer
Taichung Veterans General Hospital Taichung, China Chien-Hsing Lu, MD
Taipei Veterans General Hospital Taipei, Peng-Hui Wang, MD
Texas Oncology DFWW Bedford, Texas Mark Messing, MD
Texas Oncology San Antonio Medical Center San Antonio, Texas Alfredo Santillan-Gomez, MD
Texas Oncology, P.A. Dallas, Texas Kristi McIntyre, MD
Texas Oncology, P.A. - Austin Austin, Texas Michael Teneriello, MD
Texas Oncology, P.A. - Fort Worth Fort Worth, Texas Noelle Cloven, MD
The Catholic University of Korea, Seoul St. Mary's Hospital Seoul, SookHee Hong
The Queens Medical Center Honolulu, Hawaii Keith Terada, MD
The University of Arizona Cancer Center Tucson, Arizona Setsuko K Chambers, MD
The Valley Hospital (Valley Health) Paramus, New Jersey Eleonora Teplinsky, MD
Tufts Medical Center Boston, Massachusetts Sarah Paraghamian, MD
Tufts Medical Center Cancer Center in Stoneham Stoneham, Massachusetts Sarah Paraghamian
UH Minoff Health Center - Seidman Orange Village, Ohio Kristine Zanotti, MD
UMass Memorial Medical Center Worcester, Massachusetts Susan Zweizig, MD
UPMC Hillman Cancer Center at UPMC Passavant Pittsburgh, Pennsylvania Lan G Coffman, MD Brenda Lee Steele, RN,CCRC,CBCN - (steeleb@upmc.edu)
Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez Monterrey, Omar Alejandro Zayas Villanueva
Universitair Ziekenhuis Antwerpen (UZA) Edegem, Sevilay Altintas
University Hospitals of Cleveland Cleveland, Ohio Kristine Zanotti, MD
University of California, Davis Comprehensive Cancer Center Sacramento, California Rebecca Brooks, MD
University of Colorado Health Aurora, Colorado Bradley Behbakht, MD
University of Connecticut Health Center Farmington, Connecticut Molly Brewer, MD
University of Minnesota Health - Maple Grove Clinic Maple Grove, Minnesota Jessica Thomes-Pepin, MD
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma Debra Richardson, MD
University of Pennsylvania Philadelphia, Pennsylvania Nawar Latif, MD, MPH
University of Tennessee at Chattanooga Chattanooga, Tennessee Stephen DePasquale, MD
University of Virginia Health Systems Charlottesville, Virginia Linda Duska, MD
University of Wisconsin Madison, Wisconsin Ellen Hartenbach, MD
Università Campus Bio-Medico di Roma Rome, Viterbo Roberto Angioli, MD
VCU Massey Cancer Center Richmond, Virginia Leslie Randall, MD
Vardhan Mahavir Medical College and Safdarjung Hospital New Delhi, Kaushal Kalra, Dr.
Virginia Cancer Specialists Arlington, Virginia Robert Marsh, MD
Virginia Oncology Associates - Hampton Norfolk, Virginia Michael McCollum
Vseobecna Fakultni Nemocnice v Praze Prague, David Cibula
Western Pennsylvania Hospital Pittsburgh, Pennsylvania Sarah Crafton
Willamette Valley Cancer Institute and Research Center Eugene, Oregon Charles Anderson, MD
Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszynskiego SPZOZ w Lublinie Lublin, Malgorzata Miacz, MD
Wojewodzki Szpital Specjalistyczny w Olsztynie Olsztyn, Warmia-Mazury Magdalena Sikorska, MD
Women & Infants Hospital of Rhode Island Providence, Rhode Island Elizabeth Lokich, MD - (lsegal@wihri.org)
Women's Cancer Associates St. Petersburg, Florida Megan D Indermaur, MD Cheryl L Ryder, ARNP
Women's Cancer Care/Mary Bird Perkins Cancer Center Covington, Louisiana Patricia Braly, MD
Womens Cancer Care Associates New York, New York Joyce Barlin
Yale University School of Medicine New Haven, Connecticut Alessandro Santin, MD
ZNA Middelheim Antwerp, Dirk Schrijvers
Zala Megyei Szent Rafael Korhaz Zalaegerszeg, Karoly Mahr, MD

Testing What Happens When an Immunotherapy Drug (Pembrolizumab) is Given by Itself Compared to the Usual Treatment of Chemotherapy With Radiation After Surgery for Recurrent Head and Neck Squamous Cell Carcinoma

Schaefer, Melissa - schaeferm@vcu.edu

Alesi, Erin, R.
PHASE2
NCT04671667
HM20022077
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Inclusion Criteria:
* Patient must be between 18 and 79 years of age * Patient must have locoregionally recurrent or second primary HNSCC (oral cavity, oropharynx, larynx, hypopharynx) in a previously radiated field * Patient must have undergone surgery with gross total resection and must be randomized within 8 weeks of surgery * Patients must have high risk disease defined as: * Positive margins and/or extra nodal extension (ENE) * Positive margins are defined as malignancy at or within 1 mm of the margin. High grade dysplasia (i.e. carcinoma in situ) at the margin is also considered positive * ENE may be either gross or microscopic * Patient must have a PD-L1 Combined Positive Score (CPS) \>= 1 in a Clinical Laboratory Improvement Act (CLIA) certified laboratory. Testing can be done locally as long as it is done in a CLIA certified laboratory. This testing must be on the tumor specimen from the resection of the patient's recurrent or second primary HNSCC * Patient must have had prior radiation to the area of recurrent or second primary tumor. This is defined as \> 50% of the presurgical tumor volume having previously received a dose of \> 45 Gy as determined by the treating radiation oncologist * Patient must have completed prior radiation a minimum of 6 months prior to randomization * Patient must not have any evidence of distant disease based on baseline imaging done within 28 days prior to randomization * Patient must not have received anti-PD-1/PD-L1 therapy for recurrent disease. If the patient received anti-PD-1/PD-L1 therapy as part of initial upfront curative intent treatment (either as part of definitive non-surgical therapy or in the adjuvant setting) in the past, the last dosage of anti-PD-1/PD-L1 therapy must have been given greater than one year prior to randomization * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * 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 * 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 randomization to rule out pregnancy. A urine or serum pregnancy test must be repeated within 72 hours prior to receiving the first dose of pembrolizumab or chemotherapy if the test done for eligibility/randomization is done outside of this 72 hour window. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. A patient of childbearing potential is someone, regardless of 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 must not expect to conceive or father children by using by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse while on study treatment, and continue for 120 days after the last dose of study treatment * Absolute neutrophil count (ANC) \>= 1,500/mcL (obtained =\< 28 days prior to protocol randomization) * Platelets \>= 100,000/mcL (obtained =\< 28 days prior to protocol randomization) * Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) (obtained =\< 28 days prior to protocol randomization) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 3.0 x institutional ULN (obtained =\< 28 days prior to protocol randomization) * Creatinine clearance \> 30 ml/min using the Cockcroft-Gault formula (obtained =\< 28 days prior to protocol randomization) * Patient must not have a current active infection that requires systemic treatment at time of randomization * Patient must not have a history of non-infectious pneumonitis requiring steroids within 3 years prior to randomization * Patient must not have a history of solid organ transplant or stem cell transplant * Patient must not be on immunosuppressive medication within 7 days prior to randomization, EXCEPT for the following: a) intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b) systemic corticosteroids at physiologic doses =\< 10 mg/day of prednisone or equivalent; c) steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) * 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. Patients with New York Heart Association class III or IV heart failure are not eligible * Patient must not have received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist \[registered trademark\]) are live attenuated vaccines and are not allowed * Patient must not have severe hypersensitivity (\>= grade 3) to pembrolizumab and/or any of its excipients * Patient must not have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed * Patient must not have a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial as long as they have not been HIV-infected with a history of Kaposi sarcoma and/or multicentric Castleman disease * Patient must not have a known history of hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or known active hepatitis C virus (defined as HCV ribonucleic acid \[RNA\] \[qualitative\] is detected) infection * NOTE: No testing for hepatitis B and hepatitis C is required unless mandated by a local health authority
DRUG: Carboplatin, DRUG: Cisplatin, PROCEDURE: Computed Tomography, RADIATION: Intensity-Modulated Radiation Therapy, PROCEDURE: Magnetic Resonance Imaging, BIOLOGICAL: Pembrolizumab, RADIATION: Proton Beam Radiation Therapy
Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Oral Cavity Squamous Cell Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma
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Study Locations

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Annie Penn Memorial Hospital Reidsville, North Carolina Site Public Contact - (stacey.phelps@conehealth.com)
Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Avera Cancer Institute Sioux Falls, South Dakota Site Public Contact - (OncRegulatory@avera.org)
Avera Cancer Institute at Yankton Yankton, South Dakota Site Public Contact - (OncRegulatory@avera.org)
Benefis Sletten Cancer Institute Great Falls, Montana Site Public Contact - (mccinfo@mtcancer.org)
Broadlawns Medical Center Des Moines, Iowa
California Protons Cancer Therapy Center San Diego, California
Cancer Care Specialists of Illinois - Decatur Decatur, Illinois
Cancer Centers of Southwest Oklahoma Research Lawton, Oklahoma
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)
Central Maryland Radiation Oncology in Howard County Columbia, Maryland
Clackamas Radiation Oncology Center Clackamas, Oregon
Cleveland Clinic Foundation Cleveland, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Community Medical Center Toms River, New Jersey Site Public Contact - (mccinfo@mtcancer.org)
Cone Health Cancer Center Greensboro, North Carolina Site Public Contact - (stacey.phelps@conehealth.com)
Crossroads Cancer Center Effingham, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Dayton Physician LLC - Englewood Dayton, Ohio
Dayton Physicians LLC-Atrium Franklin, Ohio
Dayton Physicians LLC-Miami Valley South Centerville, Ohio
Decatur Memorial Hospital Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Drexel Town Square Health Center Oak Creek, Wisconsin
Emory Proton Therapy Center Atlanta, Georgia Site Public Contact - (allyson.anderson@emory.edu)
Emory University Hospital Midtown Atlanta, Georgia
Emory University Hospital/Winship Cancer Institute Atlanta, Georgia
Fox Chase Cancer Center Philadelphia, Pennsylvania
Froedtert Menomonee Falls Hospital Menomonee Falls, Wisconsin
Froedtert West Bend Hospital/Kraemer Cancer Center West Bend, Wisconsin
Geisinger Medical Center Danville, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Medical Oncology-Lewisburg Lewisburg, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Greater Dayton Cancer Center Kettering, Ohio
HSHS Sacred Heart Hospital Eau Claire, Wisconsin
HSHS Saint Elizabeth's Hospital O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Heartland Oncology and Hematology LLP Council Bluffs, Iowa
Huntsman Cancer Institute/University of Utah Salt Lake City, Utah
Indu and Raj Soin Medical Center Beavercreek, Ohio
Iowa Lutheran Hospital Des Moines, Iowa
Iowa Methodist Medical Center Des Moines, Iowa
Jefferson Torresdale Hospital Philadelphia, Pennsylvania Site Public Contact - (ONCTrialNow@jefferson.edu)
John H Stroger Jr Hospital of Cook County Chicago, Illinois
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-Ontario Ontario, California Site Public Contact - (clinical.trials@kp.org)
Kettering Medical Center Kettering, Ohio
Logan Health Medical Center Kalispell, Montana Site Public Contact - (mccinfo@mtcancer.org)
Loyola University Medical Center Maywood, Illinois
Maryland Proton Treatment Center Baltimore, Maryland
Medical College of Wisconsin Milwaukee, Wisconsin
Medical University of South Carolina Charleston, South Carolina Site Public Contact - (hcc-clinical-trials@musc.edu)
Medstar Washington Hospital Center Washington D.C., District of Columbia
Memorial Health University Medical Center Savannah, Georgia
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
Methodist Jennie Edmundson Hospital Council Bluffs, Iowa Site Public Contact - (kathryn.bartz@nmhs.org)
Methodist West Hospital West Des Moines, Iowa
Miami Valley Cancer Care and Infusion Greenville, Ohio
Miami Valley Hospital North Dayton, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Miami Valley Hospital South Centerville, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Moffitt Cancer Center Tampa, Florida Site Public Contact - (ClinicalTrials@moffitt.org)
Moffitt Cancer Center - McKinley Campus Tampa, Florida Site Public Contact - (ClinicalTrials@moffitt.org)
Moffitt Cancer Center-International Plaza Tampa, Florida
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)
Mount Sinai Chelsea New York, New York Site Public Contact - (CCTO@mssm.edu)
Mount Sinai Hospital New York, New York Site Public Contact - (CCTO@mssm.edu)
Mount Sinai Union Square New York, New York Site Public Contact - (CCTO@mssm.edu)
Nebraska Cancer Specialists/Oncology Hematology West PC - MECC Omaha, Nebraska
Nebraska Methodist Hospital Omaha, Nebraska
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 Lake Forest Hospital Lake Forest, Illinois
Northwestern University Chicago, Illinois Site Public Contact - (cancer@northwestern.edu)
Oncology Associates PC Omaha, Nebraska
Premier Blood and Cancer Center Dayton, Ohio
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 Saint Vincent Medical Center Portland, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Randolph Hospital Asheboro, North Carolina
Reid Health Richmond, Indiana
Saint Francis Medical Center Cape Girardeau, Missouri
Saint Vincent Hospital Cancer Center Green Bay Green Bay, 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 Sturgeon Bay Sturgeon Bay, Wisconsin Site Public Contact - (wi_research_admin@hshs.org)
Sanford Bismarck Medical Center Bismarck, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford Joe Lueken Cancer Center Bemidji, Minnesota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford Roger Maris Cancer Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org)
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
Smilow Cancer Center/Yale-New Haven Hospital New Haven, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center - Waterford Waterford, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center-Trumbull Trumbull, Connecticut Site Public Contact - (canceranswers@yale.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)
Stony Brook University Medical Center Stony Brook, New York
Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville, California
Sutter Roseville Medical Center Roseville, California
Temple University Hospital Philadelphia, Pennsylvania
The Carle Foundation Hospital Urbana, Illinois
The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky
ThedaCare Regional Cancer Center Appleton, Wisconsin Site Public Contact - (ResearchDept@thedacare.org)
Thomas Jefferson University Hospital Philadelphia, Pennsylvania Site Public Contact - (ONCTrialNow@jefferson.edu)
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)
UC San Diego Moores Cancer Center La Jolla, California Site Public Contact - (cancercto@ucsd.edu)
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine, California Site Public Contact - (ucstudy@uci.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
UM Baltimore Washington Medical Center/Tate Cancer Center Glen Burnie, Maryland
UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables, Florida
UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach, Florida
UM Sylvester Comprehensive Cancer Center at Plantation Plantation, Florida
UPMC Altoona Altoona, Pennsylvania Site Public Contact - (ecog.rss@jimmy.harvard.edu)
UPMC Cancer Center at UPMC Horizon Farrell, Pennsylvania Site Public Contact - (ecog.rss@jimmy.harvard.edu)
UPMC Hillman Cancer Center - New Castle New Castle, Pennsylvania Site Public Contact - (haneydl@upmc.edu)
UPMC Hillman Cancer Center Erie Erie, Pennsylvania Site Public Contact - (haneydl@upmc.edu)
UPMC Memorial York, Pennsylvania
UPMC-Passavant Hospital Pittsburgh, Pennsylvania
UPMC-Saint Margaret Pittsburgh, Pennsylvania
UPMC-Shadyside Hospital Pittsburgh, Pennsylvania
University of Alabama at Birmingham Cancer Center Birmingham, Alabama
University of Arkansas for Medical Sciences Little Rock, Arkansas
University of Florida Health Science Center - Gainesville Gainesville, Florida
University of Illinois Chicago, Illinois
University of Kansas Cancer Center Kansas City, Kansas
University of Kansas Cancer Center - Lee's Summit Lee's Summit, Missouri
University of Kansas Cancer Center - North Kansas City, Missouri
University of Kansas Cancer Center at North Kansas City Hospital North Kansas City, Missouri
University of Kansas Cancer Center-Overland Park Overland Park, Kansas
University of Kansas Hospital-Indian Creek Campus Overland Park, Kansas
University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas
University of Kentucky/Markey Cancer Center Lexington, Kentucky
University of Maryland/Greenebaum Cancer Center Baltimore, Maryland
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan
University of Mississippi Medical Center Jackson, Mississippi
University of New Mexico Cancer Center Albuquerque, New Mexico Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu)
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma Site Public Contact - (ou-clinical-trials@ouhsc.edu)
University of Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania
University of Rochester Rochester, New York
UofL Health Medical Center Northeast Louisville, Kentucky Site Public Contact - (ctoinfo@louisville.edu)
Upper Valley Medical Center Troy, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
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)
Vanderbilt University/Ingram Cancer Center Nashville, Tennessee
Washington University School of Medicine St Louis, Missouri
Wayne State University/Karmanos Cancer Institute Detroit, Michigan
Weisberg Cancer Treatment Center Farmington Hills, Michigan
Wilmot Cancer Institute at Webster Webster, New York Site Public Contact - (WCICTOresearch@urmc.rochester.edu)
Yale University New Haven, Connecticut Site Public Contact - (canceranswers@yale.edu)

Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 3

Ryan Garten, PhD - rsgarten@vcu.edu

NA
NCT04916340
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Inclusion Criteria:
* apparently healthy and free of overt cardiovascular, pulmonary, or metabolic disease * for PTSD group, a score of ≥ 33 on PCL-5 checklist * for GAD group, a score of ≥ 10 on the GAD-7 self-report scale and \< 33 on the PCL-5 checklist * for Healthy Control group, a score of ≤ 10 on the GAD-7 self-report scale and \< 33 on the PCL-5 checklist
Exclusion Criteria:
* taking medications that could influence cardiovascular function * current smokers who have recently quit smoking * illicit drug use or excessive alcohol consumption * pregnant women * significant calorie restriction or vitamin/mineral deficiencies * limited English proficiency
BEHAVIORAL: Muscular Strength Training Group, BEHAVIORAL: Muscular Fitness Training Group
Peripheral Vascular Diseases
cardiovascular disease, vascular function, PTSD, GAD, Oxidant
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Virginia Commonwealth University Richmond, Virginia

Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 1

Ryan Garten, PhD - rsgarten@vcu.edu

NA
NCT04916327
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Inclusion Criteria:
* apparently healthy and free of overt cardiovascular, pulmonary, or metabolic disease * for PTSD group, a score of ≥ 33 on PCL-5 checklist * for GAD group, a score of ≥ 10 on the GAD-7 self-report scale and \< 33 on the PCL-5 checklist * for Healthy Control group, a score of ≤ 10 on the GAD-7 self-report scale and \< 33 on the PCL-5 checklist
Exclusion Criteria:
* taking medications that could influence cardiovascular function * current smokers who have recently quit smoking * illicit drug use or excessive alcohol consumption * pregnant women * significant calorie restriction or vitamin/mineral deficiencies * limited English proficiency
DIETARY_SUPPLEMENT: Antioxidant, DIETARY_SUPPLEMENT: Placebo
Peripheral Vascular Diseases
cardiovascular disease, vascular function, PTSD, GAD, Oxidant
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Virginia Commonwealth University Richmond, Virginia

Study of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral Immunodeficiency

Hyejoo Kim - hyejoo.kim@gccorp.com

Zhao, Wei
Phase 3
NCT04565015
HM20021702
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Inclusion Criteria:

• Subject must be ≥ 2 to < 17 years of age, at the time of signing the informed consent
• Pediatric subject has a confirmed and documented clinical diagnosis of Primary Humoral Immunodeficiency, including hypogammaglobulinemia or agammaglobulinemia
• Subject who has received 300 - 900 mg/kg of IGIV therapy at 21 or 28 day intervals for at least 3 months prior to this study
• Subject who has at least 2 documented plasma IgG trough level of ≥ 500 mg/dL at two infusion cycles (21 or 28 days) within 12 months prior to enrollment
• Subject who is willing to comply with all requirements of the protocol
Exclusion Criteria:

• Subject who has a history of clinically significant reactions or hypersensitivity to IGIV or other injectable forms of IgG
• Subject who has IgA deficiency and is known to have antibodies to IgA
• Subject who has secondary immunodeficiency
• Subject who has participated in another clinical study (other than an IGIV study) within 3 weeks prior to screening
• Subject who has been diagnosed with dysgammaglobulinemia or isolated IgG subclass deficiency or isolated IgA deficiency, or who has clinically significant impairment of cellular or innate immunity at the discretion of the Investigator
• Subject who has received blood products other than human albumin or human immune globulin within 6 months prior to enrollment
Biological: GC5107
Primary Immune Deficiency
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Allergy Partners of North Texas Research Dallas, Texas
Children's Hospital of Richmond at VCU Richmond, Virginia
Lysosomal and Rare Disorders Research and Treatment Center, Inc. Fairfax, Virginia
Oklahoma Institute of Allergy & Asthma Clinical Research, LLC Oklahoma City, Oklahoma
University of Wisconsin Madison, Wisconsin

