RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 3 Randomized Trial for Patients With De Novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 With GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients With FLT3 Mutations

Quick Facts

Study Start:2020-07-21

Study Completion:2027-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04293562

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Todd M Cooper

PRINCIPAL_INVESTIGATOR

Children's Oncology Group

Study Locations (Sites)

Children's Hospital of Alabama

Birmingham, Alabama, 35233

United States

USA Health Strada Patient Care Center

Mobile, Alabama, 36604

United States

Banner Children's at Desert

Mesa, Arizona, 85202

United States

Phoenix Childrens Hospital

Phoenix, Arizona, 85016

United States

Banner University Medical Center - Tucson

Tucson, Arizona, 85719

United States

Arkansas Children's Hospital

Little Rock, Arkansas, 72202-3591

United States

Kaiser Permanente Downey Medical Center

Downey, California, 90242

United States

City of Hope Comprehensive Cancer Center

Duarte, California, 91010

United States

Loma Linda University Medical Center

Loma Linda, California, 92354

United States

Miller Children's and Women's Hospital Long Beach

Long Beach, California, 90806

United States

Children's Hospital Los Angeles

Los Angeles, California, 90027

United States

Cedars Sinai Medical Center

Los Angeles, California, 90048

United States

Mattel Children's Hospital UCLA

Los Angeles, California, 90095

United States

Valley Children's Hospital

Madera, California, 93636

United States

UCSF Benioff Children's Hospital Oakland

Oakland, California, 94609

United States

Kaiser Permanente-Oakland

Oakland, California, 94611

United States

Children's Hospital of Orange County

Orange, California, 92868

United States

Lucile Packard Children's Hospital Stanford University

Palo Alto, California, 94304

United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817

United States

Rady Children's Hospital - San Diego

San Diego, California, 92123

United States

UCSF Medical Center-Mission Bay

San Francisco, California, 94158

United States

Santa Barbara Cottage Hospital

Santa Barbara, California, 93102

United States

Children's Hospital Colorado

Aurora, Colorado, 80045

United States

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

Denver, Colorado, 80218

United States

Connecticut Children's Medical Center

Hartford, Connecticut, 06106

United States

Yale University

New Haven, Connecticut, 06520

United States

Alfred I duPont Hospital for Children

Wilmington, Delaware, 19803

United States

MedStar Georgetown University Hospital

Washington, District of Columbia, 20007

United States

Children's National Medical Center

Washington, District of Columbia, 20010

United States

Broward Health Medical Center

Fort Lauderdale, Florida, 33316

United States

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, 33908

United States

University of Florida Health Science Center - Gainesville

Gainesville, Florida, 32610

United States

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021

United States

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, 32207

United States

Palms West Radiation Therapy

Loxahatchee Groves, Florida, 33470

United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136

United States

Nicklaus Children's Hospital

Miami, Florida, 33155

United States

AdventHealth Orlando

Orlando, Florida, 32803

United States

Arnold Palmer Hospital for Children

Orlando, Florida, 32806

United States

Nemours Children's Hospital

Orlando, Florida, 32827

United States

Sacred Heart Hospital

Pensacola, Florida, 32504

United States

Johns Hopkins All Children's Hospital

Saint Petersburg, Florida, 33701

United States

Tampa General Hospital

Tampa, Florida, 33606

United States

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

Tampa, Florida, 33607

United States

Saint Mary's Medical Center

West Palm Beach, Florida, 33407

United States

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Atlanta, Georgia, 30329

United States

Augusta University Medical Center

Augusta, Georgia, 30912

United States

Memorial Health University Medical Center

Savannah, Georgia, 31404

United States

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826

United States

Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712

United States

Lurie Children's Hospital-Chicago

Chicago, Illinois, 60611

United States

University of Illinois

Chicago, Illinois, 60612

United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637

United States

Loyola University Medical Center

Maywood, Illinois, 60153

United States

Advocate Children's Hospital-Oak Lawn

Oak Lawn, Illinois, 60453

United States

Advocate Children's Hospital-Park Ridge

Park Ridge, Illinois, 60068

United States

Saint Jude Midwest Affiliate

Peoria, Illinois, 61637

United States

Southern Illinois University School of Medicine

Springfield, Illinois, 62702

United States

Riley Hospital for Children

Indianapolis, Indiana, 46202

United States

Ascension Saint Vincent Indianapolis Hospital

Indianapolis, Indiana, 46260

United States

Blank Children's Hospital

Des Moines, Iowa, 50309

United States

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242

United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536

United States

Norton Children's Hospital

Louisville, Kentucky, 40202

United States

Children's Hospital New Orleans

New Orleans, Louisiana, 70118

United States

Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121

United States

Eastern Maine Medical Center

Bangor, Maine, 04401

United States

Maine Children's Cancer Program

Scarborough, Maine, 04074

United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201

United States

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215

United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287

United States

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889-5600

United States

Tufts Children's Hospital

Boston, Massachusetts, 02111

United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114

United States

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

United States

UMass Memorial Medical Center - University Campus

Worcester, Massachusetts, 01655

United States

C S Mott Children's Hospital

Ann Arbor, Michigan, 48109

United States

Children's Hospital of Michigan

Detroit, Michigan, 48201

United States

Henry Ford Health Saint John Hospital

Detroit, Michigan, 48236

United States

Michigan State University Clinical Center

East Lansing, Michigan, 48824

United States

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

Grand Rapids, Michigan, 49503

United States

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007

United States

Corewell Health Children's

Royal Oak, Michigan, 48073

United States

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, 55404

United States

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455

United States

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

University of Mississippi Medical Center

Jackson, Mississippi, 39216

United States

University of Missouri Children's Hospital

Columbia, Missouri, 65212

United States

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108

United States

