Recruiting
Phase 3

CPX-351 & Gilteritinib

Sponsor:

Children's Oncology Group

Code:

NCT04293562

Conditions

Acute Myeloid Leukemia

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Interventions

Allogeneic Hematopoietic Stem Cell Transplantation

Asparaginase Erwinia chrysanthemi

Biospecimen Collection

Bone Marrow Aspiration

Bone Marrow Biopsy

Study Details

Brief summary:

This phase III trial compares standard chemotherapy to therapy with liposome-encapsulated daunorubicin-cytarabine (CPX-351) and/or gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without FLT3 mutations. Drugs used in chemotherapy, such as daunorubicin, cytarabine, and gemtuzumab ozogamicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. CPX-351 is made up of daunorubicin and cytarabine and is made in a way that makes the drugs stay in the bone marrow longer and could be less likely to cause heart problems than traditional anthracycline drugs, a common class of chemotherapy drug. Some acute myeloid leukemia patients have an abnormality in the structure of a gene called FLT3. Genes are pieces of DNA (molecules that carry instructions for development, functioning, growth and reproduction) inside each cell that tell the cell what to do and when to grow and divide. FLT3 plays an important role in the normal making of blood cells. This gene can have permanent changes that cause it to function abnormally by making cancer cells grow. Gilteritinib may block the abnormal function of the FLT3 gene that makes cancer cells grow. The overall goals of this study are, 1) to compare the effects, good and/or bad, of CPX-351 with daunorubicin and cytarabine on people with newly diagnosed AML to find out which is better, 2) to study the effects, good and/or bad, of adding gilteritinib to AML therapy for patients with high amounts of FLT3/ITD or other FLT3 mutations and 3) to study changes in heart function during and after treatment for AML. Giving CPX-351 and/or gilteritinib with standard chemotherapy may work better in treating patients with acute myeloid leukemia compared to standard chemotherapy alone.

Conditions

Acute Myeloid Leukemia

Study ID

NCT04293562

Start date

Jul 21, 2020

Status verified date

Jul, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Jun 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1186 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A High Risk Group

Arm A High Risk Group: See Detailed Description.

experimental: Arm A Low Risk Group 1

Arm A Low Risk Group 1: See Detailed Description. (CLOSED TO ACCRUAL 11/19/2024)

experimental: Arm A Low Risk Group 2

Arm A Low Risk Group 2: See Detailed Description.

experimental: Arm AC High Risk Group

Arm AC High Risk Group: See Detailed Description.

experimental: Arm AC Low Risk Group 2

Arm AC Low Risk Group 2: See Detailed Description.

experimental: Arm AD High Risk Group

Arm AD High Risk Group: See Detailed Description.

experimental: Arm AD Low Risk Group 2

Arm AD Low Risk Group 2: See Detailed Description.

experimental: Arm B High Risk Group

Arm B High Risk Group: See Detailed Description. (CLOSED TO ACCRUAL 11/19/2024)

experimental: Arm B Low Risk Group 1

Arm B Low Risk Group 1: See Detailed Description. (CLOSED TO ACCRUAL 11/19/2024)

experimental: Arm B Low Risk Group 2

Arm B Low Risk Group 2: See Detailed Description. (CLOSED TO ACCRUAL 11/19/2024)

experimental: Arm BC High Risk Group

Arm BC High Risk Group: See Detailed Description. (CLOSED TO ACCRUAL 11/19/2024)

experimental: Arm BC Low Risk Group 2

Arm BC Low Risk Group 2: See Detailed Description. (CLOSED TO ACCRUAL 11/19/2024)

experimental: Arm BD High Risk Group

Arm BD High Risk Group: See Detailed Description. (CLOSED TO ACCRUAL 11/19/2024)

experimental: Arm BD Low Risk Group 2

Arm BD Low Risk Group 2: See Detailed Description. (CLOSED TO ACCRUAL 11/19/2024)