A Study of Rilematovir in Infants and Children and Subsequently in Neonates Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV) (DAISY)

Study Contact - JNJ.CT@sylogent.com

Phase 3
NCT04583280
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Inclusion criteria:
• The participant weighs within greater than or equal to (>=) 2.4 kilograms (kg) and less than or equal to (<=) 24.6 kg
• Each participant's parent(s) (preferably both if available or as per local requirements) or their legally acceptable representative(s) has/have signed an informed consent form (ICF) indicating that (s)he understands the purpose of, and procedures required for, the study; is willing for their child to participate in the study; with regards to the concomitant medication, the lifestyle consideration and study procedures and assessments to be performed by the parent(s)/caregiver(s) as well as those by the investigator/study site personnel
• The participant has an acute respiratory illness with at least 1 of the signs/symptoms within 24 hours prior to start of screening and at screening, as evaluated by the investigator in Upper respiratory tract infection: nasal congestion or rhinorrhea; and Lower respiratory tract infection: increased respiratory effort (as evidenced by subcostal, intercostal or tracheosternal retractions, grunting, head bobbing, nasal flaring, or tachypnea), wheezing, cough, cyanosis, or apnea; and systemic/general: feeding difficulties (defined as <75 percent [%] intake of normal food amounts); dehydration; fever; disturbed sleep, or disturbed activity level (irritable/restless/agitated/less responsive). Cough or wheezing cannot be the only LRTI sign/symptom present, that is, at least one other LRTI sign/symptom needs to be present for eligibility
• The time of onset of RSV signs/symptoms to the anticipated time of randomization must be less than or equal to (<=) 3 days. Onset of signs/symptoms is defined as the time of the day (or part of the day if time of the day cannot be specified) the parent(s)/caregiver(s) became aware of the first sign and/or symptom consistent with respiratory or systemic/general manifestation of signs/symptoms of RSV infection. The time of sign/symptom onset has to be assessed as accurately as possible
• Participants are otherwise healthy or have (a) risk factor(s) for severe RSV disease Exclusion criteria:
• The participant has had either confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection (test positive) during the four weeks prior to randomization, or close contact with a person with COVID-19 (test confirmed or suspected SARS CoV-2 infection) within 14 days prior to randomization
• Confirmed QT interval corrected for heart rate according to Fridericia's formula (QTcF) interval greater than (>) 450 milliseconds (msec) per the machine read parameter result at screening. Presence of an abnormal QTcF interval should be confirmed by repeat electrocardiogram (ECG) recording during screening
• Known personal or family history of Long QT Syndrome or sudden cardiac death
• Presence of repetitive ventricular premature contractions (>10/minutes [min]), second- or third-degree heart block, or complete or incomplete left bundle branch block, or complete right bundle branch block per the machine read ECG result at screening. Presence of any of the above abnormalities should be confirmed by repeat ECG recording during screening
Drug: Rilematovir, Drug: Rilematovir X mg/kg, Drug: Placebo
Respiratory Tract Infections
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A.O.U Sant'Orsola-Malpighi Bologna,
AOU Meyer Firenze,
ASST Fatebenefratelli Sacco / Ospedale dei Bambini V. Buzzi Milano,
AZ Sint-Jan Brugge-Oostende AV Bruges,
Acibadem City Clinic Tokuda Hospital Sofia,
Ankara Sehir Hastanesi Ankara,
Ankara University Medical Faculty Ankara, Altindag
Arkhangelsk Regional Clinical Hospital Arkhangelsk,
Arnold Palmer Hospital for Children Orlando, Florida
Astrid Lindgrens barnsjukhus Solna Stockholm,
Atrium Health Charlotte, North Carolina
Azienda Ospedaliera Di Padova Padua,
Azienda Ospedaliera di Pavia-(Ospedale Civile di Vigevano) Vigevano,
Bacs-Kiskun Megyei Korhaz Kecskemét,
Bamrasnaradura Infectious Disease Institute Nonthaburi,
Barzilai Medical Center Ashkelon,
Bashkir State Medical University Ufa,
Beijing Children's Hospital, Capital Medical University Beijing,
Bethesda Gyermekk?rh Budapest,
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz Miskolc,
Botucatu Medical School S?o Paulo Botucatu,
CHA Bundang Medical Center, CHA University Seongnam-si,
CHOC Childrens Orange, California
CHU Charleroi Lodelinsart,
Capital Institute of Pediatrics Beijing,
Centro M?dico Zambrano Hellion Monterrey, Nuevo Le
Centro de Estudos e Pesquisas em Mol?stias Infecciosas Natal,
Centro de Pesquisa Cl?nica Hospital Moinhos de Vento Porto Alegre,
Cevaxin Avenida Mexico Panama,
Chang Gung Medical Foundation Kaohsiung City,
Children hospital #1 Tomsk,
Children's Clinical University Hospital Riga,
Children's Hospital Colorado Aurora, Colorado
Children's Hospital of Chongqing Medical University Chongqing,
Children's Hospital of Fudan University Shanghai,
Children's Hospital of Richmond at VCU Richmond, Virginia
Chong Hua Hospital Cebu City,
Clinica Mayo de UMCB San Miguel de Tucuman,
Cliniques Universitaires Saint-Luc Brussels,
Complejo Hosp. de Navarra Pamplona,
Complexo Hospital de Clinicas - UFPR Curitiba,
Csolnoky Ferenc Korhaz Veszpr,
Cukurova University Medical Faculty Balcali Hospital Adana,
D.Y.Patil Medical College Pune,
DFNsP Banska Bystrica Banska Bystrica,
Daido Hospital Nagoya,
Dalian municipal and Children's Medical Center(Group) Dalian,
Datta Meghe Institute of Medical Sciences Wardha,
Daugavpils Regional Hospital Daugavpils,
De La Salle Health Sciences Institute- DLSUMC Dasmarinas,
Debreceni Egyetem Klinikai Kozpont Debrecen, Hajdú-Bihar
Department of Pediatrics University of Pavia, Policlinico San Matteo Pavia,
Dzieciecy Szpital Kliniczny im. Jozefa Polikarpa Brudzinskiego Warszawa,
Ege University Medical Faculty Izmir,
Esza-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo Budapest,
Ev. Krankenhaus Hamm gGmbH Hamm,
Faculty of Medicine Chulalongkorn University Pathumwan,
Fakultni nemocnice Brno Brno,
Fakultni nemocnice Brno Brno,
Fakultni nemocnice Hradec Kralove Hradec Králové,
Fakultni nemocnice Kralovske Vinohrady Prague,
Falu Lasarett Falun,
Fukui Prefectural Hospital Fukui,
Fukuyama City Hospital Fukuyama,
Fundacao Jose Luiz Egydio Setubal S?o Paulo,
G B Pant Hospital & Maulana Azad Medical College, New Delhi New Delhi,
Gazi University Medical Faculty Ankara,
Guangzhou Women And Children's Medical Center Guangzhou,
HELIOS Klinikum Wuppertal GmbH Wuppertal,
HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas Campinas,
Hacettepe University Medical Faculty Ankara,
Hebrew University Hadassah Medical Center Jerusalem,
Henan Children's Hospital, Zhengzhou Children's Hospital Zhengzhou,
Hosp. Clinico Univ. de Santiago Santiago de Compostela,
Hosp. Puerta Del Sur Mostoles,
Hosp. Quiron Madrid Pozuelo Pozuelo de Alarcón,
Hosp. Reina Sofia Córdoba,
Hosp. Sant Joan de Deu Esplugues de Llobregat,
Hosp. Univ. 12 de Octubre Madrid,
Hosp. Univ. Fund. Jimenez Diaz Madrid,
Hosp. Univ. Germans Trias I Pujol Badalona,
Hosp. Univ. Hm Monteprincipe Madrid,
Hosp. Univ. La Paz Madrid,
Hosp. Univ. Pta. de Hierro Majadahonda Majadahonda,
Hosp. Univ. Severo Ochoa Madrid,
Hosp. Univ. de Cruces Barakaldo,
Hosp. Univ. de Getafe Getafe,
Hospital Bintulu Bintulu,
Hospital General De Ninos Pedro De Elizalde Buenos Aires,
Hospital General Dr. Manuel Gea Gonz?lez Tlalpan,
Hospital Infantil de Mexico Federico Gomez Ciudad De Mexico, DF
Hospital Interzonal General de Agudos Dr. Jose Penna Bahia Blanca,
Hospital Italiano Regional Del Sur Bahía Blanca,
Hospital Miri Miri, Sarawak
Hospital Sedna Ciudad de Mexico,
Hospital Selayang Batu Caves,
Hospital Sibu Sibu, Sarawak
Hospital Taiping Taiping,
Hospital Universitario 'Dr. Jose Eleuterio Gonzalez' Monterrey,
Hospital Universitario Austral Pilar, Buenos Aires
Hospital Wanita dan Kanak-Kanak Sabah Kota Kinabalu,
Hospital das Cl?nicas da Faculdade de Medicina de Ribeir?o Preto - USP Ribeir?o Preto,
Hospital de Clinicas da Universidade Federal De Minas Geraisnas Gerais Belo Horizonte,
Hospital de Messejana dr. Carlos Alberto Studart Gomes Fortaleza,
Hospital del Ni?o Jes San Miguel de Tucum,
Hsinchu MacKay Memorial Hospital Hsinchu,
IRCCS Materno Infantile Burlo Garofolo Trieste,
IRCCS Ospedale Pediatrico Bambino Gesu Roma,
Inje University Sanggye Paik Hospital Seoul,
Instituto M?dico R?o Cuarto Rio Cuarto,
Instituto Nacional de Enfermedades Respiratorias Tlalpan,
Instituto Nacional de Pediatr Coyoacan,
Instytut Pomnik - Centrum Zdrowia Dziecka Warszawa,
Istanbul University Istanbul Medical Faculty Istanbul,
Istituto Giannina Gaslini Genoa,
Jacobi Medical Center The Bronx, New York
Japan Community Health Care Organization Kyushu Hospital Kitakyushu-shi,,
Jekabpils Hospital Jekabpils,
Jiangxi Provincial Children's Hospital Nanchang,
KEM Hospital & Research Centre Pune, Maharashtra
Kagoshima Children's Hospital Hioki,
Kangbuk Samsung Hospital Seoul,
Karadeniz Teknik University Medical Faculty Trabzon,
Kasturba Medical College Hospital Manipal, Karnataka
Kharkiv National Medical University on based CHPI Kharkiv Municipal Clinical Children's Hospital 16 Kharkiv,
Klinik f?r Kinder-und Jugendmedizin der Ruhr-Uni-Bochum im St. Josef-Hospital Bochum,
Klinika det? a dorastu, UNM Martin Martin,
Kobe City Medical Center General Hospital Kobe,
Kochi Health Sciences Center Kochi,
Korea Institute of Radiological and Medical Sciences Seoul,
Krakowski Szpital Specjalistyczny im Jana Pawla II Krakow,
Kyungpook National University Hospital Daegu,
Le Bonheur Children's Hospital Memphis, Tennessee
Lung Center Of The Philippines Quezon City,
M S Ramaiah Medical College and Hospital Bangalore,
ME 'Dnipropetrovsk Regional Children's Clinical Hospital of Dnipropetrovsk Regional Council' Dnipro,
MNPE City Children's Clinical Hospital ? 6 of Dnipro City Council Dnipro,
MNPE City Children's Clinical Hospital ? 6 of Dnipro City Council Dnipro,
MNPE Vinnytsia Regional Children's Clinical Hospital National Medical University named after M.I. Pirigov Vinnytsia,
MNPE Zaporizhzhya Regional Clinical Children's Hospital of Zaporizhzhya Regional Council Zaporizhzhia,
MUNICIPAL NON-PROFIT ENTERPRISE 'Kryvyi Rih CITY HOSPITAL ?16' Kryvyi Rih CITY COUNCIL Kryvyi Rih,
Mackay Memorial Hospital Taipei,
Maebashi Red Cross Hospital Maebashi-shi, Gunma,
Maharaj Nakorn Chiangmai Hospital Chiang Mai,
MultiCare Health Systems for Research and Innovation Tacoma, Washington
Municipal Medical Institution Regional Children's Clinical Hospital Chernivtsi,
Municipal Non-Profit Enterprise 'City Clinical Hospital #9' of the Dnipro City Council Dnipro,
Municipal institution 'Vinnytsia Regional Clinical Children's Infectious Diseases Hospital' Vinnytsia,
National Hospital Organization Beppu Medical Center Beppu, Oita
National Hospital Organization Kanazawa Medical Center Kanazawa, Ishikawa
National Hospital Organization Niigata National Hospital Niigata,
National Hospital Organization Sagamihara National Hospital Sagamihara-shi, Kanagawa,
National Hospital Organization Saitama National Hospital Saitama,
National Hospital Organization Ureshino Medical Center Ureshino-shi,
National Taiwan University Hospital Taipei,
Nemocnice Ceske Budejovice, a.s. Ceske Budejovice,
Nowon Eulji Medical Center, Eulji University Seoul,
Nucleo de Pesquisa do Hospital Pequeno Princ?pe Curitiba,
Odessa Regional Child Hospital Odessa,
Osaka Asahi Children's Hospital Osaka,
Ospedale degli Infermi Rivoli,
Pediatric Pulmonology Clinic, University Hospital Bratislava Bratislava,
Pediatrics B, Safra Children's Hospital, Tel Hashomer Ramat Gan,
Peking University Third Hospital Beijing,
Petz Aladar Megyei Oktato Korhaz Győr,
Philippine Children's Medical Center Quezon City, Metro Manila
Philippine General Hospital Taft, Manila,
Philippine Heart Center Quezon City,
Pusan National University Hospital Busan,
Qualimed Hospital Nuvali Sta. Rosa,
Rady Children's Hospital-San Diego San Diego, California
Ruth Rappaport Children's Hospital, Rambam Health Care Campus Haifa,
SHATCD 'Prof. Ivan Mitev' EAD Sofia,
SSU Division MU Ch of pediatrics of PGE with propedeutic pediatrics and children infections course Sumy,
Sachsska barn-och ungdomssjukhuset Stockholm,
Saglik Bilimleri University Sariyer Hamidiye Etfal Training and Research Hospital Sar?yer,
Samsung Medical Center Seoul,
Sanford Health Sioux Falls, South Dakota
Santa Casa de Miseric?rdia de Votuporanga Votuporanga,
Santa Casa de Misericordia de Belo Horizonte Belo Horizonte,
Schneider Children's Medical Center Petach Tikva,
Semmelweis Egyetem, II. sz. Gyermekgyogyaszati Klinika Budapest,
Severance Hospital, Yonsei University Health System Seoul,
Shanghai Children's Hospital Shanghai,
Shengjing Hospital of China Medical University Shengyang,
Shenzhen Children's Hospital Shenzhen,
Shree Krishna Hospital and Medical Research Center Karamsad,
Sir Ganga Ram Hospital New Delhi, National Capital Territory of Delhi
Siriraj Hospital Mahidol University Bangkok,
Smolensk State Medical University Smolensk,
Soroka University Medical Center Beersheba,
Sourasky MC Tel-Aviv,
Southern Philippines Medical Center Davao City, Davao DEL SUR
Specialistic Hospital Center for Mother and Child Pozna?,
Spectrum Health System Grand Rapids, Michigan
Sri ramchandra Medical College & Research Institute Chennai,
Srinagarind Hospital Khon Kaen,
St Luke's Hospital Boise, Idaho
St. Luke's Medical Center Milwaukee, Wisconsin
Sumy Regional Childrens Clinical Hospital Sumy,
Szegedi Tudomanyegyetem Szeged,
Taipei Medical University Shuang Ho Hospital New Taipei City,
Tallinn Children's Hospital Tallinn,
Tartu University Hospital Tartu,
Teine Keijinkai Hospital Sapporo, Hokkaido
The First Affiliated Hospital of Xiamen University Xiamen, Fujian
The First Bethune Hospital of Jilin University Changchun, Jilin
Thomayerova nemocnice Praha 4 - Krc,
Tropical Medicine Hospital, Mahidol University Bangkok,
Tufts Medical Center Boston, Massachusetts
ULB H?pital Erasme Brussels,
UMHAT 'Aleksandrovska' EAD Sofia,
UMHAT 'Dr. Georgi Stranski', EAD Pleven,
UMHAT 'Kanev' EAD Ruse,
UMHAT 'Sveti Georgi'-Plovdiv Plovdiv,
UZ Brussel Brussels,
UZ Gent Ghent,
UZ Leuven Leuven,
Universit? degli Studi di Milano, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan,
Universit?tsklinikum M?nster M?nster, Nordrhein-Westfalen
Universit?tsklinikum W?rzburg W?rzburg, Bayern
Universitaetsklinikum Hamburg Eppendorf Hamburg,
Universitaetsklinikum Tuebingen Tübingen, Baden-Wurttemberg
Universitatsklinik Freiburg Freiburg,
University of Arizona Health Sciences Center Tucson, Arizona
University of Minnesota Masonic Childrens Hospital Minneapolis, Minnesota
University of Mississippi Medical Center Jackson, Mississippi
University of South Florida Tampa, Florida
University of Utah Salt Lake City, Utah
Uniwersytecki Szpital Dzieciecy w Lublinie Lublin,
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu Wroclaw,
West China Second University Hospital, Sichuan University Chengdu, Sichuan
West Virginia University Morgantown, West Virginia
West Visayas State University Medical Center Iloilo City,
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Lodz,
Yale University School of Medicine New Haven, Connecticut
Yamanashi Prefectural Central Hospital Kofu-shi,
Zespol Opieki Zdrowotnej w Debicy, Oddzial Dzieciecy Debica,
Ziekenhuis Oost-Limburg Genk,
hospital Italiano de Buenos Aires CABA,

T-DM1 and Tucatinib Compared with T-DM1 Alone in Preventing Relapses in People with High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial

