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

Who is this study for? Child to young adult patients with Acute Myeloid Leukemia
Status: Recruiting
Location: See all (188) locations...
Intervention Type: Procedure, Drug, Behavioral
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 22
Healthy Volunteers: No
View:

• All patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part A) prior to enrollment and treatment on AAML1831. Submission of diagnostic specimens must be done according to the Manual of Procedures

• 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.

Locations
United States
Alabama
Children's Hospital of Alabama
Recruiting
Birmingham
USA Health Strada Patient Care Center
Recruiting
Mobile
Arkansas
Arkansas Children's Hospital
Recruiting
Little Rock
Arizona
Banner Children's at Desert
Recruiting
Mesa
Phoenix Childrens Hospital
Recruiting
Phoenix
Banner University Medical Center - Tucson
Recruiting
Tucson
California
Kaiser Permanente Downey Medical Center
Recruiting
Downey
City of Hope Comprehensive Cancer Center
Recruiting
Duarte
Loma Linda University Medical Center
Recruiting
Loma Linda
Miller Children's and Women's Hospital Long Beach
Recruiting
Long Beach
Cedars Sinai Medical Center
Recruiting
Los Angeles
Children's Hospital Los Angeles
Recruiting
Los Angeles
Mattel Children's Hospital UCLA
Recruiting
Los Angeles
Kaiser Permanente-Oakland
Recruiting
Oakland
UCSF Benioff Children's Hospital Oakland
Recruiting
Oakland
Children's Hospital of Orange County
Recruiting
Orange
University of California Davis Comprehensive Cancer Center
Recruiting
Sacramento
Rady Children's Hospital - San Diego
Recruiting
San Diego
UCSF Medical Center-Mission Bay
Recruiting
San Francisco
Santa Barbara Cottage Hospital
Recruiting
Santa Barbara
Colorado
Children's Hospital Colorado
Recruiting
Aurora
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Recruiting
Denver
Connecticut
Connecticut Children's Medical Center
Recruiting
Hartford
Yale University
Recruiting
New Haven
Washington, D.c.
Children's National Medical Center
Recruiting
Washington
MedStar Georgetown University Hospital
Recruiting
Washington
Delaware
Alfred I duPont Hospital for Children
Recruiting
Wilmington
Florida
Broward Health Medical Center
Recruiting
Fort Lauderdale
Golisano Children's Hospital of Southwest Florida
Recruiting
Fort Myers
University of Florida Health Science Center - Gainesville
Recruiting
Gainesville
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Recruiting
Hollywood
Nemours Children's Clinic-Jacksonville
Recruiting
Jacksonville
Palms West Radiation Therapy
Recruiting
Loxahatchee Groves
Nicklaus Children's Hospital
Recruiting
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Recruiting
Miami
AdventHealth Orlando
Recruiting
Orlando
Arnold Palmer Hospital for Children
Recruiting
Orlando
Nemours Children's Hospital
Recruiting
Orlando
Sacred Heart Hospital
Recruiting
Pensacola
Johns Hopkins All Children's Hospital
Recruiting
Saint Petersburg
Saint Joseph's Hospital/Children's Hospital-Tampa
Recruiting
Tampa
Tampa General Hospital
Recruiting
Tampa
Saint Mary's Hospital
Recruiting
West Palm Beach
Georgia
Children's Healthcare of Atlanta - Egleston
Recruiting
Atlanta
Augusta University Medical Center
Recruiting
Augusta
Memorial Health University Medical Center
Recruiting