Cardinal Glennon Children's Medical Center

Saint Louis, Missouri, 63104

United States

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

Mercy Hospital Saint Louis

Saint Louis, Missouri, 63141

United States

Children's Hospital and Medical Center of Omaha

Omaha, Nebraska, 68114

United States

University of Nebraska Medical Center

Omaha, Nebraska, 68198

United States

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102

United States

Sunrise Hospital and Medical Center

Las Vegas, Nevada, 89109

United States

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Las Vegas, Nevada, 89135

United States

Summerlin Hospital Medical Center

Las Vegas, Nevada, 89144

United States

Renown Regional Medical Center

Reno, Nevada, 89502

United States

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 03756

United States

Hackensack University Medical Center

Hackensack, New Jersey, 07601

United States

Morristown Medical Center

Morristown, New Jersey, 07960

United States

Saint Peter's University Hospital

New Brunswick, New Jersey, 08901

United States

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

New Brunswick, New Jersey, 08903

United States

Newark Beth Israel Medical Center

Newark, New Jersey, 07112

United States

Saint Joseph's Regional Medical Center

Paterson, New Jersey, 07503

United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106

United States

Albany Medical Center

Albany, New York, 12208

United States

Montefiore Medical Center - Moses Campus

Bronx, New York, 10467

United States

Maimonides Medical Center

Brooklyn, New York, 11219

United States

Roswell Park Cancer Institute

Buffalo, New York, 14263

United States

NYU Langone Hospital - Long Island

Mineola, New York, 11501

United States

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

New Hyde Park, New York, 11040

United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016

United States

Mount Sinai Hospital

New York, New York, 10029

United States

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

New York, New York, 10032

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

NYP/Weill Cornell Medical Center

New York, New York, 10065

United States

University of Rochester

Rochester, New York, 14642

United States

Stony Brook University Medical Center

Stony Brook, New York, 11794

United States

State University of New York Upstate Medical University

Syracuse, New York, 13210

United States

New York Medical College

Valhalla, New York, 10595

United States

Mission Hospital

Asheville, North Carolina, 28801

United States

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599

United States

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203

United States

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, 28204

United States

Duke University Medical Center

Durham, North Carolina, 27710

United States

East Carolina University

Greenville, North Carolina, 27834

United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157

United States

Sanford Broadway Medical Center

Fargo, North Dakota, 58122

United States

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

United States

Rainbow Babies and Childrens Hospital

Cleveland, Ohio, 44106

United States

Cleveland Clinic Foundation

Cleveland, Ohio, 44195

United States

Nationwide Children's Hospital

Columbus, Ohio, 43205

United States

Dayton Children's Hospital

Dayton, Ohio, 45404

United States

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

Toledo, Ohio, 43606

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

United States

Legacy Emanuel Children's Hospital

Portland, Oregon, 97227

United States

Oregon Health and Science University

Portland, Oregon, 97239

United States

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, 18103

United States

Geisinger Medical Center

Danville, Pennsylvania, 17822

United States

Penn State Children's Hospital

Hershey, Pennsylvania, 17033

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

United States

Saint Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19134

United States

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224

United States

Rhode Island Hospital

Providence, Rhode Island, 02903

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Prisma Health Richland Hospital

Columbia, South Carolina, 29203

United States

BI-LO Charities Children's Cancer Center

Greenville, South Carolina, 29605

United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134

United States

T C Thompson Children's Hospital

Chattanooga, Tennessee, 37403

United States

East Tennessee Childrens Hospital

Knoxville, Tennessee, 37916

United States

The Children's Hospital at TriStar Centennial

Nashville, Tennessee, 37203

United States

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232

United States

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723

United States

Driscoll Children's Hospital

Corpus Christi, Texas, 78411

United States

Medical City Dallas Hospital

Dallas, Texas, 75230

United States

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390

United States

El Paso Children's Hospital

El Paso, Texas, 79905

United States

Cook Children's Medical Center

Fort Worth, Texas, 76104

United States

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030

United States

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Children's Hospital of San Antonio

San Antonio, Texas, 78207

United States

Methodist Children's Hospital of South Texas

San Antonio, Texas, 78229

United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229

United States

Scott and White Memorial Hospital

Temple, Texas, 76508

United States

Primary Children's Hospital

Salt Lake City, Utah, 84113

United States

University of Vermont and State Agricultural College

Burlington, Vermont, 05405

United States

University of Virginia Cancer Center

Charlottesville, Virginia, 22908

United States

Inova Fairfax Hospital

Falls Church, Virginia, 22042

United States

Children's Hospital of The King's Daughters

Norfolk, Virginia, 23507

United States

Naval Medical Center - Portsmouth

Portsmouth, Virginia, 23708-2197

United States

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298

United States

Carilion Children's

Roanoke, Virginia, 24014

United States

Seattle Children's Hospital

Seattle, Washington, 98105

United States

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, 99204

United States

Mary Bridge Children's Hospital and Health Center

Tacoma, Washington, 98405

United States

Madigan Army Medical Center

Tacoma, Washington, 98431

United States

West Virginia University Charleston Division

Charleston, West Virginia, 25304

United States

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301

United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792

United States

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449

United States

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Children's Oncology Group

Todd M Cooper, PRINCIPAL_INVESTIGATOR, Children's Oncology Group

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-21

Study Completion Date2027-09-30

Study Record Updates

Study Start Date2020-07-21

Study Completion Date2027-09-30

Terms related to this study

Additional Relevant MeSH Terms

Acute Myeloid Leukemia