Ciara C. O'Sullivan, MB, BCh, BAO - osullivan.ciara@mayo.edu

Vachhani, Hetal
PHASE3
NCT04457596
HM20021840
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Inclusion Criteria:
* HER2-positive status will be based on pretreatment biopsy material and defined as an immunohistochemistry (IHC) score of 3+ and/or positive by in situ hybridization (ISH) according to current American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines. Central testing is not required \* Known hormone receptor (HR) status as defined by ASCO/CAP guidelines (based on pretreatment biopsy material). Hormone receptor positive status can be determined by either known positive estrogen receptor (ER) or known positive progesterone receptor (PR) status; hormone receptor negative status must be determined by both known negative ER and known negative PR * Patients with clinical stage T1-4, N0-3 disease at presentation and residual invasive disease postoperatively as defined above are eligible. (Note: Patients with T1a/bN0 tumors are not eligible at initial breast cancer diagnosis are not eligible) * Patients with residual HR-negative, HER2 positive (+) disease in the breast and/or lymph nodes per the surgical pathology report are eligible; however, patients with HR+ HER2+ cancers must have node-positive residual disease per the surgical pathology report in order to qualify for the study. The presence of residual invasive disease in the breast is not mandatory for these patients * Patients with weakly ER-positive (1-10%) breast cancer (based on the pretreatment core biopsy) are eligible even if they have node-negative disease per the surgical pathology report * The residual disease tissue (breast and/or lymph nodes) is not required to be HER2-positive, as eligibility for NCI-2020-03770 (A011801) is based on a positive HER2 status at the time of the initial breast cancer diagnosis \* Note: The presence of micrometastases in lymph nodes after preoperative therapy counts as residual disease, whereas the presence of isolated tumor cells does not * Patients with synchronous bilateral invasive disease are eligible provided both lesions were confirmed to be HER2-positive, and at least one of the lesions meets the criteria outlined above. Multifocal disease is allowed, as long as the largest biopsied breast tumor was HER2-positive * Patients must have received neoadjuvant chemotherapy with one of the following regimens: docetaxel/trastuzumab/pertuzumab (THP), paclitaxel/methotrexate/cisplatin (TMP), doxorubicin/cyclophosphamide/paclitaxel/trastuzumab/pertuzumab (AC-TH(P)); docetaxel/carboplatin/trastuzumab/pertuzumab (TCH(P)); fluorouracil/doxorubicin/cyclophosphamide-docetaxel/trastuzumab/pertuzumab (FAC-TH(P)), or fluorouracil/epirubicin/cyclophosphamide-docetaxel/trastuzumab/pertuzumab (FEC-TH(P)). Note: apart from TCHP, where T is docetaxel, treatment with docetaxel or paclitaxel is acceptable * Prior receipt of T-DM1 in the neoadjuvant setting is not allowed. * Prior treatment must have consisted of \>= 6 cycles of chemotherapy and HER2-directed therapy, with a total duration of \>= 12 weeks, including at least 9 weeks of preoperative taxane and trastuzumab with or without pertuzumab (or Food and Drug Administration \[FDA\]-approved biosimilars). Patients who have received at least 9 weeks of preoperative taxane, pertuzumab and margetuximab are also eligible if they received \>= 6 cycles of systemic therapy prior to enrollment. Note: Patients who complete at least nine of a planned twelve doses of weekly paclitaxel, or three of a planned four doses of docetaxel, but discontinue prematurely due to toxicity are eligible. Patients receiving dose-dense chemotherapy regimens are also eligible. Prior use of nab-paclitaxel (Abraxane) instead of paclitaxel or docetaxel is permitted. Prior use of subcutaneous trastuzumab (Hylecta) and subcutaneous trastuzumab and pertuzumab (Phesgo) is also allowed. * Patients who received neoadjuvant systemic therapy which included experimental HER2-targeted therapy/therapies are potentially eligible, as long as the investigational agent was not a HER2-targeted antibody-drug conjugate (e.g. T-DM1, DS-8201a \[trastuzumab deruxtecan\]) or a HER2 targeted tyrosine kinase inhibitor (TKI) (e.g. tucatinib, lapatinib, neratinib). * Patients may have received =\< 1 cycles of T-DM1 in the adjuvant setting. Note: These patients will be randomized to receive a further 14 cycles of T-DM1 and tucatinib/placebo as tolerated. The most recent cycle of T-DM1 should have been administered =\< 5 weeks prior to registration \* Note: Both of the following two criteria need to be met for the patient to be eligible for this study * An interval of no more than 12 weeks between the completion date of the last definitive treatment (e.g. postoperative chemotherapy or radiation, or if neither given, breast surgical date) and the date of registration. Concurrent radiation therapy is permitted while receiving study treatment * Patients must be registered on study within =\< 180 days of the date of the most recent definitive breast cancer surgery (not including reconstructive surgery) * All systemic chemotherapy should have been completed preoperatively unless participating in EA1181 (CompassHER2 pathologic complete response \[pCR\]) or the BIG DECRESCENDO Trial (which is very similar to CompassHER2 pCR in terms of study design, drugs, and eligibility). However, patients who received 4 cycles of neoadjuvant THP off study can receive a further 2-4 cycles of chemotherapy postoperatively to meet eligibility for A011801. Patients who participated in EA1181 or MA41 and proceeded to surgery immediately after the de-escalated trial regimen must receive postoperative chemotherapy to complete a total of \>= 6 cycles of systemic treatment prior to enrollment on A011801, as outlined above (e.g. 4 cycles pre-operatively, and 2 cycles post-operatively). The postoperative chemotherapy regimen prescribed is at the discretion of the treating oncologist (i.e. 2-4 cycles AC or THP, other). Continuation of trastuzumab + pertuzumab (HP) pre- or post-operatively as maintenance therapy (while awaiting a surgical date or an official pathology report) is allowed for all study participants * Toxicities related to prior systemic treatment should have resolved or be at baseline, apart from alopecia and peripheral neuropathy =\< grade 1 * Adequate excision: surgical removal of all clinically evident disease in the breast and lymph nodes as follows: * Breast surgery: total mastectomy with no gross residual disease at the margin of resection, or breast-conserving surgery with histologically negative margins of excision * For patients who undergo breast-conserving surgery, the margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional operative procedures may be performed to obtain clear margins. If tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. Patients with margins positive for classic lobular carcinoma in situ (LCIS) are eligible without additional resection * Lymph node surgery \*\* The axilla needs to be evaluated with either sentinel node biopsy or axillary lymph node dissection. If patients have a sentinel lymph node biopsy and sentinel nodes are negative, no further axillary treatment is necessary. If patients have isolated tumor cells (ITCs) in the setting of residual breast disease, at least one of the following is required: axillary lymph node dissection (ALND) or planned nodal irradiation. If patients have micro- or macro-metastatic nodal disease, ALND and planned nodal irradiation are required. Of note, co-enrollment on Alliance A011202 is not allowed * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Absolute neutrophil count (ANC) \>= 1,000/mm\^3 * Hemoglobin \>= 8 g/dL (Note: packed red blood cells \[PRBC\] transfusion is not permitted to achieve eligibility) * Platelet count \>= 100,000/mm\^3 * Creatinine =\< 1.5 x upper limit of normal (ULN) * Total bilirubin =\< 1.0 x upper limit of normal (ULN) or direct bilirubin within the institutional normal range for patients with Gilbert's syndrome * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN) * Screening left ventricular ejection fraction (LVEF) \>= 50% on echocardiogram (ECHO) or multiple-gated acquisition (MUGA) after receiving neoadjuvant chemotherapy and no decrease in LVEF by more than 15% absolute percentage points from the pre-chemotherapy LVEF. Or, if pre-chemotherapy LVEF was not assessed, the screening LVEF must be \>= 55% after completion of neoadjuvant chemotherapy. Note: LVEF assessment may be repeated once up to 3 weeks following the initial screening assessment to assess eligibility
Exclusion Criteria:
* No adjuvant treatment with any anti-cancer investigational drug within 28 days prior to registration * Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative serum pregnancy test done =\< 7 days prior to registration is required * Patients with known active and/or untreated hepatitis B or hepatitis C or chronic liver disease are ineligible. Patients with a diagnosis of hepatitis B or C that has been treated and cleared and normal liver function are eligible to participate in the study if the other eligibility parameters are met * Stage IV (metastatic) breast cancer * History of any prior (ipsi- or contralateral) invasive breast cancer within 3 years of registration * Patients with ER+ HER2+ residual invasive disease that is lymph node-negative per the surgical pathology report * Evidence of recurrent disease following preoperative therapy and surgery * Patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons (e.g., connective tissue disorder or prior ipsilateral breast radiation) * History of exposure to the following cumulative doses of anthracyclines: doxorubicin \> 240 mg/m\^2; epirubicin or liposomal doxorubicin-hydrochloride (Myocet) \> 480 mg/m\^2. For other anthracyclines, exposure equivalent to doxorubicin \> 240 mg/m\^2 * Cardiopulmonary dysfunction as defined by any of the following: * History of National Cancer Institute (NCI) CTCAE version (v) 5.0 grade \>= 3 symptomatic congestive heart failure (CHF) or New York Heart Association (NYHA) criteria class \>= II * Angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease * High-risk uncontrolled arrhythmias: i.e., atrial tachycardia with a heart rate \> 100/min at rest, significant ventricular arrhythmia (ventricular tachycardia) or higher-grade atrioventricular block (AV)-block (second degree AV-block type 2 \[Mobitz 2\] or third degree AV-block) * Significant symptoms (grade \>= 2) relating to left ventricular dysfunction, cardiac arrhythmia, or cardiac ischemia while or since receiving preoperative therapy * History of a decrease in left ventricular ejection fraction (LVEF) to \< 40% with prior trastuzumab treatment (e.g., during preoperative therapy) * Uncontrolled hypertension (systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg) * Current severe, uncontrolled systemic disease * Major surgical procedure unrelated to breast cancer or significant traumatic injury within 28 days prior to registration or anticipation of the need for major surgery during the course of study treatment * History of intolerance, including grade 3 to 4 infusion reaction or hypersensitivity to trastuzumab or murine proteins or any components of the product * Peripheral neuropathy of any etiology that exceeds grade 1 * Assessment by the investigator as being unable or unwilling to comply with the requirements of the protocol * Use of a strong CYP3A4 or CYP2C8 inhibitor within 2 weeks, or use of a strong CYP3A4 or CYP2C8 inducer within 5 days prior to registration is prohibited. * Please note that use of sensitive CYP3A substrates should be avoided two weeks before registration and during study treatment. Additionally, CYP3A4 or CYP2C8 inducers are prohibited as concomitant medications within 5 days following discontinuation of tucatinib treatment. Patients who require medications that are known to be sensitive substrates of CYP3A4 with a narrow therapeutic window should be excluded.
BIOLOGICAL: Trastuzumab Emtansine, DRUG: Placebo Administration, DRUG: Tucatinib, OTHER: Questionnaire Administration, OTHER: Quality-of-Life Assessment
Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, HER2 Positive Breast Carcinoma, Invasive Breast Carcinoma, Multifocal Breast Carcinoma, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage IA Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8, Synchronous Bilateral Breast Carcinoma
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Location Contacts
AMG Crystal Lake - Oncology Crystal Lake, Illinois Site Public Contact - (advocateresearch@advocate.com)
AMG Libertyville - Oncology Libertyville, Illinois Site Public Contact - (advocateresearch@advocatehealth.com)
Abbott-Northwestern Hospital Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Academic Hematology Oncology Specialists Grosse Pointe Woods, Michigan
Adams Cancer Center Gettysburg, Pennsylvania
Addison Gilbert Hospital Gloucester, Massachusetts
Adena Regional Medical Center Chillicothe, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Advanced Breast Care Center PLLC Warren, Michigan
AdventHealth Altamonte Altamonte Springs, Florida
AdventHealth Celebration Celebration, Florida
AdventHealth East Orlando Orlando, Florida
AdventHealth Kissimmee Kissimmee, Florida
AdventHealth Medical Group Urology at Orlando Orlando, Florida
AdventHealth Orlando Orlando, Florida Site Public Contact - (FH.Cancer.Research@flhosp.org)
AdventHealth Winter Park Winter Park, Florida
Advocate Christ Medical Center Oak Lawn, Illinois
Advocate Good Samaritan Hospital Downers Grove, Illinois Site Public Contact - (Barbara.barhamand@advocatehealth.com)
Advocate Good Shepherd Hospital Barrington, Illinois
Advocate Illinois Masonic Medical Center Chicago, Illinois
Advocate Lutheran General Hospital Park Ridge, Illinois
Advocate Sherman Hospital Elgin, Illinois
Advocate South Suburban Hospital Hazel Crest, Illinois
Alaska 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
Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada
Alta Bates Summit Medical Center - Summit Campus Oakland, California
Alta Bates Summit Medical Center-Herrick Campus Berkeley, California Site Public Contact - (NCIclinicaltrials@sutterhealth.org)
Anchorage Associates in Radiation Medicine Anchorage, Alaska
Anchorage Oncology Centre Anchorage, Alaska
Anchorage Radiation Therapy Center Anchorage, Alaska
Ann M Wierman MD LTD Las Vegas, Nevada
Annie Penn Memorial Hospital Reidsville, North Carolina Site Public Contact - (stacey.phelps@conehealth.com)
Armes Family Cancer Center Findlay, Ohio
Arnold Palmer Cancer Center Medical Oncology Norwin N. Huntingdon, Pennsylvania Site Public Contact - (haneydl@upmc.edu)
Ascension All Saints Hospital Racine, Wisconsin Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Borgess Cancer Center Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Ascension Calumet Hospital Chilton, Wisconsin Site Public Contact - (AWRI.inquiry@ascension.org)
Ascension Columbia Saint Mary's Hospital - Milwaukee Milwaukee, Wisconsin Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Columbia Saint Mary's Hospital Ozaukee Mequon, Wisconsin Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Medical Group Southeast Wisconsin - Mayfair Road Wauwatosa, Wisconsin Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Mercy Hospital Oshkosh, Wisconsin Site Public Contact - (AWRI.inquiry@ascension.org)
Ascension Providence Hospitals - Novi Novi, Michigan Site Public Contact - (karen.fife@ascension.org)
Ascension Providence Hospitals - Southfield Southfield, Michigan Site Public Contact - (karen.fife@ascension.org)
Ascension Saint Elizabeth Hospital Appleton, Wisconsin Site Public Contact - (AWRI.inquiry@ascension.org)
Ascension Saint Francis - Reiman Cancer Center Franklin, Wisconsin Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Saint Francis Hospital Milwaukee, Wisconsin
Ascension Saint John Hospital Detroit, Michigan Site Public Contact - (karen.forman@ascension.org)
Ascension Saint Joseph Hospital Tawas City, Michigan Site Public Contact - (lori.srebinski@ascension.org)
Ascension Saint Mary's Hospital Saginaw, Michigan Site Public Contact - (lori.srebinski@ascension.org)
Ascension Saint Mary's Hospital Saginaw, Michigan Site Public Contact - (Beth.Knetter@aspirus.org)
Ascension Saint Michael's Hospital Stevens Point, Wisconsin Site Public Contact - (Beth.Knetter@aspirus.org)
Ascension Southeast Wisconsin Hospital - Elmbrook Campus Brookfield, Wisconsin Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Southeast Wisconsin Hospital - Franklin Franklin, Wisconsin
Ascension Southeast Wisconsin Hospital - Saint Joseph Campus Milwaukee, Wisconsin
Ascension Via Christi - Pittsburg Pittsburg, Kansas Site Public Contact - (jennifer.jameson@ascension.org)
Ascension Via Christi Hospitals Wichita Wichita, Kansas Site Public Contact - (research@viachristi.org)
Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids, Wisconsin
Aspirus Medford Hospital Medford, Wisconsin Site Public Contact - (Beth.Knetter@aspirus.org)
Aspirus Regional Cancer Center Wausau, Wisconsin
Asplundh Cancer Pavilion Willow Grove, Pennsylvania Site Public Contact - (ONCTrialNow@jefferson.edu)
Atlanta VA Medical Center Decatur, Georgia
Atlantic Health Sciences Corporation-Saint John Regional Hospital Saint John, New Brunswick
Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Augusta Oncology Associates PC-D'Antignac Augusta, Georgia
Augusta Oncology Associates PC-Wheeler Augusta, Georgia
Aultman Alliance Community Hospital Alliance, Ohio
Aultman Health Foundation Canton, Ohio Site Public Contact - (ClinicalReserachDept@aultman.com)
Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora BayCare Medical Center Green Bay, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Grafton Grafton, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Kenosha South Kenosha, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Racine Racine, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Health Care Germantown Health Center Germantown, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Medical Center in Summit Summit, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Saint Luke's Medical Center Milwaukee, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Saint Luke's South Shore Cudahy, Wisconsin
Aurora Sinai Medical Center Milwaukee, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora West Allis Medical Center West Allis, Wisconsin Site Public Contact - (ncorp@aurora.org)
Avera Cancer Institute Sioux Falls, South Dakota Site Public Contact - (OncRegulatory@avera.org)
Avera Cancer Institute at Yankton Yankton, South Dakota Site Public Contact - (OncRegulatory@avera.org)
Avera Cancer Institute-Aberdeen Aberdeen, South Dakota Site Public Contact - (oncregulatory@avera.org)
BCCA-Vancouver Cancer Centre Vancouver, British Columbia
BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri
Ballad Health Cancer Care - Kingsport Kingsport, Tennessee Site Public Contact - (Justin.reynolds@balladhealth.org)
Banner MD Anderson Cancer Center Gilbert, Arizona
Banner McKee Medical Center Loveland, Colorado Site Public Contact - (BMDACCResearchCOMailbox@bannerhealth.com)
Banner North Colorado Medical Center Greeley, Colorado Site Public Contact - (BMDACCResearchCOMailbox@bannerhealth.com)
Banner-University Medical Center Phoenix Phoenix, Arizona Site Public Contact - (BannerResearch@bannerhealth.com)
Baptist Cancer Center-Grenada Grenada, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Health Corbin Corbin, Kentucky
Baptist Health Lexington Lexington, Kentucky
Baptist Health Louisville Louisville, Kentucky Site Public Contact - (Cbcresearch@bhsi.com)
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)
Bay Area Breast Surgeons Inc Emeryville, California
Bay Area Hospital Coos Bay, Oregon
Bay Area Tumor Institute Oakland, California
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas Site Public Contact - (burton@bcm.edu)
Beaufort Memorial Hospital Beaufort, South Carolina Site Public Contact - (kwade@bmhsc.org)
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)
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
Bethesda North Hospital Cincinnati, Ohio
Beverly Hospital Beverly, Massachusetts
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
Boca Raton Regional Hospital Boca Raton, Florida
Bon Secours Cancer Institute at Reynolds Crossing Richmond, Virginia Site Public Contact - (Anne_caramella@bshsi.org)
Bon Secours DePaul Medical Center Norfolk, Virginia
Bon Secours Health Center at Harbour View Suffolk, Virginia
Bon Secours Maryview Medical Center Portsmouth, Virginia
Bon Secours Memorial Regional Medical Center Mechanicsville, Virginia Site Public Contact - (anne_carmellat@bshsi.org)
Bon Secours Saint Francis Medical Center Midlothian, Virginia Site Public Contact - (anne_carmellat@bshsi.org)
Bon Secours Saint Mary's Hospital Richmond, Virginia Site Public Contact - (anne_carmellat@bshsi.org)
Bon Secours Westchester Emergency Center Midlothian, Virginia
Boston Medical Center Boston, Massachusetts
Boulder Community Foothills Hospital Boulder, Colorado
Bozeman Health Deaconess Hospital Bozeman, Montana Site Public Contact - (mccinfo@mtcancer.org)
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)
Bryn Mawr Hospital Bryn Mawr, Pennsylvania Site Public Contact - (turzoe@mlhs.org)
CHI Health Good Samaritan Kearney, Nebraska
CHI Saint Vincent Cancer Center Hot Springs Hot Springs, Arkansas
CHU de Quebec-Hopital du Saint-Sacrement (HSS) Québec, Quebec Site Public Contact - (jbegin@uresp.ulaval.ca)
CTCA at Southeastern Regional Medical Center Newnan, Georgia
California Pacific Medical Center-Pacific Campus San Francisco, California Site Public Contact - (NCIclinicaltrials@sutterhealth.org)
Cambridge Medical Center Cambridge, Minnesota
Cancer Care Associates of York York, Pennsylvania
Cancer Care Center of O'Fallon O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Care Specialists of Illinois - Decatur Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Care and Hematology-Fort Collins Fort Collins, Colorado Site Public Contact - (protocols@AllianceNCTN.org)
Cancer Center at Saint Joseph's Phoenix, Arizona
Cancer Center of Colorado at Sloan's Lake Denver, Colorado
Cancer Center of Kansas - Chanute Chanute, Kansas Site Public Contact - (research@viachristi.org)
Cancer Center of Kansas - Dodge City Dodge City, Kansas Site Public Contact - (research@viachristi.org)
Cancer Center of Kansas - El Dorado El Dorado, Kansas Site Public Contact - (research@viachristi.org)
Cancer Center of Kansas - McPherson McPherson, Kansas
Cancer Center of Kansas - Newton Newton, Kansas Site Public Contact - (research@viachristi.org)
Cancer Center of Kansas - Parsons Parsons, Kansas Site Public Contact - (research@viachristi.org)
Cancer Center of Kansas - Pratt Pratt, Kansas Site Public Contact - (research@viachristi.org)
Cancer Center of Kansas - Salina Salina, Kansas Site Public Contact - (research@viachristi.org)
Cancer Center of Kansas - Wellington Wellington, Kansas Site Public Contact - (research@viachristi.org)
Cancer Center of Kansas - Wichita Wichita, Kansas Site Public Contact - (research@viachristi.org)
Cancer Center of Kansas - Winfield Winfield, Kansas Site Public Contact - (research@viachristi.org)
Cancer Center of Kansas-Independence Independence, Kansas Site Public Contact - (research@viachristi.org)
Cancer Center of Kansas-Kingman Kingman, Kansas Site Public Contact - (research@viachristi.org)
Cancer Center of Kansas-Liberal Liberal, Kansas Site Public Contact - (research@viachristi.org)
Cancer Center of Kansas-Manhattan Manhattan, Kansas
Cancer Center of Kansas-Wichita Medical Arts Tower Wichita, Kansas Site Public Contact - (research@viachristi.org)
Cancer Center of Western Wisconsin New Richmond, Wisconsin
Cancer Center-Metro Medical Center Bayamon Bayamón,
Cancer Centers of Southwest Oklahoma Research Lawton, Oklahoma
Cancer Specialists of Tidewater Limited Chesapeake, Virginia Site Public Contact - (casey.morris@rivhs.com)
Cancer Specialists of Tidewater-Suffolk Suffolk, Virginia Site Public Contact - (casey.morris@rivhs.com)
Cancer and Blood Specialists-Henderson Henderson, Nevada
Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan Site Public Contact - (connie.szczepanek@crcwm.org)
Cape Cod Hospital Hyannis, Massachusetts
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)
Carlisle Regional Cancer Center Carlisle, Pennsylvania Site Public Contact - (protocols@AllianceNCTN.org)