Savannah
Hawaii
Kapiolani Medical Center for Women and Children
Recruiting
Honolulu
Iowa
Blank Children's Hospital
Recruiting
Des Moines
University of Iowa/Holden Comprehensive Cancer Center
Recruiting
Iowa City
Idaho
Saint Luke's Cancer Institute - Boise
Recruiting
Boise
Illinois
Lurie Children's Hospital-Chicago
Recruiting
Chicago
University of Illinois
Recruiting
Chicago
Loyola University Medical Center
Recruiting
Maywood
Advocate Children's Hospital-Oak Lawn
Recruiting
Oak Lawn
Advocate Children's Hospital-Park Ridge
Recruiting
Park Ridge
Saint Jude Midwest Affiliate
Recruiting
Peoria
Southern Illinois University School of Medicine
Recruiting
Springfield
Indiana
Riley Hospital for Children
Recruiting
Indianapolis
Saint Vincent Hospital and Health Care Center
Recruiting
Indianapolis
Kentucky
University of Kentucky/Markey Cancer Center
Recruiting
Lexington
Norton Children's Hospital
Recruiting
Louisville
Louisiana
Children's Hospital New Orleans
Recruiting
New Orleans
Ochsner Medical Center Jefferson
Recruiting
New Orleans
Massachusetts
Dana-Farber Cancer Institute
Recruiting
Boston
Massachusetts General Hospital Cancer Center
Recruiting
Boston
Tufts Children's Hospital
Recruiting
Boston
UMass Memorial Medical Center - University Campus
Recruiting
Worcester
Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
Recruiting
Baltimore
Sinai Hospital of Baltimore
Recruiting
Baltimore
University of Maryland/Greenebaum Cancer Center
Recruiting
Baltimore
Walter Reed National Military Medical Center
Recruiting
Bethesda
Maine
Maine Children's Cancer Program
Recruiting
Scarborough
Michigan
C S Mott Children's Hospital
Recruiting
Ann Arbor
Ascension Saint John Hospital
Recruiting
Detroit
Michigan State University Clinical Center
Recruiting
East Lansing
Helen DeVos Children's Hospital at Spectrum Health
Recruiting
Grand Rapids
Bronson Methodist Hospital
Recruiting
Kalamazoo
Beaumont Children's Hospital-Royal Oak
Recruiting
Royal Oak
Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis
Recruiting
Minneapolis
University of Minnesota/Masonic Cancer Center
Recruiting
Minneapolis
Mayo Clinic in Rochester
Recruiting
Rochester
Missouri
Columbia Regional
Recruiting
Columbia
Children's Mercy Hospitals and Clinics
Recruiting
Kansas City
Cardinal Glennon Children's Medical Center
Recruiting
Saint Louis
Mercy Hospital Saint Louis
Recruiting
Saint Louis
Washington University School of Medicine
Recruiting
Saint Louis
Mississippi
University of Mississippi Medical Center
Recruiting
Jackson
North Carolina
Mission Hospital
Recruiting
Asheville
UNC Lineberger Comprehensive Cancer Center
Recruiting
Chapel Hill
Carolinas Medical Center/Levine Cancer Institute
Recruiting
Charlotte
Novant Health Presbyterian Medical Center
Recruiting
Charlotte
Duke University Medical Center
Recruiting
Durham
East Carolina University
Recruiting
Greenville
Wake Forest University Health Sciences
Recruiting
Winston-salem
North Dakota
Sanford Broadway Medical Center
Recruiting
Fargo
Nebraska
Children's Hospital and Medical Center of Omaha
Recruiting
Omaha
University of Nebraska Medical Center
Recruiting
Omaha
New Hampshire
Dartmouth Hitchcock Medical Center
Recruiting
Lebanon
New Jersey
Hackensack University Medical Center
Recruiting
Hackensack
Morristown Medical Center
Recruiting
Morristown