Interventions

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo allogeneic HSCT

Asparaginase Erwinia chrysanthemi

Given IM or IV

Biospecimen Collection

Undergo blood sample collection

Bone Marrow Aspiration

Undergo BM aspiration

Bone Marrow Biopsy

BM biopsy

Computed Tomography

Undergo CT

Cytarabine

Given IV or IT

Daunorubicin Hydrochloride

Given IV

Dexrazoxane Hydrochloride

Given IV

Etoposide

Given IV

Fludeoxyglucose F-18

Undergo FDG-PET

Gemtuzumab Ozogamicin

Given IV

Gilteritinib Fumarate

Given PO/NG/G-tube

Liposome-encapsulated Daunorubicin-Cytarabine

Given IV

Magnetic Resonance Imaging

Undergo MRI

Methotrexate

Given IT

Mitoxantrone Hydrochloride

Given IV

Positron Emission Tomography

Undergo FDG-PET

Questionnaire Administration

Ancillary studies

Therapeutic Hydrocortisone

Given IT

Primary outcome measure

  • Event-free survival (EFS) [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Locations

Children's Hospital of Alabama

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Principal Investigator:

Matthew A. Kutny

USA Health Strada Patient Care Center

Recruiting

Mobile, Alabama, United States, 36604

Contacts

Site Public Contact

800-388-8721

Principal Investigator:

Hamayun Imran

Banner Children's at Desert

Recruiting

Mesa, Arizona, United States, 85202

Contacts

Site Public Contact

480-412-3100

Principal Investigator:

Joseph C. Torkildson

Phoenix Childrens Hospital

Recruiting

Phoenix, Arizona, United States, 85016

Contacts

Site Public Contact

602-546-0920

Principal Investigator:

Laura L. Retson

Banner University Medical Center - Tucson

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Site Public Contact

UACC-IIT@uacc.arizona.edu

Principal Investigator:

Monica M. Davini

Arkansas Children's Hospital

Recruiting

Little Rock, Arkansas, United States, 72202-3591

Contacts

Site Public Contact

501-364-7373

Principal Investigator:

Michael W. Bishop

Kaiser Permanente Downey Medical Center

Recruiting

Downey, California, United States, 90242

Contacts

Site Public Contact

626-564-3455

Principal Investigator:

Robert M. Cooper

City of Hope Comprehensive Cancer Center

Recruiting

Duarte, California, United States, 91010

Contacts

Principal Investigator:

Anna B. Pawlowska

Loma Linda University Medical Center

Recruiting

Loma Linda, California, United States, 92354

Contacts

Site Public Contact

909-558-4050

Principal Investigator:

Albert Kheradpour

Miller Children's and Women's Hospital Long Beach

Recruiting

Long Beach, California, United States, 90806

Contacts

Site Public Contact

562-933-5600

Principal Investigator:

Jacqueline N. Casillas

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Site Public Contact

323-361-4110

Principal Investigator:

Etan Orgel

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Principal Investigator:

Fataneh (Fae) Majlessipour

Mattel Children's Hospital UCLA

Recruiting

Los Angeles, California, United States, 90095

Contacts

Site Public Contact

310-825-6708

Principal Investigator:

Satiro N. De Oliveira

Valley Children's Hospital

Recruiting

Madera, California, United States, 93636

Contacts

Principal Investigator:

Ruetima Titapiwatanakun

UCSF Benioff Children's Hospital Oakland

Recruiting

Oakland, California, United States, 94609

Contacts

Principal Investigator:

Jennifer G. Michlitsch

Kaiser Permanente-Oakland

Recruiting

Oakland, California, United States, 94611

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Aarati V. Rao

Children's Hospital of Orange County

Recruiting

Orange, California, United States, 92868

Contacts

Principal Investigator:

Elyssa M. Rubin

Lucile Packard Children's Hospital Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Principal Investigator:

Jay Michael S. Balagtas

University of California Davis Comprehensive Cancer Center

Recruiting

Sacramento, California, United States, 95817

Contacts

Site Public Contact

916-734-3089

Principal Investigator:

Marcio H. Malogolowkin

Rady Children's Hospital - San Diego

Recruiting

San Diego, California, United States, 92123

Contacts

Site Public Contact

858-966-5934

Principal Investigator:

William D. Roberts

UCSF Medical Center-Mission Bay

Recruiting

San Francisco, California, United States, 94158

Contacts

Principal Investigator:

Benjamin J. Huang

Santa Barbara Cottage Hospital

Recruiting

Santa Barbara, California, United States, 93102

Contacts

Site Public Contact

805-682-7300

Principal Investigator:

Shivani Upadhyay

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Principal Investigator:

Kelly W. Maloney

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

Recruiting

Denver, Colorado, United States, 80218

Contacts

Principal Investigator:

Florence Choo

Connecticut Children's Medical Center

Recruiting

Hartford, Connecticut, United States, 06106

Contacts

Site Public Contact

860-545-9981

Principal Investigator:

Michael S. Isakoff

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Principal Investigator:

Farzana Pashankar

Alfred I duPont Hospital for Children

Recruiting

Wilmington, Delaware, United States, 19803

Contacts

Principal Investigator:

Emi H. Caywood

MedStar Georgetown University Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20007

Contacts

Site Public Contact

202-444-2223

Principal Investigator:

Caileigh Pudela

Children's National Medical Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Principal Investigator:

Jeffrey S. Dome

Golisano Children's Hospital of Southwest Florida

Recruiting

Fort Myers, Florida, United States, 33908

Contacts

Principal Investigator:

Emad K. Salman

UF Health Cancer Institute - Gainesville

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Principal Investigator:

Brian Stover

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Recruiting

Hollywood, Florida, United States, 33021

Contacts

Site Public Contact

954-265-1847OHR@mhs.net

Principal Investigator:

Iftikhar Hanif

Nemours Children's Clinic-Jacksonville

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

Principal Investigator:

Emi H. Caywood

University of Miami Miller School of Medicine-Sylvester Cancer Center

Recruiting

Miami, Florida, United States, 33136

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

Julio C. Barredo

Nicklaus Children's Hospital

Recruiting

Miami, Florida, United States, 33155

Contacts

Site Public Contact

888-624-2778

Principal Investigator:

Maggie E. Fader

AdventHealth Orlando

Recruiting

Orlando, Florida, United States, 32803

Contacts

Principal Investigator:

Fouad M. Hajjar

Arnold Palmer Hospital for Children

Recruiting

Orlando, Florida, United States, 32806

Contacts

Principal Investigator:

Jaime M. Libes-Bander

Nemours Children's Hospital

Recruiting

Orlando, Florida, United States, 32827

Contacts

Principal Investigator:

Emi H. Caywood

Nemours Children's Clinic - Pensacola

Recruiting

Pensacola, Florida, United States, 32504

Contacts

Principal Investigator:

Jeffrey H. Schwartz

Johns Hopkins All Children's Hospital

Recruiting

St. Petersburg, Florida, United States, 33701

Contacts

Principal Investigator:

Jennifer L. Mayer

Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606

Contacts

Principal Investigator:

Andrew J. Galligan

Saint Joseph's Hospital/Children's Hospital-Tampa

Recruiting

Tampa, Florida, United States, 33607

Contacts

Principal Investigator:

Don E. Eslin

Saint Mary's Medical Center

Recruiting

West Palm Beach, Florida, United States, 33407

Contacts

Site Public Contact

561-822-4745

Principal Investigator:

Matthew D. Ramirez

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Principal Investigator:

Himalee S. Sabnis

Augusta University Medical Center

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Principal Investigator:

Colleen H. McDonough

Memorial Health University Medical Center

Recruiting

Savannah, Georgia, United States, 31404

Contacts

Principal Investigator:

Andrew L. Pendleton

Kapiolani Medical Center for Women and Children

Recruiting

Honolulu, Hawaii, United States, 96826

Contacts

Site Public Contact

808-983-6090

Principal Investigator:

Wade T. Kyono

Saint Luke's Cancer Institute - Boise

Recruiting

Boise, Idaho, United States, 83712

Contacts

Principal Investigator:

Martha M. Pacheco

Lurie Children's Hospital-Chicago

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Site Public Contact

773-880-4562

Principal Investigator:

Jenna Rossoff

University of Illinois

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Site Public Contact

312-355-3046

Principal Investigator:

Dipti S. Dighe

University of Chicago Comprehensive Cancer Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Principal Investigator:

Gabrielle Lapping-Carr

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Site Public Contact

708-226-4357

Principal Investigator:

Eugene Suh

Advocate Children's Hospital-Oak Lawn

Recruiting

Oak Lawn, Illinois, United States, 60453

Contacts

Site Public Contact

847-723-7570

Principal Investigator:

Rebecca E. McFall

Advocate Children's Hospital-Park Ridge

Recruiting

Park Ridge, Illinois, United States, 60068

Contacts

Principal Investigator:

Rebecca E. McFall

OSF Children's Hospital of Illinois

Recruiting

Peoria, Illinois, United States, 61637

Contacts

Principal Investigator:

Prerna Kumar

Southern Illinois University School of Medicine

Recruiting

Springfield, Illinois, United States, 62702

Contacts

Site Public Contact

217-545-7929

Principal Investigator:

Gregory P. Brandt

Riley Hospital for Children

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Site Public Contact

800-248-1199

Principal Investigator:

Sandeep Batra

Ascension Saint Vincent Indianapolis Hospital

Recruiting

Indianapolis, Indiana, United States, 46260

Contacts

Principal Investigator:

Bassem I. Razzouk

Blank Children's Hospital

Recruiting

Des Moines, Iowa, United States, 50309

Contacts

Principal Investigator:

Samantha L. Mallory

University of Iowa/Holden Comprehensive Cancer Center

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Site Public Contact

800-237-1225

Principal Investigator:

Andrew P. Groves

University of Kentucky/Markey Cancer Center

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Site Public Contact

859-257-3379

Principal Investigator:

James T. Badgett

Norton Children's Hospital

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Principal Investigator:

Michael J. Ferguson

Children's Hospital New Orleans

Recruiting

New Orleans, Louisiana, United States, 70118

Contacts

Site Public Contact

504-894-5377

Principal Investigator:

Maria C. Velez-Yanguas

Ochsner Medical Center Jefferson

Recruiting

New Orleans, Louisiana, United States, 70121

Contacts

Principal Investigator:

Craig Lotterman

Eastern Maine Medical Center

Recruiting

Bangor, Maine, United States, 04401

Contacts

Site Public Contact

207-973-4274

Principal Investigator:

Daniel L. Callaway

Maine Children's Cancer Program

Recruiting

Scarborough, Maine, United States, 04074

Contacts

Principal Investigator:

Eric C. Larsen

University of Maryland/Greenebaum Cancer Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Site Public Contact

800-888-8823

Principal Investigator:

Teresa A. York

Sinai Hospital of Baltimore

Recruiting

Baltimore, Maryland, United States, 21215

Contacts

Site Public Contact

410-601-9083

Principal Investigator:

Jason M. Fixler

Johns Hopkins University/Sidney Kimmel Cancer Center

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Principal Investigator:

Alan D. Friedman

Walter Reed National Military Medical Center

Recruiting

Bethesda, Maryland, United States, 20889-5600

Contacts

Site Public Contact

301-319-2100

Principal Investigator:

Kip R. Hartman

Massachusetts General Hospital Cancer Center

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Site Public Contact

877-726-5130

Principal Investigator:

Alison M. Friedmann

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Site Public Contact

877-442-3324

Principal Investigator:

Jessica A. Pollard

UMass Memorial Medical Center - University Campus

Recruiting

Worcester, Massachusetts, United States, 01655

Contacts

Principal Investigator:

Stefanie R. Lowas

C S Mott Children's Hospital

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Site Public Contact

800-865-1125

Principal Investigator:

Joshua W. Goldman

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Principal Investigator:

Kathleen Y. Butler

Bronson Methodist Hospital

Recruiting

Kalamazoo, Michigan, United States, 49007

Contacts

Principal Investigator:

Kathleen Y. Butler

Corewell Health Children's

Recruiting

Royal Oak, Michigan, United States, 48073

Contacts

Site Public Contact

248-551-7695

Principal Investigator:

Marie V. Nelson

Children's Hospitals and Clinics of Minnesota - Minneapolis

Recruiting

Minneapolis, Minnesota, United States, 55404

Contacts

Principal Investigator:

Michael K. Richards

University of Minnesota/Masonic Cancer Center

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Site Public Contact

612-624-2620

Principal Investigator:

Peter M. Gordon

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Site Public Contact

855-776-0015

Principal Investigator:

Mira Kohorst

University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

Contacts

Site Public Contact

601-815-6700

Principal Investigator:

Amanda Strobel

Children's Mercy Hospitals and Clinics

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Principal Investigator:

Keith J. August

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Principal Investigator:

Shalini Shenoy

Mercy Hospital Saint Louis

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Site Public Contact

314-251-7066

Principal Investigator:

Robin D. Hanson

Children's Hospital and Medical Center of Omaha

Recruiting

Omaha, Nebraska, United States, 68114

Contacts

Site Public Contact

402-955-3949

Principal Investigator:

Jill C. Beck

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Principal Investigator:

Jill C. Beck

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Recruiting

Las Vegas, Nevada, United States, 89135

Contacts

Principal Investigator:

Alan K. Ikeda

Summerlin Hospital Medical Center

Recruiting

Las Vegas, Nevada, United States, 89144

Contacts

Principal Investigator:

Alan K. Ikeda

Renown Regional Medical Center

Recruiting

Reno, Nevada, United States, 89502

Contacts

Principal Investigator:

Alan K. Ikeda

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Principal Investigator:

Angela Ricci

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Site Public Contact

551-996-2897

Principal Investigator:

Jing Chen

Morristown Medical Center

Recruiting

Morristown, New Jersey, United States, 07960

Contacts

Site Public Contact

973-971-5900

Principal Investigator:

Kathryn L. Laurie

Saint Peter's University Hospital

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Principal Investigator:

Nibal A. Zaghloul

Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

Recruiting

New Brunswick, New Jersey, United States, 08903

Contacts

Site Public Contact

732-235-8675

Principal Investigator:

Marissa Botwinick

Newark Beth Israel Medical Center

Recruiting

Newark, New Jersey, United States, 07112

Contacts

Principal Investigator:

Teena Bhatla

Saint Joseph's Regional Medical Center

Recruiting

Paterson, New Jersey, United States, 07503

Contacts

Site Public Contact

973-754-2207HallL@sjhmc.org

Principal Investigator:

Alissa Kahn

Albany Medical Center

Recruiting

Albany, New York, United States, 12208

Contacts

Site Public Contact

518-262-5513

Principal Investigator:

Lauren R. Weintraub

Maimonides Medical Center

Recruiting

Brooklyn, New York, United States, 11219

Contacts

Site Public Contact

718-765-2500

Principal Investigator:

Mahmut Y. Celiker

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Principal Investigator:

Clare J. Twist

NYU Langone Hospital - Long Island

Recruiting

Mineola, New York, United States, 11501

Contacts

Principal Investigator:

Chana L. Glasser

The Steven and Alexandra Cohen Children's Medical Center of New York

Recruiting

New Hyde Park, New York, United States, 11040

Contacts

Site Public Contact

718-470-3460

Principal Investigator:

Arlene S. Redner

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

Recruiting

New York, New York, United States, 10032

Contacts

Principal Investigator:

Nobuko Hijiya

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Maria Luisa Sulis

NYP/Weill Cornell Medical Center

Recruiting

New York, New York, United States, 10065

Contacts

Site Public Contact

212-746-1848

Principal Investigator:

Alexander J. Chou

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Site Public Contact

585-275-5830

Principal Investigator:

Rafi R. Kazi

Stony Brook University Medical Center

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Site Public Contact

800-862-2215

Principal Investigator:

Laura E. Hogan

State University of New York Upstate Medical University

Recruiting

Syracuse, New York, United States, 13210

Contacts

Site Public Contact

315-464-5476

Principal Investigator:

Melanie A. Comito

Montefiore Medical Center - Moses Campus

Recruiting

The Bronx, New York, United States, 10467

Contacts

Principal Investigator:

Alice Lee

New York Medical College

Recruiting

Valhalla, New York, United States, 10595

Contacts

Site Public Contact

914-594-3794

Principal Investigator:

Andrew J. Bellantoni

Mission Hospital

Recruiting

Asheville, North Carolina, United States, 28801

Contacts

Principal Investigator:

Douglas J. Scothorn

UNC Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Principal Investigator:

Thomas B. Alexander

Novant Health Presbyterian Medical Center

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Principal Investigator:

Holly Edington

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Site Public Contact

888-275-3853

Principal Investigator:

Jessica M. Sun

East Carolina University

Recruiting

Greenville, North Carolina, United States, 27834

Contacts

Principal Investigator:

Andrea R. Whitfield

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Site Public Contact

336-713-6771

Principal Investigator:

Sarah Supples

Sanford Broadway Medical Center

Recruiting

Fargo, North Dakota, United States, 58122

Contacts

Principal Investigator:

Samuel J. Milanovich

Children's Hospital Medical Center of Akron

Recruiting

Akron, Ohio, United States, 44308

Contacts

Site Public Contact

330-543-3193

Principal Investigator:

Erin Wright

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Principal Investigator:

Lauren Pommert

Rainbow Babies and Childrens Hospital

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Site Public Contact

216-844-5437

Principal Investigator:

Duncan S. Stearns

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Principal Investigator:

Matteo M. Trucco

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Principal Investigator:

Mark A. Ranalli

Dayton Children's Hospital

Recruiting

Dayton, Ohio, United States, 45404

Contacts

Site Public Contact

800-228-4055

Principal Investigator:

Jordan M. Wright

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

Recruiting

Toledo, Ohio, United States, 43606

Contacts

Principal Investigator:

Jamie L. Dargart

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Principal Investigator:

Rene Y. McNall-Knapp

Legacy Emanuel Children's Hospital

Recruiting

Portland, Oregon, United States, 97227

Contacts

Site Public Contact

503-413-2560

Principal Investigator:

Jason M. Glover

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Site Public Contact

503-494-1080trials@ohsu.edu

Principal Investigator:

Bill H. Chang

Lehigh Valley Hospital-Cedar Crest

Recruiting

Allentown, Pennsylvania, United States, 18103

Contacts

Principal Investigator:

Jacob A. Troutman

Geisinger Medical Center

Recruiting

Danville, Pennsylvania, United States, 17822

Contacts

Principal Investigator:

Jagadeesh Ramdas

Penn State Children's Hospital

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Site Public Contact

717-531-6012

Principal Investigator:

Lisa M. McGregor

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

Richard Aplenc

Saint Christopher's Hospital for Children

Recruiting

Philadelphia, Pennsylvania, United States, 19134

Contacts

Site Public Contact

215-427-8991

Principal Investigator:

Gregory E. Halligan

Children's Hospital of Pittsburgh of UPMC

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Principal Investigator:

Jean M. Tersak

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Site Public Contact

401-444-1488

Principal Investigator:

Bradley DeNardo

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Principal Investigator:

Jacqueline M. Kraveka

Prisma Health Richland Hospital

Recruiting

Columbia, South Carolina, United States, 29203

Contacts

Principal Investigator:

Stuart L. Cramer

BI-LO Charities Children's Cancer Center

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Principal Investigator:

Aniket Saha

Sanford USD Medical Center - Sioux Falls

Recruiting

Sioux Falls, South Dakota, United States, 57117-5134

Contacts

Principal Investigator:

Jordan Fritch-Hanson

East Tennessee Childrens Hospital

Recruiting

Knoxville, Tennessee, United States, 37916

Contacts

Site Public Contact

865-541-8266

Principal Investigator:

Susan E. Spiller

The Children's Hospital at TriStar Centennial

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Site Public Contact

615-342-1919

Principal Investigator:

Clinton M. Carroll

Vanderbilt University/Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Site Public Contact

800-811-8480

Principal Investigator:

Brianna N. Smith

Dell Children's Medical Center of Central Texas

Recruiting

Austin, Texas, United States, 78723

Contacts

Principal Investigator:

Shannon M. Cohn

Driscoll Children's Hospital

Recruiting

Corpus Christi, Texas, United States, 78411

Contacts

Principal Investigator:

Nkechi I. Mba

Medical City Dallas Hospital

Recruiting

Dallas, Texas, United States, 75230

Contacts

Site Public Contact

972-566-5588

Principal Investigator:

Maurizio L. Ghisoli

UT Southwestern/Simmons Cancer Center-Dallas

Recruiting

Dallas, Texas, United States, 75390

Contacts

Principal Investigator:

Tamra L. Slone

El Paso Children's Hospital

Recruiting

El Paso, Texas, United States, 79905

Contacts

Principal Investigator:

Benjamin Carcamo

Cook Children's Medical Center

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Principal Investigator:

Kenneth M. Heym

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Site Public Contact

713-798-1354burton@bcm.edu

Principal Investigator:

Alexandra M. Stevens

UT MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Najat C. Daw

Children's Hospital of San Antonio

Recruiting

San Antonio, Texas, United States, 78207

Contacts

Principal Investigator:

Julie Voeller

Methodist Children's Hospital of South Texas

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Principal Investigator:

Jose M. Esquilin

University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Principal Investigator:

Allison C. Grimes

Scott and White Memorial Hospital

Recruiting

Temple, Texas, United States, 76508

Contacts

Site Public Contact

254-724-5407

Principal Investigator:

Nicholas W. McGregor

Primary Children's Hospital

Recruiting

Salt Lake City, Utah, United States, 84113

Contacts

Site Public Contact

801-585-5270

Principal Investigator:

Mallorie B. Heneghan

University of Vermont and State Agricultural College

Recruiting

Burlington, Vermont, United States, 05405

Contacts

Site Public Contact

802-656-8990rpo@uvm.edu

Principal Investigator:

Jessica L. Heath

University of Virginia Cancer Center

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Principal Investigator:

Brian C. Belyea

Inova Fairfax Hospital

Recruiting

Falls Church, Virginia, United States, 22042

Contacts

Principal Investigator:

Robin Y. Dulman

Children's Hospital of The King's Daughters

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Principal Investigator:

Melissa S. Mark

Naval Medical Center - Portsmouth

Recruiting

Portsmouth, Virginia, United States, 23708-2197

Contacts

Site Public Contact

757-953-5939

Principal Investigator:

Karin Brockman

VCU Massey Comprehensive Cancer Center

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Principal Investigator:

Jordyn R. Griffin

Carilion Children's

Recruiting

Roanoke, Virginia, United States, 24014

Contacts

Principal Investigator:

Erwood G. Edwards

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Site Public Contact

866-987-2000

Principal Investigator:

Sarah E. Leary

Providence Sacred Heart Medical Center and Children's Hospital

Recruiting

Spokane, Washington, United States, 99204

Contacts

Principal Investigator:

Judy L. Felgenhauer

Mary Bridge Children's Hospital and Health Center

Recruiting

Tacoma, Washington, United States, 98405

Contacts

Principal Investigator:

Robert G. Irwin

Madigan Army Medical Center

Recruiting

Tacoma, Washington, United States, 98431

Contacts

Principal Investigator:

Melissa A. Forouhar

West Virginia University Charleston Division

Recruiting

Charleston, West Virginia, United States, 25304

Contacts

Site Public Contact

304-388-9944

Principal Investigator:

Mohamad H. Badawi

Saint Vincent Hospital Cancer Center Green Bay

Recruiting

Green Bay, Wisconsin, United States, 54301

Contacts

Principal Investigator:

Catherine A. Long

University of Wisconsin Carbone Cancer Center - University Hospital

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Principal Investigator:

Cathy A. Lee-Miller

Marshfield Medical Center-Marshfield

Recruiting

Marshfield, Wisconsin, United States, 54449

Contacts

Principal Investigator:

Michelle A. Manalang

Children's Hospital of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Site Public Contact

414-955-4727MACCCTO@mcw.edu

Principal Investigator:

Michael J. Burke

Alberta Children's Hospital

Recruiting

Calgary, Alberta, Canada, T3B 6A8

Contacts

Principal Investigator:

Victor A. Lewis

University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Contacts

Principal Investigator:

Sarah J. McKillop

British Columbia Children's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H 3V4

Contacts

Site Public Contact

604-875-2345

Principal Investigator:

Rebecca J. Deyell

CancerCare Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E 0V9

Contacts

Principal Investigator:

Stephanie M. Villeneuve

IWK Health Centre

Recruiting

Halifax, Nova Scotia, Canada, B3K 6R8

Contacts

Principal Investigator:

Chelsea Ash

McMaster Children's Hospital at Hamilton Health Sciences

Recruiting

Hamilton, Ontario, Canada, L8N 3Z5

Contacts

Site Public Contact

905-521-2100

Principal Investigator:

Uma H. Athale

Kingston Health Sciences Centre

Recruiting

Kingston, Ontario, Canada, K7L 2V7

Contacts

Principal Investigator:

Laura Wheaton

Children's Hospital

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Site Public Contact

519-685-8306

Principal Investigator:

Shayna M. Zelcer

Children's Hospital of Eastern Ontario

Recruiting

Ottawa, Ontario, Canada, K1H 8L1

Contacts

Site Public Contact

613-737-7600

Principal Investigator:

Donna L. Johnston

Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Contacts

Principal Investigator:

Johann Hitzler

The Montreal Children's Hospital of the MUHC

Recruiting

Montreal, Quebec, Canada, H3H 1P3

Contacts

Principal Investigator:

Stephanie Mourad

Centre Hospitalier Universitaire Sainte-Justine

Recruiting

Montreal, Quebec, Canada, H3T 1C5

Contacts

Principal Investigator:

Monia Marzouki

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contacts

Principal Investigator:

Josee Brossard

Jim Pattison Children's Hospital

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 0W8

Contacts

Principal Investigator:

Kathleen Felton

CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)

Recruiting

Québec, Canada, G1V 4G2

Contacts

Principal Investigator:

Bruno Michon

More Information

Sponsor

Children's Oncology Group

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Oncology Group on 2026-07-29.