Caro Cancer Center Caro, Michigan
CaroMont Regional Medical Center Gastonia, North Carolina Site Public Contact - (tammy.cozad@caromonthealth.org)
Carson Tahoe Regional Medical Center Carson City, Nevada
Cedars Sinai Medical Center Los Angeles, California
Centerpoint Medical Center LLC Independence, Missouri Site Public Contact - (aroland@kccop.org)
Centra Alan B Pearson Regional Cancer Center Lynchburg, Virginia Site Public Contact - (Kevin.Patel@centrahealth.com)
Central Care Cancer Center - Bolivar Bolivar, Missouri
Central Care Cancer Center - Garden City Garden City, Kansas Site Public Contact - (aroland@kccop.org)
Central Care Cancer Center - Great Bend Great Bend, Kansas
Central Ohio Breast and Endocrine Surgery Gahanna, Ohio
Centralia Oncology Clinic Centralia, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Centro Comprensivo de Cancer de UPR San Juan, Site Public Contact - (ctsucontact@westat.com)
Chambersburg Hospital Chambersburg, Pennsylvania
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 Comprehensive Cancer Center Duarte, California Site Public Contact - (becomingapatient@coh.org)
City of Hope Newport Beach Newport 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
Clackamas Radiation Oncology Center Clackamas, Oregon
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 Dublin, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Columbus Oncology and Hematology Associates Inc Columbus, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Commonwealth Cancer Center-Corbin Corbin, Kentucky
Community Cancer Center East Indianapolis, Indiana Site Public Contact - (lcheri@ecommunity.com)
Community Cancer Center North Indianapolis, Indiana Site Public Contact - (lcheri@ecommunity.com)
Community Cancer Center South Indianapolis, Indiana Site Public Contact - (lcheri@ecommunity.com)
Community Cancer Institute Clovis, California
Community Hospital of Anaconda Anaconda, Montana Site Public Contact - (mccinfo@mtcancer.org)
Community Howard Regional Health Kokomo, Indiana Site Public Contact - (oncology@communityhoward.org)
Community Medical Center Toms River, New Jersey Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Toms River, New Jersey Site Public Contact - (Lennette.Gonzales@rwjbh.org)
Community Medical Center Toms River, New Jersey Site Public Contact - (HemonCCTrials@geisinger.edu)
Comprehensive Cancer Centers of Nevada Las Vegas, Nevada
Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas, Nevada
Comprehensive Cancer Centers of Nevada - Henderson Henderson, Nevada
Comprehensive Cancer Centers of Nevada - Northwest Las Vegas, Nevada
Comprehensive Cancer Centers of Nevada - Town Center Las Vegas, Nevada
Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson, Nevada
Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson, Nevada
Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas, Nevada
Condell Memorial Hospital Libertyville, Illinois Site Public Contact - (advocateresearch@advocatehealth.com)
Cone Health Cancer Center Greensboro, North Carolina Site Public Contact - (stacey.phelps@conehealth.com)
Cone Health Cancer Center at Alamance Regional Burlington, North Carolina Site Public Contact - (stacey.phelps@conehealth.com)
Cone Health Cancer Center at Asheboro Asheboro, North Carolina
Cone Health Cancer Center at Drawbridge Parkway Greensboro, North Carolina Site Public Contact - (stacey.phelps@conehealth.com)
Cone Heath Cancer Center at Mebane Mebane, North Carolina
Contra Costa Regional Medical Center Martinez, California
Cookeville Regional Medical Center Cookeville, Tennessee
Cooper Hospital University Medical Center Camden, New Jersey
Corewell Health Beaumont Troy Hospital Troy, Michigan
Corewell Health Dearborn Hospital Dearborn, Michigan
Corewell Health Farmington Hills Hospital Farmington Hills, Michigan
Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan
Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Reed City Hospital Reed City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health William Beaumont University Hospital Royal Oak, Michigan
CoxHealth South Hospital Springfield, Missouri
Creighton University Medical Center Omaha, Nebraska
Crossroads Cancer Center Effingham, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Crozer Regional Cancer Center at Brinton Lake Glen Mills, Pennsylvania
Crozer-Chester Medical Center Upland, Pennsylvania Site Public Contact - (colleen.kennedy@crozer.org)
Crozer-Keystone Regional Cancer Center at Broomall Broomall, Pennsylvania Site Public Contact - (Jolene.garney@crozer.org)
Dana-Farber Cancer Institute Boston, Massachusetts
Dana-Farber Cancer Institute at Foxborough Foxborough, Massachusetts
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Milford, Massachusetts
Dana-Farber/Brigham and Women's Cancer Center at South Shore South Weymouth, Massachusetts
Danbury Hospital Danbury, Connecticut
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 County Memorial Hospital Drexel Hill, Pennsylvania Site Public Contact - (jolene.garney@crozer.org)
Delaware Health Center-Grady Cancer Center Delaware, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Delbert Day Cancer Institute at PCRMC Rolla, Missouri
Desert Regional Medical Center Palm Springs, California
Desert West Surgery Las Vegas, Nevada
Dickstein Cancer Treatment Center White Plains, New York Site Public Contact - (mcortese@wphospital.org)
Divine Providence Hospital Williamsport, Pennsylvania Site Public Contact - (protocols@AllianceNCTN.org)
Doctor's Hospital of Laredo Laredo, Texas
Doctors Cancer Center Manatí,
Doctors Hospital Columbus, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Drexel Town Square Health Center Oak Creek, Wisconsin
Dublin Methodist Hospital Dublin, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Duke University Medical Center Durham, North Carolina
Duke Women's Cancer Care Raleigh Raleigh, North Carolina
Duluth Clinic Ashland Ashland, Wisconsin Site Public Contact - (CancerTrials@EssentiaHealth.org)
ECU Health Oncology Kinston Kinston, North Carolina Site Public Contact - (research@ecuhealth.org)
East Jefferson General Hospital Metairie, Louisiana
Eden Hospital Medical Center Castro Valley, California
Edwards Comprehensive Cancer Center Huntington, West Virginia Site Public Contact - (Christina.Cole@chhi.org)
Eisenhower Medical Center Rancho Mirage, California
Emory Saint Joseph's Hospital Atlanta, Georgia
Emory University Hospital Midtown Atlanta, Georgia
Emory University Hospital/Winship Cancer Institute Atlanta, Georgia
Englewood Hospital and Medical Center Englewood, New Jersey
Ephrata Cancer Center Ephrata, Pennsylvania
Ephrata Community Hospital Ephrata, Pennsylvania
Epic Care Cyberknife Center Walnut Creek, California
Epic Care Partners in Cancer Care Emeryville, California
Epic Care-Dublin Dublin, California
Essentia Health - Deer River Clinic Deer River, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - Fosston Fosston, Minnesota
Essentia Health - Jamestown Clinic Jamestown, North Dakota
Essentia Health - Park Rapids Park Rapids, Minnesota
Essentia Health Cancer Center Duluth, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Cancer Center-South University Clinic Fargo, North Dakota
Essentia Health Hibbing Clinic Hibbing, Minnesota
Essentia Health Saint Joseph's Medical Center Brainerd, Minnesota
Essentia Health Saint Mary's - Detroit Lakes Clinic Detroit Lakes, Minnesota
Essentia Health Saint Mary's Medical Center Duluth, Minnesota
Essentia Health Sandstone Sandstone, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Virginia Clinic Virginia, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Fairbanks Memorial Hospital Fairbanks, Alaska Site Public Contact - (Veronica.Stevenson@foundationhealth.org)
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 Site Public Contact - (mmcorc@healthpartners.com)
FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst, North Carolina Site Public Contact - (jcwilliams@firsthealth.org)
Flaget Memorial Hospital Bardstown, Kentucky
Fox Chase Cancer Center Philadelphia, Pennsylvania
Fox Chase Cancer Center - East Norriton Hospital Outpatient Center East Norriton, Pennsylvania
Franciscan Health Indianapolis Indianapolis, Indiana
Franciscan Health Mooresville Mooresville, Indiana
Franciscan Research Center-Northwest Medical Plaza Tacoma, Washington
Franciscan Saint Elizabeth Health - Lafayette East Lafayette, Indiana
Freeman Health System Joplin, Missouri
Freeman Physician Group of Pittsburg Pittsburg, Kansas Site Public Contact - (BNMathew@freemanhealth.com)
Froedtert Menomonee Falls Hospital Menomonee Falls, Wisconsin
Froedtert West Bend Hospital/Kraemer Cancer Center West Bend, Wisconsin
Geisinger Cancer Services-Pottsville Pottsville, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Medical Center Danville, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Medical Center-Cancer Center Hazleton Hazleton, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Medical Oncology-Lewisburg Lewisburg, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Genesee Cancer and Blood Disease Treatment Center Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Genesee Hematology Oncology PC Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Genesis Cancer Care Institute Davenport, Iowa Site Public Contact - (turnerk@genesishealth.com)
Genesis Cancer Center - Silvis Silvis, Illinois Site Public Contact - (turnerk@genesishealth.com)
Genesis Healthcare System Cancer Care Center Zanesville, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Genesis Medical Center - East Campus Davenport, Iowa Site Public Contact - (turnerk@genesishealth.com)
GenesisCare USA - Fort Apache Las Vegas, Nevada
GenesisCare USA - Henderson Henderson, Nevada
GenesisCare USA - Las Vegas Las Vegas, Nevada
GenesisCare USA - Vegas Tenaya Las Vegas, Nevada
Genesys Hurley Cancer Institute Flint, Michigan Site Public Contact - (wstrong@ghci.org)
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)
Glens Falls Hospital Glens Falls, New York
Good Samaritan Hospital - Cincinnati Cincinnati, Ohio Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Good Samaritan Medical Center West Palm Beach, Florida
Good Samaritan Regional Health Center Mount Vernon, Illinois
Good Samaritan University Hospital West Islip, New York
Grady Health System Atlanta, Georgia
Grady Memorial Hospital Atlanta, Georgia Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Grand Valley Oncology Grand Junction, Colorado Site Public Contact - (gvoclinicaltrials@gjhosp.org)
Grant Medical Center Columbus, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Great Falls Clinic Great Falls, Montana
Great Lakes Cancer Management Specialists-Doctors Park East China Township, Michigan
Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb, Michigan
Great Lakes Cancer Management Specialists-Macomb Professional Building Warren, Michigan
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods, Michigan
Greater Baltimore Medical Center Baltimore, Maryland
Greater Dayton Cancer Center Kettering, Ohio
Greater Regional Medical Center Creston, Iowa Site Public Contact - (cancerresearch@mercydesmoines.org)
Gundersen Lutheran Medical Center La Crosse, Wisconsin Site Public Contact - (cancerctr@gundersenhealth.org)
Guthrie Medical Group PC-Robert Packer Hospital Sayre, Pennsylvania
HSHS Sacred Heart Hospital Eau Claire, Wisconsin Site Public Contact - (ewd_research_admin@hshs.org)
Hackensack University Medical Center Hackensack, New Jersey
Harold Alfond Center for Cancer Care Augusta, Maine
Harrison HealthPartners Hematology and Oncology-Bremerton Bremerton, Washington Site Public Contact - (clinicaltrials@sfmc-gi.org)
Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo, Washington
Hartford HealthCare - Saint Vincent's Medical Center Bridgeport, Connecticut
Hartford Hospital Hartford, Connecticut
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)
Hawaii Cancer Care Inc-Liliha Honolulu, Hawaii
HaysMed Hays, Kansas
Health Partners Inc Minneapolis, Minnesota
Heartland Oncology and Hematology LLP Council Bluffs, Iowa
Heartland Regional Medical Center Saint Joseph, Missouri
Helen F Graham Cancer Center Newark, Delaware Site Public Contact - (lbarone@christianacare.org)
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 Associates of Central New York-Onondaga Hill Syracuse, New York
Hematology Oncology Consultants-Clarkston Clarkston, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Hennepin County Medical Center Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Hickman Cancer Center Adrian, Michigan
Highline Medical Center-Main Campus Burien, Washington
Holy Cross Hospital Fort Lauderdale, Florida Site Public Contact - (eileen.georgi@holy-cross.com)
Holy Name Hospital Teaneck, New Jersey
Hope Cancer Care of Nevada Las Vegas, Nevada
Hope Cancer Care of Nevada-Pahrump Pahrump, Nevada
Hope Cancer Center Pontiac, Michigan
Hope Cancer Clinic Livonia, Michigan
Houston Methodist Hospital Houston, Texas
Houston Methodist Saint John Hospital Nassau Bay, Texas Site Public Contact - (protocols@AllianceNCTN.org)
Houston Methodist San Jacinto Hospital Baytown, Texas
Houston Methodist Sugar Land Hospital Sugar Land, Texas
Houston Methodist The Woodlands Hospital The Woodlands, Texas Site Public Contact - (hmthewoodlands@houstonmethodist.org)
Houston Methodist West Hospital Houston, Texas
Huntington Memorial Hospital Pasadena, California
Hurley Medical Center Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Huron Gastroenterology PC Ypsilanti, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
IRMC Cancer Center Indiana, Pennsylvania Site Public Contact - (haneydl@upmc.edu)
IU Health North Hospital Carmel, Indiana Site Public Contact - (iutrials@iu.edu)
Idaho Urologic Institute-Meridian Meridian, Idaho
Illinois CancerCare - Washington Washington, Illinois
Illinois CancerCare-Bloomington Bloomington, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
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 Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Peoria Peoria, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
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)
Inova Fair Oaks Hospital Fairfax, Virginia Site Public Contact - (Stephanie.VanBebber@inova.org)
Inova Schar Cancer Institute Fairfax, Virginia Site Public Contact - (Stephanie.VanBebber@inova.org)
Integris Cancer Institute of Oklahoma Oklahoma City, Oklahoma
Integris Southwest Medical Center Oklahoma City, Oklahoma
Iowa Cancer Specialists Davenport, Iowa Site Public Contact - (turnerk@genesishealth.com)
Iowa Lutheran Hospital Des Moines, Iowa
Iowa Methodist Medical Center Des Moines, Iowa
Island Urology Honolulu, Hawaii
Island Urology-Hilo Hilo, Hawaii
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 Hospital Louisville, Kentucky
Jewish Hospital Medical Center South Shepherdsville, Kentucky
John H Stroger Jr Hospital of Cook County Chicago, Illinois
John Muir Medical Center-Concord Concord, California
John Muir Medical Center-Walnut Creek Walnut Creek, California Site Public Contact - (clinicalresearch@johnmuirhealth.com)
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 - Kensington Medical Center Kensington, Maryland
Kaiser Permanente - Largo Medical Center Largo, Maryland
Kaiser Permanente Downtown Commons Sacramento, California Site Public Contact - (kpoct@kp.org)
Kaiser Permanente Dublin Dublin, California
Kaiser Permanente Lutherville - Timonium Medical Center Lutherville, Maryland
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 Tysons Corner Medical Center McLean, Virginia
Kaiser Permanente-Burke Medical Center Burke, Virginia Site Public Contact - (Diane.Fisher@nsmtp.kp.org)
Kaiser Permanente-Capitol Hill Medical Center Washington D.C., District of Columbia
Kaiser Permanente-Caton Hill Medical Center Woodbridge, Virginia Site Public Contact - (Leslie.K.Greenberg@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-Gaithersburg Medical Center Gaithersburg, Maryland
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 Permanente-Woodlawn Medical Center Baltimore, Maryland
Kaiser San Rafael-Gallinas San Rafael, California Site Public Contact - (Kpoct@kp.org)
Kalispell Regional Medical Center Kalispell, Montana Site Public Contact - (mccinfo@mtcancer.org)
Kapiolani Medical Center for Women and Children Honolulu, Hawaii
Katmai Oncology Group Anchorage, Alaska
Keck Medical Center of USC Pasadena Pasadena, California
Keck Medicine of USC Koreatown Los Angeles, California
Kent Hospital Warwick, Rhode Island
Kettering Medical Center Kettering, Ohio
King's Daughter's Medical Center Ashland, Kentucky
Kingman Regional Medical Center Kingman, Arizona Site Public Contact - (research@sncrf.org)
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)
Kuakini Medical Center Honolulu, Hawaii
LSU Health Sciences Center at Shreveport Shreveport, Louisiana
Lafayette Family Cancer Center-EMMC Brewer, Maine
Lahey Hospital and Medical Center Burlington, Massachusetts Site Public Contact - (lhmc-cancer-clinical-trials@lahey.org)
Lahey Medical Center-Peabody Peabody, Massachusetts Site Public Contact - (lhmc-cancer-clinical-trials@lahey.org)
Lake Region Healthcare Corporation-Cancer Care Fergus Falls, Minnesota
Lakeridge Health Oshawa Oshawa, Ontario
Lakeview Hospital Stillwater, Minnesota
Langlade Hospital and Cancer Center Antigo, Wisconsin Site Public Contact - (Juli.Alford@aspirus.org)
Lankenau Medical Center Wynnewood, Pennsylvania Site Public Contact - (turzoe@mlhs.org)
Las Vegas Cancer Center-Henderson Henderson, Nevada
Las Vegas Cancer Center-Medical Center Las Vegas, Nevada
Las Vegas Prostate Cancer Center Las Vegas, Nevada
Las Vegas Urology - Cathedral Rock Las Vegas, Nevada
Las Vegas Urology - Green Valley Henderson, Nevada
Las Vegas Urology - Pebble Henderson, Nevada
Las Vegas Urology - Pecos Las Vegas, Nevada
Las Vegas Urology - Smoke Ranch Las Vegas, Nevada
Las Vegas Urology - Sunset Las Vegas, Nevada
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York Site Public Contact - (CancerTrials@nyulangone.org)
Lawrence Memorial Hospital Lawrence, Kansas Site Public Contact - (Stephanie.Norris@LMH.ORG)
Legacy Cancer Institute Medical Oncology and Day Treatment Vancouver, Washington Site Public Contact - (oncologyresearch@lhs.org)
Legacy Good Samaritan Hospital and Medical Center Portland, Oregon Site Public Contact - (cancer@lhs.org)
Legacy Meridian Park Hospital Tualatin, Oregon
Legacy Mount Hood Medical Center Gresham, Oregon
Legacy Salmon Creek Hospital Vancouver, Washington
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
Lenox Hill Hospital New York, New York
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah, Georgia Site Public Contact - (underberga@sjchs.org)
Lexington Medical Center West Columbia, South Carolina Site Public Contact - (research@lexhhealth.org)
Licking Memorial Hospital Newark, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Littleton Adventist Hospital Littleton, Colorado
London Regional Cancer Program London, Ontario
Longmont United Hospital Longmont, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Los Angeles General Medical Center Los Angeles, California Site Public Contact - (uscnorrisinfo@med.usc.edu)
Louisiana State University Health Science Center New Orleans, Louisiana
Lowell General Hospital Lowell, Massachusetts Site Public Contact - (ghincks@lowellgeneral.org)
Luminis Health Anne Arundel Medical Center Annapolis, Maryland Site Public Contact - (research@luminishealth.org)
Lyndon Baines Johnson General Hospital Houston, Texas
M D Anderson Cancer Center Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
MD Anderson League City League City, Texas
MD Anderson West Houston Houston, Texas
MD Anderson in Sugar Land Sugar Land, Texas
MD Anderson in The Woodlands Conroe, Texas
MGC Hematology Oncology-Union Union, South Carolina Site Public Contact - (kmertz-rivera@gibbscc.org)
MU Health - University Hospital/Ellis Fischel Cancer Center Columbia, Missouri
MU Health Care Goldschmidt Cancer Center Jefferson City, Missouri
Macomb Hematology Oncology PC Warren, Michigan
Main Line Health Center-Collegeville Collegeville, Pennsylvania
Main Line Health Center-Exton Exton, Pennsylvania
Maine Center for Cancer Medicine-Kennebunk Kennebunk, Maine
Maine Center for Cancer Medicine-Scarborough Scarborough, Maine Site Public Contact - (research@newecs.org)
Maine Center for Cancer Medicine-Topsham Topsham, Maine Site Public Contact - (research@newecs.org)
Maine Medical Partners - South Portland South Portland, Maine Site Public Contact - (ClinicalResearch@mmc.org)
MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford Biddeford, Maine Site Public Contact - (LLemire@mmc.org)
MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford Sanford, Maine Site Public Contact - (LLemire@mmc.org)
Manhattan Eye Ear and Throat Hospital New York, New York
Marietta Memorial Hospital Marietta, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Marshfield Clinic-Minocqua Center 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
Matthews Radiation Oncology Center Matthews, North Carolina
Mayo Clinic in Florida Jacksonville, Florida
Mayo Clinic in Rochester Rochester, Minnesota
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
McLeod Regional Medical Center Florence, South Carolina
Mease Countryside Hospital Safety Harbor, Florida Site Public Contact - (research.cto@baycare.org)
MedStar Franklin Square Medical Center/Weinberg Cancer Institute Baltimore, Maryland
MedStar Georgetown University Hospital Washington D.C., District of Columbia
MedStar Good Samaritan Hospital Baltimore, Maryland Site Public Contact - (Barbara.rector@medstar.net)
MedStar Montgomery Medical Center Olney, Maryland
Medical Center of the Rockies Loveland, Colorado
Medical College of Wisconsin Milwaukee, Wisconsin
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)
Medstar Washington Hospital Center Washington D.C., District of Columbia
Memorial Health University Medical Center Savannah, Georgia Site Public Contact - (Lorraine.OHara@hcahealthcare.com)
Memorial Hospital Marysville, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Memorial Hospital East Shiloh, Illinois Site Public Contact - (dschwab@wustl.edu)
Memorial Hospital North Colorado Springs, Colorado
Memorial Hospital West Pembroke Pines, Florida
Memorial Hospital of Carbondale Carbondale, Illinois
Memorial Hospital of South Bend South Bend, Indiana
Memorial Medical Center Modesto, California Site Public Contact - (NCIclinicaltrials@sutterhealth.org)
Memorial Medical Center Modesto, California Site Public Contact - (pallante.beth@mhsil.com)
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida
Menorah Medical Center Overland Park, Kansas Site Public Contact - (aroland@kccop.org)
Mercy Cancer Center - Carmichael Carmichael, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mercy Cancer Center - Elk Grove Elk Grove, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mercy Cancer Center - Rocklin Rocklin, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mercy Cancer Center - Sacramento Sacramento, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mercy Cancer Center-West Lakes Clive, Iowa Site Public Contact - (cancerresearch@mercydesmoines.org)
Mercy Clinic-Rolla-Cancer and Hematology Rolla, Missouri
Mercy Health - Saint Anne Hospital Toledo, Ohio
Mercy Health - Saint Vincent Hospital Toledo, Ohio
Mercy Hematology and Oncology Associates Inc Canton, Ohio
Mercy Hospital Coon Rapids, Minnesota
Mercy Hospital Coon Rapids, Minnesota 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 Medical Center Durango, Colorado
Mercy Medical Center - Des Moines Des Moines, Iowa Site Public Contact - (cancerresearch@mercydesmoines.org)
Mercy Medical Center-West Lakes West Des Moines, Iowa Site Public Contact - (cancerresearch@mercydesmoines.org)
Mercy San Juan Medical Center Carmichael, California Site Public Contact - (OncologyResearch@DignityHealth.org)
Mercyhealth Hospital and Cancer Center - Janesville Janesville, Wisconsin Site Public Contact - (oncologyclinicaltrials@mhemail.org)
Methodist Jennie Edmundson Hospital Council Bluffs, Iowa Site Public Contact - (kathryn.bartz@nmhs.org)
Methodist Medical Center of Illinois Peoria, Illinois
Methodist West Hospital West Des Moines, Iowa
Methodist Willowbrook Hospital Houston, Texas Site Public Contact - (protocols@AllianceNCTN.org)
Miami Valley Cancer Care and Infusion Greenville, Ohio
Miami Valley Hospital Dayton, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Miami Valley Hospital North Dayton, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Miami Valley Hospital South Centerville, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Michigan Breast Specialists-Grosse Pointe Woods Grosse Pointe Woods, Michigan