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
Recruiting
New Brunswick
Saint Peter's University Hospital
Recruiting
New Brunswick
Newark Beth Israel Medical Center
Recruiting
Newark
Saint Joseph's Regional Medical Center
Recruiting
Paterson
Nevada
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Recruiting
Las Vegas
Summerlin Hospital Medical Center
Recruiting
Las Vegas
Sunrise Hospital and Medical Center
Recruiting
Las Vegas
University Medical Center of Southern Nevada
Recruiting
Las Vegas
Renown Regional Medical Center
Recruiting
Reno
New York
Albany Medical Center
Recruiting
Albany
Montefiore Medical Center - Moses Campus
Recruiting
Bronx
Maimonides Medical Center
Recruiting
Brooklyn
Roswell Park Cancer Institute
Recruiting
Buffalo
NYU Winthrop Hospital
Recruiting
Mineola
The Steven and Alexandra Cohen Children's Medical Center of New York
Recruiting
New Hyde Park
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Recruiting
New York
Memorial Sloan Kettering Cancer Center
Recruiting
New York
Mount Sinai Hospital
Recruiting
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Recruiting
New York
NYP/Weill Cornell Medical Center
Recruiting
New York
University of Rochester
Recruiting
Rochester
Stony Brook University Medical Center
Recruiting
Stony Brook
State University of New York Upstate Medical University
Recruiting
Syracuse
New York Medical College
Recruiting
Valhalla
Ohio
Children's Hospital Medical Center of Akron
Recruiting
Akron
Cincinnati Children's Hospital Medical Center
Recruiting
Cincinnati
Cleveland Clinic Foundation
Recruiting
Cleveland
Rainbow Babies and Childrens Hospital
Recruiting
Cleveland
Nationwide Children's Hospital
Recruiting
Columbus
Dayton Children's Hospital
Recruiting
Dayton
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Recruiting
Toledo
Oklahoma
University of Oklahoma Health Sciences Center
Recruiting
Oklahoma City
Oregon
Legacy Emanuel Children's Hospital
Recruiting
Portland
Oregon Health and Science University
Recruiting
Portland
Pennsylvania
Lehigh Valley Hospital-Cedar Crest
Recruiting
Allentown
Geisinger Medical Center
Recruiting
Danville
Penn State Children's Hospital
Recruiting
Hershey
Children's Hospital of Philadelphia
Recruiting
Philadelphia
Saint Christopher's Hospital for Children
Recruiting
Philadelphia
Children's Hospital of Pittsburgh of UPMC
Recruiting
Pittsburgh
Rhode Island
Rhode Island Hospital
Recruiting
Providence
South Carolina
Medical University of South Carolina
Recruiting
Charleston
Prisma Health Richland Hospital
Recruiting
Columbia
BI-LO Charities Children's Cancer Center
Recruiting
Greenville
South Dakota
Sanford USD Medical Center - Sioux Falls
Recruiting
Sioux Falls
Tennessee
T C Thompson Children's Hospital
Recruiting
Chattanooga
East Tennessee Childrens Hospital
Recruiting
Knoxville
The Children's Hospital at TriStar Centennial
Recruiting
Nashville
Vanderbilt University/Ingram Cancer Center
Recruiting
Nashville
Texas
Dell Children's Medical Center of Central Texas
Recruiting
Austin
Driscoll Children's Hospital
Recruiting
Corpus Christi
Medical City Dallas Hospital
Recruiting
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Recruiting
Dallas
El Paso Children's Hospital
Recruiting
El Paso
Cook Children's Medical Center
Recruiting
Fort Worth
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Recruiting