Michigan Breast Specialists-Macomb Township Macomb, Michigan
Michigan Breast Specialists-Warren Warren, Michigan
Michigan Healthcare Professionals Pontiac Pontiac, Michigan Site Public Contact - (Emily.Crofts@trinity-health.org)
Midlands Community Hospital Papillion, Nebraska
Midstate Medical Center Meriden, Connecticut
Miller-Dwan Hospital Duluth, Minnesota
Minnesota Oncology - Burnsville Burnsville, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota
Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota
Mission Cancer and Blood - Ankeny Ankeny, Iowa
Mission Cancer and Blood - Des Moines Des Moines, Iowa
Mission Cancer and Blood - Laurel Des Moines, Iowa
Mission Cancer and Blood - West Des Moines Clive, Iowa
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
Mobile Infirmary Medical Center Mobile, Alabama
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
Morristown Medical Center Morristown, New Jersey
Morton Plant Hospital Clearwater, Florida
Mount Carmel East Hospital Columbus, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Mount Carmel Grove City Hospital Grove City, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Mount Carmel Health Center West Columbus, Ohio
Mount Sinai Chelsea New York, New York Site Public Contact - (CCTO@mssm.edu)
Mount Sinai Comprehensive Cancer Center at Aventura Aventura, Florida Site Public Contact - (yenrique@msmc.com)
Mount Sinai Hospital New York, New York Site Public Contact - (CCTO@mssm.edu)
Mount Sinai Hospital Medical Center Chicago, Illinois Site Public Contact - (suhi@sinai.org)
Mount Sinai Medical Center Miami Beach, Florida Site Public Contact - (yenrique@msmc.com)
Mount Sinai West New York, New York Site Public Contact - (CCTO@mssm.edu)
Mountain Blue Cancer Care Center - Swedish Englewood, Colorado
MultiCare Auburn Medical Center Auburn, Washington Site Public Contact - (research@multicare.org)
MultiCare Deaconess Cancer and Blood Specialty Center - Downtown Spokane, Washington Site Public Contact - (research@multicare.org)
MultiCare Deaconess Cancer and Blood Specialty Center - North Spokane, Washington Site Public Contact - (research@multicare.org)
MultiCare Gig Harbor Medical Park Gig Harbor, Washington Site Public Contact - (research@multicare.org)
MultiCare Good Samaritan Hospital Puyallup, Washington Site Public Contact - (research@multicare.org)
MultiCare Tacoma General Hospital Tacoma, Washington Site Public Contact - (research@multicare.org)
Munson Medical Center Traverse City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
MyMichigan Medical Center Midland Midland, Michigan
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 Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu)
NYU Langone Hospital - Long Island Mineola, New York Site Public Contact - (cancertrials@nyulangone.org)
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
Nebraska Cancer Specialists/Oncology Hematology West PC - MECC Omaha, Nebraska
Nebraska Medicine-Bellevue Bellevue, Nebraska
Nebraska Medicine-Village Pointe Omaha, Nebraska
Nebraska Methodist Hospital Omaha, Nebraska
New Hampshire Oncology Hematology PA-Concord Concord, New Hampshire
New Ulm Medical Center New Ulm, Minnesota
Newark Beth Israel Medical Center Newark, New Jersey Site Public Contact - (Christine.Kosmides@rwjbh.org)
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 Site Public Contact - (mmcorc@healthpartners.com)
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington
NorthShore University HealthSystem-Evanston Hospital Evanston, Illinois
NorthShore University HealthSystem-Glenbrook Hospital Glenview, Illinois
NorthShore University HealthSystem-Highland Park Hospital Highland Park, Illinois
Northern Westchester Hospital Mount Kisco, New York Site Public Contact - (AMellor@northwell.edu)
Northside Hospital Atlanta, Georgia Site Public Contact - (ClinicalTrials@northside.com)
Northside Hospital - Duluth Duluth, Georgia Site Public Contact - (Clinical.trials@northside.com)
Northside Hospital - Gwinnett Lawrenceville, Georgia Site Public Contact - (Clinical.trials@northside.com)
Northwell Health Imbert Cancer Center Bay Shore, New York
Northwell Health/Center for Advanced Medicine Lake Success, New York
Northwest Community Hospital Arlington Heights, Illinois
Northwest Medical Specialties PLLC Tacoma, Washington
Northwest Wisconsin Cancer Center Ashland, Wisconsin
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)
Norwalk Hospital Norwalk, Connecticut Site Public Contact - (jennifer.long@norwalkhealth.org)
Novant Health Breast Surgery - Greensboro Greensboro, North Carolina
Novant Health Cancer Institute - Huntersville Huntersville, North Carolina Site Public Contact - (kashah@novanthealth.org)
Novant Health Cancer Institute - Kernersville Kernersville, North Carolina Site Public Contact - (asmarrs@novanthealth.org)
Novant Health Cancer Institute - Matthews Matthews, North Carolina Site Public Contact - (kashah@novanthealth.org)
Novant Health Cancer Institute - Mooresville Mooresville, North Carolina Site Public Contact - (kashah@novanthealth.org)
Novant Health Cancer Institute - Mount Airy Mount Airy, North Carolina Site Public Contact - (asmarrs@novanthealth.org)
Novant Health Cancer Institute - Rowan Salisbury, North Carolina
Novant Health Cancer Institute - Statesville Statesville, North Carolina Site Public Contact - (pjordan@novanthealth.org)
Novant Health Cancer Institute - Thomasville Thomasville, North Carolina Site Public Contact - (pjordan@novanthealth.org)
Novant Health Cancer Institute - Wilkesboro North Wilkesboro, 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 Site Public Contact - (kashah@novanthealth.org)
Nyack Hospital Nyack, New York
OSF Saint Anthony Medical Center Rockford, Illinois
OSF Saint Francis Medical Center Peoria, Illinois
OSF Saint Francis Radiation Oncology at Pekin Pekin, Illinois
OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria, Illinois
Odette Cancer Centre- Sunnybrook Health Sciences Centre Toronto, Ontario
Ohio State University Comprehensive Cancer Center Columbus, Ohio Site Public Contact - (Jamesline@osumc.edu)
OhioHealth Mansfield Hospital Mansfield, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
OhioHealth Marion General Hospital Marion, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Olathe Health Cancer Center Olathe, Kansas Site Public Contact - (Jeni.wakefield@olathehealth.org)
Oncology Associates PC Omaha, Nebraska Site Public Contact - (info@oa-oc.com)
Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa
Oncology Hematology Associates Springfield, Missouri Site Public Contact - (protocols@AllianceNCTN.org)
Oncology Hematology Associates of Saginaw Valley PC Saginaw, Michigan Site Public Contact - (lori.srebinski@ascension.org)
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 MountainView Las Vegas, Nevada
OptumCare Cancer Care at Seven Hills Henderson, Nevada Site Public Contact - (research@sncrf.org)
Orion Cancer Care Findlay, Ohio
Orlando Health Cancer Institute Orlando, Florida Site Public Contact - (CancerClinicalTrials@orlandohealth.com)
Overlake Medical Center Bellevue, Washington
Overlook Hospital Summit, New Jersey
PCR Oncology Arroyo Grande, California
PROncology San Juan,
Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo, California
Pacific Gynecology Specialists Seattle, Washington
Pali Momi Medical Center ‘Aiea, Hawaii
Palo Alto Medical Foundation Health Care Palo Alto, California Site Public Contact - (NCIclinicaltrials@sutterhealth.org)
Palo Alto Medical Foundation-Camino Division Mountain View, California Site Public Contact - (NCIclinicaltrials@sutterhealth.org)
Palo Alto Medical Foundation-Fremont Fremont, California Site Public Contact - (NCIclinicaltrials@sutterhealth.org)
Palo Alto Medical Foundation-Gynecologic Oncology Mountain View, California
Palo Alto Medical Foundation-Santa Cruz Santa Cruz, California Site Public Contact - (NCIclinicaltrials@sutterhealth.org)
Palo Alto Medical Foundation-Sunnyvale Sunnyvale, California Site Public Contact - (NCIclinicaltrials@sutterhealth.org)
Paoli Memorial Hospital Paoli, Pennsylvania Site Public Contact - (turzoe@mlhs.org)
Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Parker Adventist Hospital Parker, Colorado
Parkland Health Center - Farmington Farmington, Missouri
Parkland Memorial Hospital Dallas, Texas Site Public Contact - (canceranswerline@UTSouthwestern.edu)
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
Peninsula Cancer Institute-Cancer Specialists of Tidewater Virginia Beach, Virginia Site Public Contact - (casey.morris@rivhs.com)
Peninsula Cancer Institute-Gloucester Gloucester, Virginia Site Public Contact - (casey.morris@rivhs.com)
Peninsula Cancer Institute-Newport News Newport News, Virginia Site Public Contact - (casey.morris@rivhs.com)
Peninsula Cancer Institute-Williamsburg Williamsburg, Virginia Site Public Contact - (casey.morris@rivhs.com)
Penn State Milton S Hershey Medical Center Hershey, Pennsylvania
Penrose-Saint Francis Healthcare Colorado Springs, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Phelps Memorial Hospital Center Sleepy Hollow, New York
Phoebe Putney Memorial Hospital Albany, Georgia Site Public Contact - (ga_cares@augusta.edu)
Phoenixville Hospital Phoenixville, Pennsylvania
Physicians' Clinic of Iowa PC Cedar Rapids, Iowa
Pluta Cancer Center Rochester, New York
Pocono Medical Center East Stroudsburg, Pennsylvania
Porter Adventist Hospital Denver, Colorado
Pottstown Hospital Pottstown, Pennsylvania
Poudre Valley Hospital Fort Collins, Colorado
Premier Blood and Cancer Center Dayton, Ohio
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
Prisma Health Cancer Institute - Easley Easley, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Eastside Greenville, South Carolina
Prisma Health Cancer Institute - Faris Greenville, South Carolina
Prisma Health Cancer Institute - Greer Greer, South Carolina
Prisma Health Cancer Institute - Seneca Seneca, South Carolina
Prisma Health Cancer Institute - Spartanburg Boiling Springs, South Carolina
Prisma Health Greenville Memorial Hospital Greenville, South Carolina
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
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 Medical Foundation - Santa Rosa Santa Rosa, California
Providence Newberg Medical Center Newberg, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Portland Medical Center Portland, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence 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 Santa Rosa Memorial Hospital Santa Rosa, California
Providence Willamette Falls Medical Center Oregon City, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Puerto Rico Hematology Oncology Group Bayamón,
Queen's Cancer Cenrer - POB I Honolulu, Hawaii
Queen's Cancer Center - Kuakini Honolulu, Hawaii
Queen's Cancer Center - Pearlridge ‘Aiea, Hawaii
Queen's Medical Center Honolulu, Hawaii
Queens Hospital Center Jamaica, New York
Radiation Oncology Associates Reno, Nevada
Radiation Oncology Centers of Nevada Central Las Vegas, Nevada
Radiation Oncology Centers of Nevada Southeast Las Vegas, Nevada
Randolph Health Cancer Center Asheboro, North Carolina Site Public Contact - (stacey.phelps@conehealth.com)
Randolph Hospital Asheboro, North Carolina
Reading Hospital West Reading, Pennsylvania
Regions Hospital Saint Paul, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Reid Health Richmond, Indiana
Renown Regional Medical Center Reno, Nevada Site Public Contact - (research@sncrf.org)
Research Medical Center Kansas City, Missouri Site Public Contact - (aroland@kccop.org)
Rex Hematology Oncology Associates-Blue Ridge Raleigh, North Carolina
Rex Hematology Oncology Associates-Cary Cary, North Carolina Site Public Contact - (CancCtrOncologyClinicalResearch@unchealth.unc.edu)
Rex Hematology Oncology Associates-Garner Garner, North Carolina Site Public Contact - (CancCtrOncologyClinicalResearch@unchealth.unc.edu)
Rhode Island Hospital Providence, Rhode Island
Rice Memorial Hospital Willmar, Minnesota
Riddle Memorial Hospital Media, Pennsylvania Site Public Contact - (turzoe@mlhs.org)
Ridgeview Medical Center Waconia, Minnesota
Riverside Methodist Hospital Columbus, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Riverwood Healthcare Center Aitkin, Minnesota
Robert Wood Johnson University Hospital Somerset Somerville, New Jersey Site Public Contact - (Siby.Varughese@rwjbh.org)
Rocky Mountain Cancer Centers - Centennial Centennial, Colorado Site Public Contact - (info@westernstatesncorp.org)
Rocky Mountain Cancer Centers - Swedish Englewood, Colorado
Rocky Mountain Cancer Centers-Aurora Aurora, Colorado Site Public Contact - (info@westernstatesncorp.org)
Rocky Mountain Cancer Centers-Boulder Boulder, Colorado Site Public Contact - (info@westernstatesncorp.org)
Rocky Mountain Cancer Centers-Lakewood Lakewood, Colorado
Rocky Mountain Cancer Centers-Littleton Littleton, Colorado Site Public Contact - (info@westernstatesncorp.org)
Rocky Mountain Cancer Centers-Longmont Longmont, Colorado
Rocky Mountain Cancer Centers-Midtown Denver, Colorado Site Public Contact - (info@westernstatesncorp.org)
Rocky Mountain Cancer Centers-Penrose Colorado Springs, Colorado
Rocky Mountain Cancer Centers-Rose Denver, Colorado Site Public Contact - (info@westernstatesncorp.org)
Rocky Mountain Cancer Centers-Sky Ridge Lone Tree, Colorado Site Public Contact - (info@westernstatesncorp.org)
Rocky Mountain Cancer Centers-Thornton Thornton, Colorado
Rose Medical Center Denver, Colorado
Roswell Park Cancer Institute Buffalo, New York Site Public Contact - (askroswell@roswellpark.org)
Rush - Copley Medical Center Aurora, Illinois Site Public Contact - (Cancer.Research@rushcopley.com)
Rush University Medical Center Chicago, Illinois Site Public Contact - (clinical_trials@rush.edu)
Rush-Copley Healthcare Center Yorkville, Illinois Site Public Contact - (Cancer.Research@rushcopley.com)
Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey
Rutgers New Jersey Medical School Newark, New Jersey
SCL Health Cancer Centers of Colorado - Lutheran Medical Center Golden, Colorado Site Public Contact - (Alan.miller@sclhealth.org)
SCL Health Lutheran Medical Center Wheat Ridge, Colorado
SCL Health Saint Joseph Hospital Denver, Colorado Site Public Contact - (alan.franklin@sclhealth.org)
SIH Cancer Institute Carterville, Illinois Site Public Contact - (clinical.research@sih.net)
Sacred Heart Hospital Pensacola, Florida Site Public Contact - (eebrou@ascension.org)
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 Site Public Contact - (sbenson@iora.org)
Saint Anthony's Health Alton, Illinois
Saint Anthony's Hospital Cancer Care Center St. Petersburg, Florida Site Public Contact - (Mindy.Thacker@baycare.org)
Saint Barnabas Medical Center Livingston, New Jersey Site Public Contact - (joanne.loeb@rwjbh.org)
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 Cancer Center Greenville, South Carolina Site Public Contact - (melissa_beckman@bshsi.org)
Saint Francis Hospital Greenville, South Carolina Site Public Contact - (melissa_beckman@bshsi.org)
Saint Francis Hospital Greenville, South Carolina
Saint Francis Medical Center Cape Girardeau, Missouri Site Public Contact - (sfmc@sfmc.net)
Saint Francis Regional Medical Center Shakopee, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Saint Helena Hospital St. Helena, California
Saint James Community Hospital and Cancer Treatment Center Butte, Montana
Saint John Macomb-Oakland Hospital Warren, Michigan
Saint John's Cancer Institute Santa Monica, California
Saint John's Hospital - Healtheast Maplewood, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Saint Joseph Hospital - Orange Orange, California
Saint Joseph Hospital East Lexington, Kentucky Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Saint 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 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 Joseph's/Candler - Bluffton Campus Bluffton, South Carolina Site Public Contact - (underberga@sjchs.org)
Saint Jude Medical Center Fullerton, California
Saint Louis Cancer and Breast Institute-Ballwin Ballwin, Missouri
Saint Louis Cancer and Breast Institute-South City St Louis, Missouri
Saint Luke's Cancer Institute - Boise Boise, Idaho
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 East - Lee's Summit Lee's Summit, Missouri Site Public Contact - (aroland@kccop.org)
Saint Luke's Hospital Chesterfield, Missouri
Saint Luke's Hospital of Duluth Duluth, Minnesota Site Public Contact - (kdean@slhduluth.com)
Saint Luke's Hospital of Kansas City Kansas City, Missouri Site Public Contact - (aroland@kccop.org)
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 Site Public Contact - (lori.srebinski@ascension.org)
Saint Mary's Regional Medical Center Reno, Nevada
Saint Michael Cancer Center Silverdale, Washington
Saint Michael's Hospital Toronto, Ontario
Saint Patrick Hospital - Community Hospital Missoula, Montana Site Public Contact - (amy.hanneman@providence.org)
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 Site Public Contact - (ewd_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin Site Public Contact - (ewd_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin Site Public Contact - (ewd_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin Site Public Contact - (ewd_research_admin@hshs.org)
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)
Salinas Valley Memorial Salinas, California Site Public Contact - (tnielsen2@svmh.com)
San Juan City Hospital San Juan,
San Juan Community Oncology Group San Juan,
Sanford Bismarck Medical Center Bismarck, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford Broadway Medical Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota Site Public Contact - (OncologyClinicTrialsSF@sanfordhealth.org)
Sanford Cancer Center Worthington Worthington, Minnesota
Sanford Joe Lueken Cancer Center Bemidji, Minnesota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford Medical Center Fargo Fargo, North Dakota
Sanford Roger Maris Cancer Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford South University Medical Center Fargo, North Dakota
Sanford Thief River Falls Medical Center Thief River Falls, Minnesota
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org)
Saskatoon Cancer Centre Saskatoon, Saskatchewan
Sechler Family Cancer Center Lebanon, Pennsylvania Site Public Contact - (doxenberg@wellspan.org)
Shaw Cancer Center Edwards, Colorado
Sibley Memorial Hospital Washington D.C., District of Columbia Site Public Contact - (jquiver1@jhmi.edu)
Sidney Kimmel Cancer Center Washington Township Sewell, New Jersey
Sidney and Lois Eskenazi Hospital Indianapolis, Indiana Site Public Contact - (iutrials@iu.edu)
Sinai Hospital of Baltimore Baltimore, Maryland Site Public Contact - (pridgely@lifebridgehealth.org)
Siouxland Regional Cancer Center Sioux City, Iowa Site Public Contact - (HoopingarnerT@jencc.com)
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)
Sky Ridge Medical Center Lone Tree, Colorado
Smilow Cancer Hospital Care Center - Waterford Waterford, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center at Glastonbury Glastonbury, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center at Saint Francis Hartford, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center-Fairfield Fairfield, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center-Trumbull Trumbull, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital-Torrington Care Center Torrington, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital-Waterbury Care Center Waterbury, Connecticut Site Public Contact - (canceranswers@yale.edu)
Solinsky Center for Cancer Care Manchester, New Hampshire
South Carolina Cancer Specialists PC Hilton Head Island, South Carolina Site Public Contact - (underberga@sjchs.org)
Southeast Cancer Center Cape Girardeau, Missouri
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)
Southpointe-Sanford Medical Center Fargo Fargo, North Dakota
Southwest Oncology PC Durango, Colorado
Spartanburg Medical Center Spartanburg, South Carolina Site Public Contact - (kmertz-rivera@gibbscc.org)
Springfield Clinic Springfield, Illinois
Springfield Regional Cancer Center Springfield, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Springfield Regional Medical Center Springfield, Ohio
Stamford Hospital/Bennett Cancer Center Stamford, Connecticut
Stanford Cancer Center South Bay San Jose, California Site Public Contact - (ccto-office@stanford.edu)
Stanford Cancer Institute Palo Alto Palo Alto, California Site Public Contact - (ccto-office@stanford.edu)
State University of New York Upstate Medical University Syracuse, New York
Stony Brook University Medical Center Stony Brook, New York
Straub Clinic and Hospital Honolulu, Hawaii
Strecker Cancer Center-Belpre Belpre, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Suburban Hematology Oncology Associates - Snellville Snellville, Georgia
Summerlin Hospital Medical Center Las Vegas, Nevada
Summit Cancer Care-Memorial Savannah, Georgia
Summit Health - Florham Park Campus Florham Park, New Jersey Site Public Contact - (mmackenzie@summithealth.com)
Summit Medical Group Berkeley Heights, New Jersey Site Public Contact - (ctsucontact@westat.com)
Sunrise Hospital and Medical Center Las Vegas, Nevada
Sutter Auburn Faith Hospital Auburn, California Site Public Contact - (NCIclinicaltrials@sutterhealth.org)
Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn, California
Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park, California
Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville, California
Sutter Cancer Centers Radiation Oncology Services-Vacaville Vacaville, California
Sutter Davis Hospital Davis, California
Sutter Medical Center Sacramento Sacramento, California Site Public Contact - (NCIclinicaltrials@sutterhealth.org)
Sutter Pacific Medical Foundation Santa Rosa, California Site Public Contact - (NCIclinicaltrials@sutterhealth.org)
Sutter Roseville Medical Center Roseville, California Site Public Contact - (NCIclinicaltrials@sutterhealth.org)
Sutter Solano Medical Center/Cancer Center Vallejo, California Site Public Contact - (NCIclinicaltrials@sutterhealth.org)
Swedish Cancer Institute-Edmonds Edmonds, Washington Site Public Contact - (PCRC-NCORP@Swedish.org)
Swedish Cancer Institute-Issaquah Issaquah, Washington Site Public Contact - (PCRC-NCORP@Swedish.org)
Swedish Covenant Hospital Chicago, Illinois
Swedish Medical Center 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)
Tampa General Hospital Tampa, Florida Site Public Contact - (syapchanyk@tgh.org)
Temple University Hospital Philadelphia, Pennsylvania
The Cancer Center of Hawaii-Liliha Honolulu, Hawaii
The Cancer Center of Hawaii-Pali Momi ‘Aiea, Hawaii
The Cancer Institute at Saint Francis Hospital East Hills, New York Site Public Contact - (Stephanie.Solito@chsli.org)
The Cancer Institute of New Jersey Hamilton Hamilton, New Jersey
The Carle Foundation Hospital Urbana, Illinois
The Christ Hospital Cincinnati, Ohio
The Don and Sybil Harrington Cancer Center Amarillo, Texas Site Public Contact - (Gina.Cravey@bsahs.org)
The Hospital of Central Connecticut New Britain, Connecticut
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 Women's Imaging Center Denver, Colorado
ThedaCare Cancer Care - Waupaca Waupaca, Wisconsin Site Public Contact - (ResearchDept@thedacare.org)
ThedaCare Regional Cancer Center Appleton, Wisconsin Site Public Contact - (ResearchDept@thedacare.org)
ThedaCare Regional Medical Center - Neenah Neenah, Wisconsin Site Public Contact - (ResearchDept@thedacare.org)
Thomas Hospital Fairhope, Alabama
Thomas Jefferson University Hospital Philadelphia, Pennsylvania Site Public Contact - (ONCTrialNow@jefferson.edu)
TidalHealth Nanticoke / Allen Cancer Center Seaford, Delaware
Tidelands Georgetown Memorial Hospital Georgetown, South Carolina Site Public Contact - (broe@tidelandshealth.org)
Toledo Clinic Cancer Centers-Monroe Monroe, Michigan
Toledo Clinic Cancer Centers-Toledo Toledo, Ohio
Torrance Memorial Physician Network - Cancer Care Torrance, California Site Public Contact - (courtney.steeneken@tmphysicians.com)
Tower Cancer Research Foundation Beverly Hills, California Site Public Contact - (towercancerresearch@toweroncology.com)
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)
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Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 2

Ryan Garten, PhD - rsgarten@vcu.edu

NA
NCT04922762
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Inclusion Criteria:
* apparently healthy and free of overt cardiovascular, pulmonary, or metabolic disease * for PTSD group, a score of ≥ 33 on PCL-5 checklist * for GAD group, a score of ≥ 10 on the GAD-7 self-report scale and \< 33 on the PCL-5 checklist * for Healthy Control group, a score of ≤ 10 on the GAD-7 self-report scale and \< 33 on the PCL-5 checklist
Exclusion Criteria:
* taking medications that could influence cardiovascular function * current smokers who have recently quit smoking * illicit drug use or excessive alcohol consumption * pregnant women * significant calorie restriction or vitamin/mineral deficiencies * limited English proficiency
BEHAVIORAL: Moderate Intensity, Normal Volume Exercise Training, BEHAVIORAL: High Intensity, Normal Volume Exercise Training, BEHAVIORAL: Moderate Intensity, High Volume Exercise Training
Peripheral Vascular Diseases
cardiovascular disease, vascular function, PTSD, GAD, Oxidant
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Virginia Commonwealth University Richmond, Virginia

A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes

Medical Information - medicalinfo@vrtx.com

Levy, Marlon
PHASE3
NCT04786262
HM20021228
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Key
Inclusion Criteria:
* Clinical history of T1D with \> 5 years of duration of insulin dependence * At least two episodes of documented severe hypoglycemia in the 12 months prior to enrollment * Stable diabetic treatment * Consistent use of continuous glucose monitor (CGM) for at least 3 months before Screening and willingness to use CGM for the duration of the study Key
Exclusion Criteria:
-Prior islet cell transplant, organ transplant, or cell therapy Other protocol defined Inclusion/Exclusion criteria may apply
BIOLOGICAL: VX-880
Diabetes Mellitus, Type 1, Impaired Hypoglycemic Awareness, Severe Hypoglycemia
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Study Locations

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Baylor Scott and White Research Institute Dallas, Texas
CHU Lille Lille,
Cardiovascular, Metabolic Medicine and Sciences, King's College London London,
Centre de recherche en Biomédecine de Strasbourg Strasbourg,
Churchill Hospital Oxford,
City of Hope Duarte, California
Dresden Center for Islet Transplantation Dresden,
Hopiteaux Universitaires de Geneve Geneve,
Hospital of the University of Pennsylvania Philadelphia, Pennsylvania
IRCCS Ospedale San Raffaele Milan,
Johns Hopkins University Baltimore, Maryland
King Abdullah International Medical Research Center (KAIMRC) - Riyadh - Endocrinology Riyadh,
King Faisal Specialist Hospital & Research Centre - Riyadh - Endocrinology Riyadh,
Leiden University Leiden,
Massachusetts General Hospital Boston, Massachusetts
McGill University Health Centre Montreal, Quebec
Northwestern Organ Transplant Center Chicago, Illinois
Oslo University Hospital Oslo,
Royal Infirmary of Edinburgh Edinburgh,
The Newcastle upon Tyne Hospitals NHS Foundation Trust Newcastle upon Tyne,
Toronto General Hospital (TGH) Toronto,
UHealth Diabetes Research Institute Miami, Florida
University of Alberta, Edmonton Edmonton,
University of California San Francisco San Francisco, California
University of Chicago Chicago, Illinois
University of Pittsburgh Medical Center Montefiore Pittsburgh, Pennsylvania
University of Wisconsin Madison, Wisconsin
VCU Medical Center, Richmond Richmond, Virginia
Vancouver General Hospital Vancouver, British Columbia

A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness (BLAZE-1)

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or - ClinicalTrials.gov@lilly.com

Koch, William, C
Phase 2/Phase 3
NCT04427501
HM20022495
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Inclusion Criteria:

• Are currently not hospitalized. (Not applicable to participants in treatment arm 22.)
• Have one or more mild or moderate COVID-19 symptoms: Fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion. (Not applicable to participants in treatment arm 22.)
• Must have sample taken for test confirming viral infection no more than 3 days prior to starting the drug infusion
• Are males or females, including pregnant females who agree to contraceptive requirements
• Understand and agree to comply with planned study procedures
• Agree to the collection of nasopharyngeal swabs and venous blood. (Not applicable to participants in treatment arms 20-21.)
• The participant or legally authorized representative give signed informed consent and/or assent Participants in treatment arms 7-9, 13-14, and 18-21 ONLY
• Are greater than or equal to (≥)18 years of age and must satisfy at least one of the following at the time of screening
• Are pregnant
• Are ≥65 years of age
• Have a body mass index (BMI) ≥35
• Have chronic kidney disease (CKD)
• Have type 1 or type 2 diabetes
• Have immunosuppressive disease
• Are currently receiving immunosuppressive treatment or
• Are ≥55 years of age AND have:
• cardiovascular disease (CVD), OR
• hypertension, OR
• chronic obstructive pulmonary disease (COPD) or other chronic respiratory disease
• Are 12-17 years of age (inclusive) AND satisfy at least one of the following at the time of screening
• Are pregnant
• Have a body mass index (BMI) ≥85th percentile for their age and gender based on CDC growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm
• Have sickle cell disease
• Have congenital or acquired heart disease
• Have neurodevelopmental disorders, for example, cerebral palsy
• Have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19)
• Have asthma or reactive airway or other chronic respiratory disease that requires daily medication for control
• Have type 1 or type 2 diabetes
• Have chronic kidney disease
• Have immunosuppressive disease, or
• Are currently receiving immunosuppressive treatment Participants in treatment arm 22 ONLY
• Are 0 (≥ 32 weeks gestational age AND ≥ 1.5 kilograms [kg]) to 17 years of age (inclusive) AND satisfy at least one of the following risk factors at the time of screening
• Are pregnant
• Have a BMI ≥85th percentile for their age and gender based on CDC growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm
• Have sickle cell disease
• Have congenital or acquired heart disease
• Have neurodevelopmental disorders, for example, cerebral palsy, autism, or Down syndrome (FAIR Health 2020; Spreat et al. 2020)
• Have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19)
• Have asthma, cystic fibrosis, reactive airways disease or other chronic respiratory disease that requires daily medication for control
• Have type 1 or type 2 diabetes
• Have chronic kidney disease
• Have immunosuppressive disease, or
• Are currently receiving immunosuppressive treatment, or
• Are less than (<) one year of age.
• Have one or more COVID-19 symptoms
• Shortness of breath/difficulty breathing
• Fever
• Sore throat
• Nausea
• Diarrhea
• Tiredness
• Headache
• New loss of taste
• Nasal congestion/runny nose
• Chills
• Stomachache
• Vomiting
• Cough
• Muscle/body aches and pain
• New loss of smell
• Poor appetite or poor feeding (in babies) Participants in treatment arm 23 ONLY: Must have first positive result sample of current SARS-CoV-2 viral infection ≤3 days prior to start of treatment administration. Participant can have COVID previously and still meet criteria for this addendum. Positive result needs to be from a current infection. Are 0 (≥ 38 weeks gestational age and ≥ 3.3 kg) to <12 years of age at the time of screening, or are 12 to 17 and weighing <40 kg; and
• Have mild to moderate COVID-19 disease, including one or more COVID-19 symptoms within the last 7 days
• Shortness of breath/difficulty breathing
• Fever
• Sore throat
• Nausea
• Diarrhea
• Tiredness
• Headache
• New loss of taste
• Nasal congestion/runny nose
• Chills
• Malaise
• Vomiting
• Cough
• Muscle/body aches and pain
• New loss of smell
• Poor appetite or poor feeding (in babies under 1 year old)
Exclusion Criteria:

• Have oxygen saturation (SpO2) less than or equal to (≤)93 percent (%) on room air at sea level or ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to fractional inspired oxygen (FiO2) less than (<)300, respiratory rate greater than or equal to (≥)30 per minute, heart rate ≥125 per minute due to COVID-19
• Require mechanical ventilation or anticipated impending need for mechanical ventilation due to COVID-19
• Have known allergies to any of the components used in the formulation of the interventions
• Have hemodynamic instability requiring use of pressors within 24 hours of randomization
• Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention
• Have any co-morbidity requiring surgery within <7 days, or that is considered life-threatening within 29 days
• Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study
• Have a history of a positive SARS-CoV-2 test prior to the one serving as eligibility for this study
• Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing
• Have received treatment with a SARS-CoV-2 specific monoclonal antibody
• Have received convalescent COVID-19 plasma treatment
• Have participated in a previous SARS-CoV-2 vaccine study or have received a SARS-CoV-2 vaccine
• Have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed
• Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
• Mothers who are breast feeding Participants in Treatment Arm 22 ONLY
• Have a diagnosis of Multisystem Inflammatory Syndrome in Children (MIS-C) in the opinion of the investigator
• Are currently hospitalized for treatment of COVID-19. Other reasons for hospitalization are acceptable. Participants in treatment arm 23 ONLY
• SpO2 ≤ 93% on room air at sea level, or while on chronic oxygen therapy and/or respiratory support due to underlying non-COVID-19 related comorbidity, respiratory rate ≥30 per minute, and heart rate ≥125 per minute due to COVID-19 (FDA February 2021)
• Require mechanical ventilation or anticipated impending need for mechanical ventilation due to COVID-19
• Have known allergies to any of the components used in the formulation of the interventions
• Have hemodynamic instability requiring use of pressors within 24 hours of randomization
• Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention
• Have any co-morbidity requiring surgery within 7 days, or that is considered life-threatening within 29 days
• Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study.
• Have received treatment with a SARS-CoV-2 specific monoclonal antibody or remdesivir within 90 days before dosing.
• Have received convalescent COVID-19 plasma treatment within 90 days before dosing
• Have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed
• Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
• Are currently pregnant or breast feeding
Drug: LY3819253, Drug: LY3832479, Drug: LY3853113, Drug: Placebo
COVID-19
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AMCR Institute Escondido, California
APD Clinical Research Splendora, Texas
Accurate Clinical Management, LLC. Houston, Texas
Advanced Clinical Research, LLC Bayamon,
Advent Health Tampa Tampa, Florida
Allianz Research Institute Westminster, California
Ann & Robert H Lurie Children's Hospital of Chicago Chicago, Illinois
Applied Rsch Ctr - Arkansas Inc. Little Rock, Arkansas
Arizona Clin Trials-Mesa Mesa, Arizona
Arizona Clin Trials-Tucson Tucson, Arizona
Ark Clinical Research Long Beach, California
Arkansas Children's Little Rock, Arkansas
Ascension St. John Tulsa OK Tulsa, Oklahoma
Aventiv Research Inc Columbus, Ohio
B S & W Med Center Irving, Texas
B S & W Med Center Irving, Texas
BRCR Medical Center, Inc McAllen, Texas
Bay Area Infectious Diseases Associates Pasadena, Texas
Baylor - Fort Worth Fort Worth, Texas
Baylor - Round Rock Round Rock, Texas
Baylor Scott and White Medical Center Temple, Texas
Be Well Clinical Studies Lincoln, Nebraska
Bio-Kinetic Clinical Applications, LLC Springfield, Missouri
Bio-Medical Research, LLC Miami, Florida
BioPharma Clinc Site Houston, Texas
BioPharma Family Practice Center McAllen McAllen, Texas
CARE ID Annandale, Virginia
CLS Research Ctr, PLLC Webster, Texas
CRI of Arizona, LLC Sun City West, Arizona
Care Access Research - Bronx Bronx, New York
Carolina Medical Research - Clinton Clinton, South Carolina
Carolina Medical Research - Greenville Greenville, South Carolina
Carolina Research Center, Inc. Shelby, North Carolina
Carteret Medical Group Morehead City, North Carolina
Catalina Research Institute, Llc Montclair, California
Cedars Sinai Medical Center Los Angeles, California
Centex-Houston Houston, Texas
Centex-Wesfield Houston, Texas
Central Georgia Infectious Disease Macon, Georgia
Central Valley Research, LLC Modesto, California
Chemidox Clinical Trials Lancaster, California
Children's Hospital of Philadelphia Philadelphia, Pennsylvania
Childrens Endocrine Clinic Omaha, Nebraska
Childrens Hospital of Michigan Detroit, Michigan
Cleveland Clinic Foundation Cleveland, Ohio
Clinical Site Partners, LLC DBA CSP Orlando Winter Park, Florida
Clinical Site Partners, LLC d/b/a CSP Miami Miami, Florida
Community Hospital South Indianapolis, Indiana
Conroe Willis Medical Research Conroe, Texas
Consano Clinical Research, LLC Shavano Park, Texas
Crossroads Clin Rch-Victoria Victoria, Texas
Crossroads Clinical Research Corpus Christi, Texas
Dorado Medical Complex Inc Dorado,
Driscoll Children's Hospital Corpus Christi, Texas
East Carolina University Greenville, North Carolina
Elixia CRC Hollywood, Florida
Encore Medical Research Hollywood, Florida
Encore Medical Research - Weston Weston, Florida
Epic Medical Research Red Oak, Texas
Evergreen Health Research Kirkland, Washington
Excel Clinical Research Las Vegas, Nevada
Fiel Family and Sports Medicine PC Tempe, Arizona
Franciscan Health Hammond Dyer, Indiana
Franciscan St. Francis Health Indianapolis, Indiana
Future Innovative Treatments LLC Colorado Springs, Colorado
GCM Medical Group, PSC - Hato Rey Site San Juan,
GCPR Saint Petersburg, Florida
Gadolin Research, LLC Beaumont, Texas
Georgetown Univ Sch of Med Washington, District of Columbia
Great Lakes Clinical Trials - Andersonville Chicago, Illinois
Great Lakes Research Group, Inc. Bay City, Michigan
Gwinnett Research Inst Buford, Georgia
Hasbro Children's Hospital Providence, Rhode Island
Henry Ford Hospital Detroit, Michigan
Holy Cross Hospital Inc. Fort Lauderdale, Florida
Holy Name Medical Center Teaneck, New Jersey
Hometown UC and Rch- Cincy Cincinnati, Ohio
Hope Clinical Research Canoga Park, California
Hope Clinical Trials, Inc. Miami, Florida
Houston Methodist Research Ins Houston, Texas
I R & Health Center, Inc. Hialeah, Florida
IACT Health - VHC Columbus, Georgia
Icahn Sch of Med at Mt. Sinai New York, New York
Imperial Health Urgent Care Center - Moss Bluff Moss Bluff, Louisiana
Infect Disease Doctors Med Grp Walnut Creek, California
Inland Empire Liver Foundation Rialto, California
Institute for Advanced Clinical Trials for Children Rockville, Maryland
J H. Stroger Hosp of Cook Co Chicago, Illinois
Jefferson Hosp for Neurosci Philadelphia, Pennsylvania
KLR Business Group, Inc. dba Arkansas Clinical Research Little Rock, Arkansas
Kaiser Permanente - SD Med Ctr San Diego, California
Lakeland Regional Medical Center Lakeland, Florida
Las Vegas Medical Research Las Vegas, Nevada
Long Beach Clinical Trials LLC Long Beach, California
META Medical Research Institute Dayton, Ohio
Massachusetts General Hospital Boston, Massachusetts
Mazur, Statner, Dutta, Nathan Thousand Oaks, California
Miami Cancer Institute at Baptist Health, Inc. Miami, Florida
Monroe Biomed Research Monroe, North Carolina
Nemours Childrens Clinic - Delaware Valley of The Nemours Foundation Wilmington, Delaware
New Phase Research and Development Knoxville, Tennessee
Next Level Urgent Care Houston, Texas
Nola Research Works, LLC New Orleans, Louisiana
North Hills Medical Research North Richland Hills, Texas
North Texas Clinical Trials, LLC Fort Worth, Texas
Northwestern University Chicago, Illinois
OH State Univ College of Med Columbus, Ohio
Olive Branch Family Medical Center Olive Branch, Mississippi
OnSite Clinical Solutions Charlotte, North Carolina
Orange Grove Banner Clinic Tucson, Arizona
PMG Research of Wilmington Wilmington, North Carolina
Panax Clinical Research Miami Lakes, Florida
Paramount Rch Sol - College Pk College Park, Georgia
Perseverance Research Center Scottsdale, Arizona
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Testing the Use of Combination Therapy in Adult Patients With Newly Diagnosed Multiple Myeloma, the EQUATE Trial (EQUATE)