Houston
M D Anderson Cancer Center
Recruiting
Houston
Children's Hospital of San Antonio
Recruiting
San Antonio
Methodist Children's Hospital of South Texas
Recruiting
San Antonio
University of Texas Health Science Center at San Antonio
Recruiting
San Antonio
Scott and White Memorial Hospital
Recruiting
Temple
Utah
Primary Children's Hospital
Recruiting
Salt Lake City
Virginia
Inova Fairfax Hospital
Recruiting
Falls Church
Children's Hospital of The King's Daughters
Recruiting
Norfolk
Naval Medical Center - Portsmouth
Recruiting
Portsmouth
Virginia Commonwealth University/Massey Cancer Center
Recruiting
Richmond
Carilion Children's
Recruiting
Roanoke
Vermont
University of Vermont and State Agricultural College
Recruiting
Burlington
Washington
Seattle Children's Hospital
Recruiting
Seattle
Providence Sacred Heart Medical Center and Children's Hospital
Recruiting
Spokane
Madigan Army Medical Center
Recruiting
Tacoma
Mary Bridge Children's Hospital and Health Center
Recruiting
Tacoma
Wisconsin
Saint Vincent Hospital Cancer Center Green Bay
Recruiting
Green Bay
University of Wisconsin Carbone Cancer Center
Recruiting
Madison
Marshfield Medical Center-Marshfield
Recruiting
Marshfield
Children's Hospital of Wisconsin
Recruiting
Milwaukee
West Virginia
West Virginia University Charleston Division
Recruiting
Charleston
Other Locations
Canada
University of Alberta Hospital
Recruiting
Edmonton
IWK Health Centre
Recruiting
Halifax
McMaster Children's Hospital at Hamilton Health Sciences
Recruiting
Hamilton
Children's Hospital
Recruiting
London
Centre Hospitalier Universitaire Sainte-Justine
Recruiting
Montreal
The Montreal Children's Hospital of the MUHC
Recruiting
Montreal
Children's Hospital of Eastern Ontario
Recruiting
Ottawa
Centre Hospitalier Universitaire de Quebec
Recruiting
Quebec
Hospital for Sick Children
Recruiting
Toronto
CancerCare Manitoba
Recruiting
Winnipeg
Puerto Rico
University Pediatric Hospital
Recruiting
San Juan
Time Frame
Start Date: July 20, 2020
Estimated Completion Date: September 30, 2027
Participants
Target number of participants: 1400
Treatments
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.
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.
Experimental: Arm B Low Risk Group 1
Arm B Low Risk Group 1: See Detailed Description.
Experimental: Arm B Low Risk Group 2
Arm B Low Risk Group 2: See Detailed Description.
Experimental: Arm BC High Risk Group
Arm BC High Risk Group: See Detailed Description.
Experimental: Arm BC Low Risk Group 2
Arm BC Low Risk Group 2: See Detailed Description.
Experimental: Arm BD High Risk Group
Arm BD High Risk Group: See Detailed Description.
Experimental: Arm BD Low Risk Group 2
Arm BD Low Risk Group 2: See Detailed Description.
Authors
Craig Erker, Lisa L. Hartman, David J. Slomiany, Angela R. Girvin, Hamayun Imran, Elyssa M. Rubin, Robin Y. Dulman, Haydar A. Frangoul, Michael J. Burke, Nina S. Kadan-Lottick, Alissa Kahn, Eric C. Larsen, Kathryn L. Laurie, Marcio H. Malogolowkin, Jessica C. Hochberg, Anna B. Pawlowska, Mary L. Schmidt, Vinod K. Gidvani-Diaz, Julio C. Barredo, Matthew A. Kutny, Eric J. Lowe, William A. May, Gary D. Crouch, Mariko Sato, Peter M. Gordon, Jenna Rossoff, Ashok B. Raj, Jessica Boklan, Keith J. August, Chana L. Glasser, Lisa Gennarini, Stanton C. Goldman, Neerav N. Shukla, Michael