Lantis, Kristin - kllantis@vcu.edu

Yazbeck, Victor, Y
PHASE3
NCT04566328
HM20022350
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Inclusion Criteria:
* STEP 0 - Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2 (PS 3 allowed if secondary to pain) * STEP 0 - Patient must have newly diagnosed multiple myeloma (MM) by International Myeloma Working Group (IMWG) criteria * STEP 0 - Patient must agree to register to the mandatory REVLIMID Risk Evaluation and Mitigation Strategy (RevREMS) program and be willing and able to comply with the requirements of RevREMS * STEP 0 - Patient must be able to undergo diagnostic bone marrow aspirate following preregistration. * NOTE: Bone marrow aspirate specimen must be submitted to Adaptive Biotechnologies for clonoSEQ Assay * NOTE: Adaptive Biotechnologies will release results to the diagnostic Portal from the Clonality (ID) test within fourteen (14) days of receipt and reconciliation of fresh bone marrow specimen to the submitting institution * STEP 1 - Patient must meet all eligibility criteria in STEP 0 with exception of allergy requirement * STEP 1 - Institution must have received the Clonality (ID) test results from Adaptive Biotechnologies and dominant sequences were identified * STEP 1 - Patient must have standard risk MM as defined by the Revised International Staging System (RISS) stage I or II * NOTE: R-ISS stage is based on serum beta2 microglobulin, albumin and lactate dehydrogenase (LDH) levels along with presence of chromosomal abnormalities (CA) detected by interphase fluorescent in situ hybridization (iFISH). Presence of del(17p), t(4;14), and/or t(14;16) is considered high risk and absence of these, including any other findings, are standard risk * R-ISS stage * Stage I: ISS stage I \[beta2 macroglobulin \< 3.5 mg/L, albumin \> 3.5 g/dL\] AND standard-risk CA AND normal LDH * Stage II: Not R-ISS stage I or III * Stage III: ISS stage III \[beta2 macroglobulin \> 5.5 mg/L\] AND high-risk CA OR high LDH (\> upper limit of normal) \[patients with stage III are ineligible\] * STEP 1 - Patient must have measurable or evaluable disease as defined by having one or more of the following, obtained within 28 days prior to registration: * \>= 1 g/dL monoclonal protein (M-protein) on serum protein electrophoresis * \>= 200 mg/24 hours of monoclonal protein on a 24-hour urine protein electrophoresis * Involved free light chain \>= 10 mg/dL or \>= 100 mg/L AND abnormal serum immunoglobulin kappa to lambda free light chain ratio (\< 0.26 or \> 1.65) * Monoclonal bone marrow plasmacytosis \>= 30% (evaluable disease) * STEP 1 - Patients must have a serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP), and serum free light chain (FLC) assay performed within 28 days prior to registration. In addition, a bone marrow biopsy and/or aspirate is required within 28 days if bone marrow is being followed for response * NOTE: UPEP (on a 24-hour collection) is required, no substitute method is acceptable. Urine must be followed monthly if the baseline urine M-spike is \>= 200 mg/24 hr. Please note that if both serum and urine M-components are present, both must be followed in order to evaluate response * NOTE: The serum free light chain test is required to be done if the patient does not have measurable disease in the serum or urine. Measurable disease in the serum is defined as having a serum M-spike \>= 1 g/dL. Measurable disease in the urine is defined as having a urine M-spike \>= 200 mg/24 hr * STEP 1 - Calculated creatinine clearance \> 30 mL/min (obtained =\< 14 days prior to Step 1 registration) * STEP 1 - Absolute neutrophil count (ANC) \>= 1000/mm\^3 (obtained =\< 14 days prior to Step 1 registration) * STEP 1 - Untransfused platelet count \>= 75,000/mm\^3 (obtained =\< 14 days prior to Step 1 registration) * STEP 1 - Hemoglobin \>= 8.0 g/dL (obtained =\< 14 days prior to Step 1 registration) * STEP 1 - Total bilirubin =\< 1.5 x ULN (institutional upper limit of normal) (obtained =\< 14 days prior to Step 1 registration) * STEP 1 - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x ULN (obtained =\< 14 days prior to Step 1 registration) * STEP 1 - Patient must have received no more than one cycle (28 days or less) of prior chemotherapy and no more than 160 mg of prior dexamethasone (or equivalent dose of prednisone) for treatment of symptomatic myeloma. Patient must not have been exposed to daratumumab for treatment of symptomatic myeloma. Prior radiation therapy to symptomatic lesions is allowed provided there are no residual toxicity related to radiation and blood counts meet the study requirements. Radiation treatment must be completed at least 14 days prior to Step 1 registration * STEP 1 - Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial * STEP 1 - For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * STEP 1 - 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 * STEP 1 - 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 * STEP 1 - 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 evidence of current uncontrolled cardiovascular conditions, including hypertension, cardiac arrhythmias, congestive heart failure, unstable angina, or myocardial infarction within 6 months prior to Step 1 registration * STEP 1 - Patient may have a history of current or previous deep vein thrombosis (DVT) or pulmonary embolism (PE) but must be willing to take some form of anti-coagulation as prophylaxis if they are not currently on full-dose anticoagulation * STEP 1 - Patients with a history of chronic obstructive pulmonary disease (COPD) must have FEV1 testing done within 28 days prior to Step 1 registration and the forced expiratory volume in 1 second (FEV1) must be \> 50% of predicted normal * STEP 2 - Institution must have received Tracking (MRD) test results from Adaptive Biotechnologies * STEP 2 - Patient must have completed the Step 1 Induction phase of this protocol without experiencing progression * STEP 2 - Patient must be registered to Step 2 within 8 weeks of completing Step 1 Induction Treatment, counting from last day of completion of last cycle * STEP 2 - Patient must have an ECOG performance status (PS) of 0-2 (PS 3 allowed if secondary to pain) * STEP 2 - Any adverse event(s) related to Step 1 Induction Treatment must have resolved to grade 2 or less * STEP 2 - Hemoglobin \>= 8 g/dL (obtained within 14 days prior to Step 2 randomization) * STEP 2 - Platelet count \>= 50,000/mm\^3 (obtained within 14 days prior to Step 2 randomization) * STEP 2 - Absolute neutrophil count (ANC) \>= 1000/mm\^3 (obtained within 14 days prior to Step 2 randomization) * STEP 2 - Calculated creatinine clearance \>= 30 mL/min (obtained within 14 days prior to Step 2 randomization) * STEP 2 - Total bilirubin =\< 1.5 x ULN (Institutional upper limit of normal) (obtained within 14 days prior to Step 2 randomization) * STEP 2 - ALT and AST \< 3 x ULN (obtained within 14 days prior to Step 2 randomization)
Exclusion Criteria:
* STEP 0 - Patient must not have any known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients (refer to respective package inserts or Investigator's Brochure), or known sensitivity to mammalian-derived products * STEP 1 - Women must not be pregnant or breast-feeding due to the potential harm and teratogenic effects to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All females of childbearing potential must have a blood test or urine study with a sensitivity of at least 25 mIU/mL within 10-14 days prior to Step 1 registration to rule out pregnancy and again within 24 hours prior to the first dose of lenalidomide. Females of childbearing potential must also agree to ongoing pregnancy testing while on protocol treatment. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: * Has achieved menarche at some point, * Has not undergone a hysterectomy or bilateral oophorectomy; or * 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) * STEP 1 - Women of childbearing potential must not expect to conceive children by using accepted and effective method(s) of contraception (for this protocol defined as the use of TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME for 1) at least 28 days before starting protocol treatment; 2) while participating in the study; 3) during dose interruptions; and 4) for at least 3 months days after the last dose of protocol treatment) OR by practicing true abstinence from sexual intercourse for the duration of their participation in the study (periodic abstinence \[e.g., calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable methods of contraception). Men must not expect to father children by practicing true abstinence from sexual intercourse for the duration of their participation in the study (periodic abstinence \[e.g., calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable methods of contraception) OR use a latex condom during sexual contact with a female of child bearing potential while participating in the study and for at least 3 months after the last dose of protocol treatment even if they have had a successful vasectomy. Men must also agree to abstain from donating sperm while on study treatment and for 3 months after the last dose of protocol treatment even if they have had a successful vasectomy. Both women and men must both agree to abstain from donating blood during study participation and for at least 28 days after the last dose of protocol treatment * STEP 1 - Patient must not have peripheral neuropathy \>= grade 2 on clinical examination or grade 1 with pain at time of Step 1 registration * STEP 1 - Patient must not have any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol * STEP 1 - Patient must not have moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification * NOTE: Patients who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to register * STEP 1 - Patient must not receive any other concurrent chemotherapy, or any ancillary therapy considered investigational while on this protocol * NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment * STEP 2 - Patient must not have received any non-protocol therapy outside of the assigned Step 1 Induction treatment including stem cell transplant * STEP 2 - Women must not be pregnant or breast-feeding due to the potential harm and teratogenic effects to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All females of childbearing potential must have a blood test or urine study with a sensitivity of at least 25 mIU/mL within 10-14 days prior to Step 2 randomization to rule out pregnancy and again within 24 hours prior to the first dose of lenalidomide. Females of childbearing potential must also agree to ongoing pregnancy testing while on protocol treatment. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: * Has achieved menarche at some point, * Has not undergone a hysterectomy or bilateral oophorectomy; or * 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). * STEP 2 - Women of childbearing potential must not expect to conceive children by using accepted and effective method(s) of contraception (for this protocol defined as the use of TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME for 1) at least 28 days before starting protocol treatment; 2) while participating in the study; 3) during dose interruptions; and 4) for at least 3 months days after the last dose of protocol treatment) OR by practicing true abstinence from sexual intercourse for the duration of their participation in the study (periodic abstinence \[e.g., calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable methods of contraception). Men must not expect to father children by practicing true abstinence from sexual intercourse for the duration of their participation in the study (periodic abstinence \[e.g., calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable methods of contraception) OR use a latex condom during sexual contact with a female of child bearing potential while participating in the study and for at least 3 months after the last dose of protocol treatment even if they have had a successful vasectomy. Men must also agree to abstain from donating sperm while on study treatment and for 3 months after the last dose of protocol treatment even if they have had a successful vasectomy. Both women and men must both agree to abstain from donating blood during study participation and for at least 28 days after the last dose of protocol treatment
DRUG: Bortezomib, BIOLOGICAL: Daratumumab and Hyaluronidase-fihj, DRUG: Dexamethasone, DRUG: Lenalidomide, OTHER: Quality-of-Life Assessment
Plasma Cell Myeloma, RISS Stage I Plasma Cell Myeloma, RISS Stage II Plasma Cell Myeloma
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AMG Crystal Lake - Oncology Crystal Lake, Illinois Site Public Contact - (advocateresearch@advocate.com)
AMG Libertyville - Oncology Libertyville, Illinois Site Public Contact - (advocateresearch@advocatehealth.com)
Abbott-Northwestern Hospital Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Academic Hematology Oncology Specialists Grosse Pointe Woods, Michigan
Adena Regional Medical Center Chillicothe, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Advanced Breast Care Center PLLC Warren, Michigan
Advocate Christ Medical Center Oak Lawn, Illinois
Advocate Good Samaritan Hospital Downers Grove, Illinois Site Public Contact - (Barbara.barhamand@advocatehealth.com)
Advocate Good Shepherd Hospital Barrington, Illinois
Advocate Illinois Masonic Medical Center Chicago, Illinois
Advocate Lutheran General Hospital Park Ridge, Illinois
Advocate Sherman Hospital Elgin, Illinois
Advocate South Suburban Hospital Hazel Crest, Illinois
Alaska Breast Care and Surgery LLC Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Alaska Oncology and Hematology LLC Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Alaska Women's Cancer Care Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
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Alta Bates Summit Medical Center-Herrick Campus Berkeley, California Site Public Contact - (NCIclinicaltrials@sutterhealth.org)
Anchorage Associates in Radiation Medicine Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
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Anchorage Radiation Therapy Center Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Armes Family Cancer Center Findlay, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
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Central Ohio Breast and Endocrine Surgery Gahanna, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Centralia Oncology Clinic Centralia, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Centro Comprensivo de Cancer de UPR San Juan, Site Public Contact - (ecog.rss@jimmy.harvard.edu)
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Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
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Cox Cancer Center Branson Branson, Missouri
CoxHealth South Hospital Springfield, Missouri
Creighton University Medical Center Omaha, Nebraska Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Crossroads Cancer Center Effingham, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
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Decatur Memorial Hospital Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Delaware Clinical and Laboratory Physicians PA Newark, Delaware
Delaware Health Center-Grady Cancer Center Delaware, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Delbert Day Cancer Institute at PCRMC Rolla, Missouri Site Public Contact - (research@phelpshealth.org)
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Dublin Methodist Hospital Dublin, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
ECU Health Oncology Kenansville Kenansville, North Carolina Site Public Contact - (research@ecuhealth.org)
ECU Health Oncology Kinston Kinston, North Carolina Site Public Contact - (research@ecuhealth.org)
ECU Health Oncology Richlands Richlands, North Carolina Site Public Contact - (research@ecuhealth.org)
East Carolina University Greenville, North Carolina Site Public Contact - (eubankss@ecu.edu)
Eden Hospital Medical Center Castro Valley, California Site Public Contact - (NCIclinicaltrials@sutterhealth.org)
FMH James M Stockman Cancer Institute Frederick, Maryland
Fairfield Medical Center Lancaster, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Fairview Clinics and Surgery Center Maple Grove Maple Grove, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Fairview Lakes Medical Center Wyoming, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Fairview Northland Medical Center Princeton, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Fairview Ridges Hospital Burnsville, Minnesota
Fairview Southdale Hospital Edina, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Flaget Memorial Hospital Bardstown, Kentucky Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Franciscan Research Center-Northwest Medical Plaza Tacoma, Washington
Frederick Memorial Hospital Frederick, Maryland
Freeman Health System Joplin, Missouri Site Public Contact - (LJCrockett@freemanhealth.com)
Geauga Hospital Chardon, Ohio
Geisinger Cancer Services-Pottsville Pottsville, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Medical Center Danville, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Medical Center-Cancer Center Hazleton Hazleton, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Medical Oncology-Lewisburg Lewisburg, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Genesee Cancer and Blood Disease Treatment Center Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Genesee Hematology Oncology PC Flint, Michigan Site Public Contact - (wstrong@ghci.org)
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 - Cincinnati Cincinnati, Ohio Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Good Samaritan Regional Health Center Mount Vernon, Illinois
Good Samaritan University Hospital West Islip, New York
Grady Memorial Hospital Atlanta, Georgia Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Grant Medical Center Columbus, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Great Falls Clinic Great Falls, Montana Site Public Contact - (mccinfo@mtcancer.org)
Great Lakes Cancer Management Specialists-Doctors Park East China Township, Michigan
Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb, Michigan
Great Lakes Cancer Management Specialists-Macomb Professional Building Warren, Michigan
Great Lakes Cancer Management Specialists-Rochester Hills Rochester Hills, Michigan
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods, Michigan
Greater Dayton Cancer Center Kettering, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Greater Regional Medical Center Creston, Iowa Site Public Contact - (cancerresearch@mercydesmoines.org)
Gundersen Lutheran Medical Center La Crosse, Wisconsin Site Public Contact - (cancerctr@gundersenhealth.org)
HSHS Sacred Heart Hospital Eau Claire, Wisconsin Site Public Contact - (ewd_research_admin@hshs.org)
HSHS Saint Elizabeth's Hospital O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Harrison HealthPartners Hematology and Oncology-Bremerton Bremerton, Washington Site Public Contact - (clinicaltrials@sfmc-gi.org)
Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo, Washington
Hartford Hospital Hartford, Connecticut
Health Partners Inc Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Heartland Regional Medical Center Saint Joseph, Missouri Site Public Contact - (linda.schumacher@mymlc.com)
Helen F Graham Cancer Center Newark, Delaware
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 Associates of Central New York-Onondaga Hill Syracuse, New York
Hematology Oncology Consultants-Clarkston Clarkston, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Hennepin County Medical Center Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Hickman Cancer Center Adrian, Michigan
Highline Medical Center-Main Campus Burien, Washington
Holy Cross Hospital Fort Lauderdale, Florida Site Public Contact - (eileen.georgi@holy-cross.com)
Hope Cancer Center Pontiac, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
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)
IU Health Methodist Hospital Indianapolis, Indiana Chelsea Young - (youngchs@iu.edu)
IU Health North Hospital Carmel, Indiana Chelsea Young - (youngchs@iu.edu)
Idaho Urologic Institute-Meridian Meridian, Idaho Site Public Contact - (stephanie.couch@stjoeshealth.org)
Illinois CancerCare - Washington Washington, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Bloomington Bloomington, Illinois 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 Chelsea Young - (youngchs@iu.edu)
Indu and Raj Soin Medical Center Beavercreek, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Inova Fairfax Hospital Falls Church, Virginia Site Public Contact - (Stephanie.VanBebber@inova.org)
Inova Schar Cancer Institute Fairfax, Virginia Site Public Contact - (Stephanie.VanBebber@inova.org)
Iowa Lutheran Hospital Des Moines, Iowa
Iowa Methodist Medical Center Des Moines, Iowa
Jewish Hospital Louisville, Kentucky
Jewish Hospital Medical Center South Shepherdsville, Kentucky
John H Stroger Jr Hospital of Cook County Chicago, Illinois
John L McClellan Memorial Veterans Hospital Little Rock, Arkansas
Kadlec Clinic Hematology and Oncology Kennewick, Washington Site Public Contact - (research@kadlecmed.org)
Kalispell Regional Medical Center Kalispell, Montana Site Public Contact - (mccinfo@mtcancer.org)
Katmai Oncology Group Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Kettering Medical Center Kettering, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Knox Community Hospital Mount Vernon, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho Site Public Contact - (mccinfo@mtcancer.org)
LSU Health Baton Rouge-North Clinic Baton Rouge, Louisiana Site Public Contact - (research@ololrmc.com)
LSU Health Sciences Center at Shreveport Shreveport, Louisiana Site Public Contact - (LPost@lsuhsc.edu)
Lake Regional Hospital Osage Beach, Missouri Site Public Contact - (clinicaltrials@lakeregional.com)
Lakeview Hospital Stillwater, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Lehigh Valley Hospital-Hazleton Hazleton, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Licking Memorial Hospital Newark, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Littleton Adventist Hospital Littleton, Colorado
Longmont United Hospital Longmont, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Louis Stokes Cleveland VA Medical Center Cleveland, Ohio Site Public Contact - (holly.henry@va.gov)
Lourdes Hospital Binghamton, New York
Loyola Center for Health at Burr Ridge Burr Ridge, Illinois
Loyola Medicine Homer Glen Homer Glen, Illinois
Loyola University Medical Center Maywood, Illinois
MU Health Care Goldschmidt Cancer Center Jefferson City, Missouri
Macomb Hematology Oncology PC Warren, Michigan
Marietta Memorial Hospital Marietta, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Marjorie Weinberg Cancer Center at Loyola-Gottlieb Melrose Park, Illinois
Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Clinic-Chippewa Center Chippewa Falls, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Clinic-Minocqua Center Minocqua, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Clinic-Wausau Center Wausau, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center - Ladysmith Ladysmith, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center - Neillsville Neillsville, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center - Weston Weston, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-Marshfield Marshfield, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-Rice Lake Rice Lake, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Mary Greeley Medical Center Ames, Iowa
Mayo Clinic Health System-Franciscan Healthcare La Crosse, Wisconsin
Mayo Clinic in Rochester Rochester, Minnesota
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
Medical Oncology Hematology Consultants PA Newark, Delaware
Medical University of South Carolina Charleston, South Carolina Site Public Contact - (hcc-clinical-trials@musc.edu)
Memorial Hospital Marysville, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Memorial Hospital of Carbondale Carbondale, Illinois Site Public Contact - (clinical.research@sih.net)
Memorial Medical Center Modesto, California Site Public Contact - (NCIclinicaltrials@sutterhealth.org)
Memorial Medical Center Modesto, California Site Public Contact - (pallante.beth@mhsil.com)
Mercy Cancer Center Merced, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mercy Cancer Center - Carmichael Carmichael, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mercy Cancer Center - Elk Grove Elk Grove, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mercy Cancer Center - Rocklin Rocklin, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mercy Cancer Center - Sacramento Sacramento, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mercy Cancer Center-West Lakes Clive, Iowa Site Public Contact - (cancerresearch@mercydesmoines.org)
Mercy Clinic-Rolla-Cancer and Hematology Rolla, Missouri
Mercy Health - Saint Anne Hospital Toledo, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Mercy Health - Saint Vincent Hospital Toledo, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Mercy Health Perrysburg Cancer Center Perrysburg, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Mercy Health Sylvania Radiation Oncology Center Toledo, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Mercy Hospital Coon Rapids, Minnesota
Mercy Hospital Coon Rapids, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Mercy Hospital Fort Smith Fort Smith, Arkansas
Mercy Hospital Joplin Joplin, Missouri Site Public Contact - (esmeralda.carrillo@mercy.net)
Mercy Hospital Oklahoma City Oklahoma City, Oklahoma
Mercy Hospital Saint Louis St Louis, Missouri
Mercy Hospital South St Louis, Missouri Site Public Contact - (Danielle.Werle@mercy.net)
Mercy Hospital Springfield Springfield, Missouri
Mercy Hospital Washington Washington, Missouri
Mercy Medical Center Durango, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mercy Medical Center - Des Moines Des Moines, Iowa Site Public Contact - (cancerresearch@mercydesmoines.org)
Mercy Medical Center-West Lakes West Des Moines, Iowa Site Public Contact - (cancerresearch@mercydesmoines.org)
Mercy San Juan Medical Center Carmichael, California Site Public Contact - (OncologyResearch@DignityHealth.org)
Methodist Medical Center of Illinois Peoria, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Methodist West Hospital West Des Moines, Iowa
MetroHealth Medical Center Cleveland, Ohio Site Public Contact - (ababal@metrohealth.org)
Miami Valley Cancer Care and Infusion Greenville, Ohio
Miami Valley Hospital Dayton, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Miami Valley Hospital North Dayton, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Miami Valley Hospital South Centerville, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Michigan Breast Specialists-Grosse Pointe Woods Grosse Pointe Woods, Michigan
Michigan Breast Specialists-Macomb Township Macomb, Michigan
Michigan Breast Specialists-Warren Warren, Michigan
Michigan Healthcare Professionals Pontiac Pontiac, Michigan Site Public Contact - (Emily.Crofts@trinity-health.org)
Midlands Community Hospital Papillion, Nebraska
Midstate Medical Center Meriden, Connecticut
Mills Health Center San Mateo, California Site Public Contact - (NCIclinicaltrials@sutterhealth.org)
Minnesota Oncology - Burnsville Burnsville, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Mission Cancer and Blood - Ankeny Ankeny, Iowa
Mission Cancer and Blood - Des Moines Des Moines, Iowa
Mission Cancer and Blood - Laurel Des Moines, Iowa
Mission Cancer and Blood - West Des Moines Clive, Iowa
Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mission Hope Medical Oncology - Santa Maria Santa Maria, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Missouri Baptist Medical Center St Louis, Missouri
Missouri Baptist Sullivan Hospital Sullivan, Missouri
Monticello Cancer Center Monticello, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Morristown Medical Center Morristown, New Jersey
Mount Carmel East Hospital Columbus, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Mount Carmel Grove City Hospital Grove City, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Mount Carmel Health Center West Columbus, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Mount Carmel New Albany Surgical Hospital New Albany, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Munson Medical Center Traverse City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Nebraska Cancer Specialists/Oncology Hematology West PC Grand Island, Nebraska
New Ulm Medical Center New Ulm, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Newark Radiation Oncology Newark, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Newland Medical Associates-Clarkston Clarkston, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Newland Medical Associates-Pontiac Pontiac, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
North Memorial Medical Health Center Robbinsdale, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
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)
Ochsner LSU Health Monroe Medical Center Monroe, Louisiana Site Public Contact - (LPost@lsuhsc.edu)
OhioHealth Mansfield Hospital Mansfield, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
OhioHealth Marion General Hospital Marion, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa
Oncology Hematology Associates of Saginaw Valley PC Saginaw, Michigan Site Public Contact - (lori.srebinski@ascension.org)
Oncology Hematology Care Inc-Kenwood Cincinnati, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Oregon Health and Science University Portland, Oregon Site Public Contact - (trials@ohsu.edu)
Orion Cancer Care Findlay, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Our Lady of the Lake Physician Group Baton Rouge, Louisiana Site Public Contact - (research@ololrmc.com)
Overlook Hospital Summit, New Jersey
PROncology San Juan, Site Public Contact - (info@PRoncology.com)
Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Pacific Gynecology Specialists Seattle, Washington
Palo Alto Medical Foundation Health Care Palo Alto, California Site Public Contact - (NCIclinicaltrials@sutterhealth.org)
Palo Alto Medical Foundation-Camino Division Mountain View, California Site Public Contact - (NCIclinicaltrials@sutterhealth.org)
Palo Alto Medical Foundation-Fremont Fremont, California Site Public Contact - (NCIclinicaltrials@sutterhealth.org)
Palo Alto Medical Foundation-Gynecologic Oncology Mountain View, California Site Public Contact - (NCIclinicaltrials@sutterhealth.org)
Palo Alto Medical Foundation-Santa Cruz Santa Cruz, California Site Public Contact - (NCIclinicaltrials@sutterhealth.org)
Palo Alto Medical Foundation-Sunnyvale Sunnyvale, California Site Public Contact - (NCIclinicaltrials@sutterhealth.org)
Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Parker Adventist Hospital Parker, Colorado
Parkland Health Center - Farmington Farmington, Missouri
PeaceHealth Saint John Medical Center Longview, Washington Site Public Contact - (kmakin-bond@peacehealth.org)
PeaceHealth Saint Joseph Medical Center Bellingham, Washington
PeaceHealth Southwest Medical Center Vancouver, Washington Site Public Contact - (kmakin-bond@peacehealth.org)
PeaceHealth United General Medical Center Sedro-Woolley, Washington Site Public Contact - (lkey@peacehealth.org)
Penn State Health Medical Group - Andrews Patel Hematology/Oncology East Harrisburg, Pennsylvania
Penn State Health Saint Joseph Medical Center Reading, Pennsylvania Site Public Contact - (dward1@pennstatehealth.psu.edu)
Penn State Milton S Hershey Medical Center Hershey, Pennsylvania Site Public Contact - (CTO@hmc.psu.edu)
Penrose-Saint Francis Healthcare Colorado Springs, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Pocono Medical Center East Stroudsburg, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Porter Adventist Hospital Denver, Colorado
Premier Blood and Cancer Center Dayton, Ohio
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 Alaska Medical Center Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Providence Cancer Institute Clackamas Clinic Clackamas, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Newberg Medical Center Newberg, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Portland Medical Center Portland, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Regional Cancer Partnership Everett, Washington Site Public Contact - (marilyn.birchman@providence.org)
Providence Regional Cancer System-Aberdeen Aberdeen, Washington Site Public Contact - (deidre.dillon@providence.org)
Providence Regional Cancer System-Centralia Centralia, Washington Site Public Contact - (deidre.dillon@providence.org)
Providence Regional Cancer System-Lacey Lacey, Washington Site Public Contact - (deidre.dillon@providence.org)
Providence Regional Cancer System-Shelton Shelton, Washington Site Public Contact - (deidre.dillon@providence.org)
Providence Regional Cancer System-Yelm Yelm, Washington Site Public Contact - (deidre.dillon@providence.org)
Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank, California
Providence Saint Mary Regional Cancer Center Walla Walla, Washington Site Public Contact - (Cheryl.Dodd@providence.org)
Providence Saint Vincent Medical Center Portland, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Willamette Falls Medical Center Oregon City, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Puerto Rico Hematology Oncology Group Bayamón,
Ralph H Johnson VA Medical Center Charleston, South Carolina Site Public Contact - (ashley.salvo@va.gov)
Reading Hospital West Reading, Pennsylvania
Regions Hospital Saint Paul, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Reid Health Richmond, Indiana Site Public Contact - (clinical.trials@daytonncorp.org)
Rice Memorial Hospital Willmar, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Ridgeview Medical Center Waconia, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Riverside Methodist Hospital Columbus, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Rocky Mountain Cancer Centers-Longmont Longmont, Colorado
Rocky Mountain Cancer Centers-Penrose Colorado Springs, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Rush - Copley Medical Center Aurora, Illinois Site Public Contact - (Cancer.Research@rushcopley.com)
Rush-Copley Healthcare Center Yorkville, Illinois Site Public Contact - (Cancer.Research@rushcopley.com)
SIH Cancer Institute Carterville, Illinois Site Public Contact - (clinical.research@sih.net)
SSM Health Dean Medical Group - Baraboo Baraboo, Wisconsin
SSM Health Dean Medical Group - Janesville Janesville, Wisconsin
SSM Health Dean Medical Group - South Madison Campus Madison, Wisconsin
Sacred Heart Hospital Pensacola, Florida Site Public Contact - (eebrou@ascension.org)
Saint Alphonsus Cancer Care Center-Baker City Baker City, Oregon Site Public Contact - (mccinfo@mtcancer.org)
Saint Alphonsus Cancer Care Center-Boise Boise, Idaho Site Public Contact - (stephanie.couch@stjoeshealth.org)
Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho Site Public Contact - (stephanie.couch@stjoeshealth.org)
Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon Site Public Contact - (mccinfo@mtcancer.org)
Saint Ann's Hospital Westerville, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Saint Anthony Hospital Lakewood, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Saint Anthony Regional Hospital Carroll, Iowa Site Public Contact - (sbenson@iora.org)
Saint Anthony's Health Alton, Illinois
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 Site Public Contact - (clinical.trials@daytonncorp.org)
Saint Elizabeth Hospital Enumclaw, Washington
Saint Elizabeth Regional Medical Center Lincoln, Nebraska
Saint Elizabeth Youngstown Hospital Youngstown, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Saint Francis Cancer Center Greenville, South Carolina Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Saint Francis Cancer Center Greenville, South Carolina
Saint Francis Hospital Greenville, South Carolina
Saint Francis Hospital Greenville, South Carolina
Saint Francis Medical Center Cape Girardeau, Missouri Site Public Contact - (sfmc@sfmc.net)
Saint Francis Regional Medical Center Shakopee, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Saint John Macomb-Oakland Hospital Warren, Michigan Site Public Contact - (karen.forman@ascension.org)
Saint John's Hospital - Healtheast Maplewood, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Saint Joseph Hospital Lexington, Kentucky Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Saint Joseph Hospital East Lexington, Kentucky Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Saint Joseph London London, Kentucky Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Saint Joseph Mount Sterling Mount Sterling, Kentucky Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Saint Joseph Radiation Oncology Resource Center Lexington, Kentucky Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Saint Joseph Regional Cancer Center Bryan, Texas
Saint Joseph Warren Hospital Warren, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Saint Louis Cancer and Breast Institute-Ballwin Ballwin, Missouri
Saint Louis Cancer and Breast Institute-South City St Louis, Missouri
Saint Luke's Cancer Institute - Boise Boise, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Meridian Meridian, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Nampa Nampa, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Twin Falls Twin Falls, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Hospital Chesterfield, Missouri
Saint Mary Corwin Medical Center Pueblo, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Saint Mary's Hospital Centralia, Illinois Site Public Contact - (ecog.rss@jimmy.harvard.edu)
Saint Mary's Oncology/Hematology Associates of Marlette Marlette, Michigan Site Public Contact - (lori.srebinski@ascension.org)
Saint Mary's Oncology/Hematology Associates of West Branch West Branch, Michigan Site Public Contact - (lori.srebinski@ascension.org)
Saint Michael Cancer Center Silverdale, Washington Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Saint Patrick Hospital - Community Hospital Missoula, Montana Site Public Contact - (amy.hanneman@providence.org)
Saint Rita's Medical Center Lima, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin Site Public Contact - (ewd_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin Site Public Contact - (ewd_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin Site Public Contact - (ewd_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin Site Public Contact - (ewd_research_admin@hshs.org)
Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri
Saints Mary and Elizabeth Hospital Louisville, Kentucky
San Juan City Hospital San Juan,
San Juan Community Oncology Group San Juan,
Sanford Bismarck Medical Center Bismarck, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford Broadway Medical Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford Joe Lueken Cancer Center Bemidji, Minnesota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford Medical Center Fargo Fargo, North Dakota
Sanford Roger Maris Cancer Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford South University Medical Center Fargo, North Dakota
Sanford Thief River Falls Medical Center Thief River Falls, Minnesota
Siouxland Regional Cancer Center Sioux City, Iowa Site Public Contact - (HoopingarnerT@jencc.com)
Skagit Regional Health Cancer Care Center Mount Vernon, Washington Site Public Contact - (rcccclinicalresearch@skagitvalleyhospital.org)
Smilow Cancer Center/Yale-New Haven Hospital New Haven, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center - Guilford Guilford, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center - Waterford Waterford, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center - Westerly Westerly, Rhode Island Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center at Glastonbury Glastonbury, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center at Greenwich Greenwich, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center at Saint Francis Hartford, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center-Fairfield Fairfield, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center-Trumbull Trumbull, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital-Derby Care Center Derby, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital-Orange Care Center Orange, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital-Torrington Care Center Torrington, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital-Waterbury Care Center Waterbury, Connecticut Site Public Contact - (canceranswers@yale.edu)
Southeast Cancer Center Cape Girardeau, Missouri
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)
Southpointe-Sanford Medical Center Fargo Fargo, North Dakota
Southwest Oncology PC Durango, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Springfield Clinic Springfield, Illinois
Springfield Regional Cancer Center Springfield, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Springfield Regional Medical Center Springfield, Ohio Site Public Contact - (Jeffh@columbusccop.org)
State University of New York Upstate Medical University Syracuse, New York
Stony Brook University Medical Center Stony Brook, New York
Strecker Cancer Center-Belpre Belpre, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Sutter Auburn Faith Hospital Auburn, California Site Public Contact - (NCIclinicaltrials@sutterhealth.org)
Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn, California Site Public Contact - (NCIclinicaltrials@sutterhealth.org)
Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park, California Site Public Contact - (NCIclinicaltrials@sutterhealth.org)
Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville, California Site Public Contact - (NCIclinicaltrials@sutterhealth.org)
Sutter Cancer Research Consortium Novato, California Site Public Contact - (NCIclinicaltrials@sutterhealth.org)
Sutter Davis Hospital Davis, California Site Public Contact - (NCIclinicaltrials@sutterhealth.org)
Sutter Medical Center Sacramento Sacramento, California Site Public Contact - (NCIclinicaltrials@sutterhealth.org)
Sutter Pacific Medical Foundation Santa Rosa, California Site Public Contact - (NCIclinicaltrials@sutterhealth.org)
Sutter Roseville Medical Center Roseville, California Site Public Contact - (NCIclinicaltrials@sutterhealth.org)
Sutter Solano Medical Center/Cancer Center Vallejo, California Site Public Contact - (NCIclinicaltrials@sutterhealth.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-Ballard Campus Seattle, Washington Site Public Contact - (PCRC-NCORP@Swedish.org)
Swedish Medical Center-Cherry Hill Seattle, Washington Site Public Contact - (PCRC-NCORP@Swedish.org)
Swedish Medical Center-First Hill Seattle, Washington Site Public Contact - (PCRC-NCORP@Swedish.org)
The Carle Foundation Hospital Urbana, Illinois Site Public Contact - (Research@carle.com)
The Hospital of Central Connecticut New Britain, Connecticut
The Mark H Zangmeister Center Columbus, Ohio Site Public Contact - (Jeffh@columbusccop.org)
ThedaCare Regional Cancer Center Appleton, Wisconsin Site Public Contact - (ResearchDept@thedacare.org)
ThedaCare Regional Medical Center - Neenah Neenah, Wisconsin Site Public Contact - (ResearchDept@thedacare.org)
Thomas Jefferson University Hospital Philadelphia, Pennsylvania Site Public Contact - (ONCTrialNow@jefferson.edu)
TidalHealth Nanticoke / Allen Cancer Center Seaford, Delaware
Toledo Clinic Cancer Centers-Maumee Maumee, Ohio Site Public Contact - (pshoup@toledoclinic.com)
Toledo Clinic Cancer Centers-Monroe Monroe, Michigan
Toledo Clinic Cancer Centers-Toledo Toledo, Ohio
TriHealth Cancer Institute-Anderson Cincinnati, Ohio Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
TriHealth Cancer Institute-Westside Cincinnati, Ohio Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Trinity Health Grand Rapids Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health 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)
Trinity Regional Medical Center Fort Dodge, Iowa
Tufts Medical Center Boston, Massachusetts Site Public Contact - (ContactUsCancerCenter@TuftsMedicalCenter.org)
UH Seidman Cancer Center at Landerbrook Health Center Mayfield Heights, Ohio
UH Seidman Cancer Center at Saint John Medical Center Westlake, Ohio
UHHS-Chagrin Highlands Medical Center Beachwood, Ohio
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)
Unity Hospital Fridley, Minnesota
University Hospitals Parma Medical Center Parma, Ohio
University Hospitals Sharon Health Center Wadsworth, Ohio
University of Arizona Cancer Center-North Campus Tucson, Arizona Site Public Contact - (UACC-IIT@uacc.arizona.edu)
University of Arizona Cancer Center-Orange Grove Campus Tucson, Arizona
University of Cincinnati Cancer Center-UC Medical Center Cincinnati, Ohio Site Public Contact - (cancer@uchealth.com)
University of Cincinnati Cancer Center-West Chester West Chester, Ohio Site Public Contact - (cancer@uchealth.com)
University of Illinois Chicago, Illinois
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 Rochester Rochester, New York
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)
UofL Health Medical Center Northeast Louisville, Kentucky
Upper Valley Medical Center Troy, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
VCU Community Memorial Health Center South Hill, Virginia
Valley Radiation Oncology Peru, Illinois
Vanderbilt University/Ingram Cancer Center Nashville, Tennessee
Vince Lombardi Cancer Clinic - Oshkosh Oshkosh, Wisconsin Site Public Contact - (ncorp@aurora.org)
Vince Lombardi Cancer Clinic-Sheboygan Sheboygan, Wisconsin Site Public Contact - (ncorp@aurora.org)
Vince Lombardi Cancer Clinic-Two Rivers Two Rivers, Wisconsin Site Public Contact - (ncorp@aurora.org)
Virginia Cancer Institute Richmond, Virginia
Virginia Commonwealth University/Massey Cancer Center Richmond, Virginia
Walter Knox Memorial Hospital Emmett, Idaho Site Public Contact - (stephanie.couch@stjoeshealth.org)
Wayne Hospital Greenville, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Welch Cancer Center Sheridan, Wyoming Site Public Contact - (mccinfo@mtcancer.org)
West Michigan Cancer Center Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
West Virginia University Charleston Division Charleston, West Virginia
Western Illinois Cancer Treatment Center Galesburg, Illinois
William S Middleton VA Medical Center Madison, Wisconsin
Woodland Memorial Hospital Woodland, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Yale University New Haven, Connecticut Site Public Contact - (canceranswers@yale.edu)
Yale-New Haven Hospital North Haven Medical Center North Haven, Connecticut Site Public Contact - (canceranswers@yale.edu)
Zangmeister Center Grove City Grove City, Ohio Site Public Contact - (Jeffh@columbusccop.org)