S. Isakoff, Justine M. Kahn, Kayelyn J. Wagner, Mukund G. Dole, David L. Becton, Laura E. Agresta, Adit L. Tal, Lars M. Wagner, Phillip E. Barnette, Rabi Hanna, Timothy C. Griffin, Robin D. Hanson, Shilpa A. Shahani, Jordyn R. Griffin, Juan F. Rico, Erwood G. Edwards, Ranjan Bista, Jennifer A. Domm, Don E. Eslin, William B. Slayton, Lolie C. Yu, Iftikhar Hanif, Holly E. Pariury, Catherine A. Long, Mark A. Ranalli, David S. Dickens, Pooja Hingorani, Leo Mascarenhas, Laura E. Hogan, Jamie L. Dargart, Shalini Shenoy, Nibal A. Zaghloul, Adonis N. Lorenzana, Jason Law, Kenneth M. Heym, Duncan S. Stearns, Himalee S. Sabnis, Andrew L. Pendleton, Barbara A. Gruner, Craig A. Mullen, Jose M. Esquilin, Aarati V. Rao, Joseph C. Torkildson, Michelle A. Manalang, Clare J. Twist, Craig Lotterman, Erlyn C. Smith, Aniket Saha, Maria E. Echevarria, Colleen H. McDonough, Eugenia Chang, Lauren Pommert, Sandeep Batra, Benjamin J. Huang, Aghiad Chamdin, Arlene S. Redner, Alexander J. Chou, Meghann P. McManus, Richard A. Drachtman, Nicholas W. McGregor, James T. Badgett, Robert G. Irwin, Carla B. Golden, Susan E. Spiller, Mallorie B. Heneghan, Douglas J. Scothorn, Eugene Suh, Jennifer M. Levine, Fouad M. Hajjar, Judy L. Felgenhauer, Jacob A. Troutman, Mira Kohorst, Minnie Abromowitch, Kelly W. Maloney, Wade T. Kyono, Amy A. Smith, Emi H. Caywood, William D. Roberts, Laura Sedig, Bethany M. Mikles, Mahmut Y. Celiker, Gregory P. Brandt, William S. Ferguson, Marshall A. Schorin, Alan D. Friedman, Lisa M. McGregor, Robert M. Cooper, Nichole L. Bryant, Laura A. Campbell, Jennifer J. Welch, Jagadeesh Ramdas, Philip M. Monteleone, Stuart L. Cramer, Andrea R. Whitfield, Jeffrey A. Toretsky, Joel A. Kaplan, Jean M. Tersak, Gregory E. Halligan, Bassem I. Razzouk, Tamra L. Slone, Steven P. Margossian, Samuel J. Milanovich, Alan K. Ikeda, Samantha L. Mallory, Enrique A. Escalon, Nkechi I. Mba, Jessica A. Pollard, John T. Horan, Janice F. Olson, Laura K. Gowans, Rebecca E. McFall, Narayana Gowda, Howard J. Weinstein, Michael K. Richards, Steven J. Kuerbitz, Alice Lee, Lauren R. Weintraub, Mark E. Weinblatt, Jason M. Fixler, Sharon L. Gardner, Jill C. Beck, Todd M Cooper, Jennifer J. Clark, Julie Kim, Richard Aplenc, Jessica A. Bell, Teena Bhatla, Teresa A. York, Jessica L. Heath, Albert Kheradpour, Jeffrey S. Dome, Melissa A. Forouhar, Mohamad H. Badawi, Pillai Pallavi Madhusoodhan, Maureen M. O'Brien, Stefanie R. Lowas, Melissa S. Singer, Farzana Pashankar, John J. Gregory, Dana B. Salzberg, Emad K. Salman, Stuart H. Gold, Kenneth B. De Santes, Felipe S. Bautista-Otanez, Jing Chen, Rebecca O. Clark, Jennifer L. Mayer, Jacqueline N. Casillas, Ashley Chopek, Sharon B. Abish, Ayman A. El-Sheikh, Yvan Samson, Anne-Marie R. Langevin, Donna L. Johnston, Shannon M. Cohn, Najat C. Daw, Uma H. Athale, Jacqueline M. Kraveka, Johann Hitzler, Fataneh (Fae) Majlessipour, Jennifer J. Greene Welch, Shayna M. Zelcer, Rene Y. McNall-Knapp, Sara Zarnegar-Lumley, David E. Kram, Kathleen J. Yost, Jaime M. Libes, Hector M. Rodriguez-Cortes, Bill H. Chang, Sarah J. McKillop, Sarah E. Leary, Anderson (Andy) B. Collier, Alexandra M. Stevens, Bruno Michon, Kenneth Lieuw
Sponsors
Leads: Children's Oncology Group
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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