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The Pediatric Acute Leukemia (PedAL) Screening Trial - A Study to Test Bone Marrow and Blood in Children With Leukemia That Has Come Back After Treatment or Is Difficult to Treat - A Leukemia & Lymphoma Society and Children's Oncology Group Study

Sponsor: PedAL BCU, LLC • ClinicalTrials.gov ID: NCT04726241

Registry updated: 2026-08-25
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Description

This study aims to use clinical and biological characteristics of acute leukemias to screen for patient eligibility for available pediatric leukemia sub-trials. Testing bone marrow and blood from patients with leukemia that has come back after treatment or is difficult to treat may provide information about the patient's leukemia that is important when deciding how to best treat it, and may help doctors find better ways to diagnose and treat leukemia in children, adolescents, and young adults.

Interventions

  • Biospecimen Collection (Procedure)
    Undergo collection of blood and/or bone marrow samples

Eligibility criteria

Inclusion Criteria: * Patients must be less than 22 years of age at the time of study enrollment * Patient must have one of the following at the time of study enrollment: * Patient has known or suspected relapsed/refractory (including primary refractory) AML as defined in protocol * This includes isolated myeloid sarcoma * Patient has known or suspected relapsed/refractory (including primary refractory) myeloid leukemia of Down syndrome (ML-DS) * Patient has known or suspected relapsed ALL as defined in protocol that meets one of the following criteria: * Second or greater B-ALL medullary relapse, excluding KMT2Ar * Any first or greater B-ALL medullary relapse involving KMT2Ar * Any first or greater T-ALL medullary relapse with or without KMT2Ar * Patient has known or suspected relapsed/refractory (including primary refractory) mixed phenotype acute leukemia (MPAL) as defined in protocol * Patient has known or suspected de novo or relapsed/refractory (including primary refractory) treatment-related AML (t-AML) * Patient has known or suspected de novo or relapsed/refractory (including primary refractory) myelodysplastic syndrome (MDS) or treatment-related myelodysplastic syndrome (t-MDS) * Note: Relapsed/refractory disease includes stable disease, progressive disease, and disease relapse. * Patient has known or suspected de novo or relapsed/refractory (including primary refractory) juvenile myelomonocytic leukemia (JMML) * Note: Relapsed/refractory disease includes stable disease, progressive disease, and disease relapse. * All patients and/or their parents or legal guardians must sign a written informed consent * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Conditions

Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Acute Myeloid Leukemia Post Cytotoxic Therapy Juvenile Myelomonocytic Leukemia Mixed Phenotype Acute Leukemia Myelodysplastic Syndrome Myelodysplastic Syndrome Post Cytotoxic Therapy Myeloid Leukemia Associated With Down Syndrome

Locations

  • Children's Hospital of Alabama — Birmingham, Alabama, United States
  • USA Health Strada Patient Care Center — Mobile, Alabama, United States
  • Providence Alaska Medical Center — Anchorage, Alaska, United States
  • Banner Children's at Desert — Mesa, Arizona, United States
  • Phoenix Childrens Hospital — Phoenix, Arizona, United States
  • Banner University Medical Center - Tucson — Tucson, Arizona, United States
  • Arkansas Children's Hospital — Little Rock, Arkansas, United States
  • Kaiser Permanente Downey Medical Center — Downey, California, United States
  • Loma Linda University Medical Center — Loma Linda, California, United States
  • Miller Children's and Women's Hospital Long Beach — Long Beach, California, United States
  • Children's Hospital Los Angeles — Los Angeles, California, United States
  • Valley Children's Hospital — Madera, California, United States
  • UCSF Benioff Children's Hospital Oakland — Oakland, California, United States
  • Kaiser Permanente-Oakland — Oakland, California, United States
  • Children's Hospital of Orange County — Orange, California, United States
  • Lucile Packard Children's Hospital Stanford University — Palo Alto, California, United States
  • Rady Children's Hospital - San Diego — San Diego, California, United States
  • UCSF Medical Center-Mission Bay — San Francisco, California, United States
  • Children's Hospital Colorado — Aurora, Colorado, United States
  • Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center — Denver, Colorado, United States
  • Connecticut Children's Medical Center — Hartford, Connecticut, United States
  • Yale University — New Haven, Connecticut, United States
  • Alfred I duPont Hospital for Children — Wilmington, Delaware, United States
  • MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
  • Children's National Medical Center — Washington D.C., District of Columbia, United States
  • Broward Health Medical Center — Fort Lauderdale, Florida, United States
  • Golisano Children's Hospital of Southwest Florida — Fort Myers, Florida, United States
  • UF Health Cancer Institute - Gainesville — Gainesville, Florida, United States
  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital — Hollywood, Florida, United States
  • Nemours Children's Clinic-Jacksonville — Jacksonville, Florida, United States
  • Nicklaus Children's Hospital — Miami, Florida, United States
  • Arnold Palmer Hospital for Children — Orlando, Florida, United States
  • Nemours Children's Hospital — Orlando, Florida, United States
  • Nemours Children's Clinic - Pensacola — Pensacola, Florida, United States
  • Sacred Heart Hospital — Pensacola, Florida, United States
  • Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States
  • Saint Joseph's Hospital/Children's Hospital-Tampa — Tampa, Florida, United States
  • Saint Mary's Medical Center — West Palm Beach, Florida, United States
  • Children's Healthcare of Atlanta - Arthur M Blank Hospital — Atlanta, Georgia, United States
  • Memorial Health University Medical Center — Savannah, Georgia, United States
  • Kapiolani Medical Center for Women and Children — Honolulu, Hawaii, United States
  • Saint Luke's Cancer Institute - Boise — Boise, Idaho, United States
  • Lurie Children's Hospital-Chicago — Chicago, Illinois, United States
  • University of Illinois — Chicago, Illinois, United States
  • University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
  • Loyola University Medical Center — Maywood, Illinois, United States
  • Advocate Children's Hospital-Oak Lawn — Oak Lawn, Illinois, United States
  • Advocate Children's Hospital-Park Ridge — Park Ridge, Illinois, United States
  • OSF Children's Hospital of Illinois — Peoria, Illinois, United States
  • Southern Illinois University School of Medicine — Springfield, Illinois, United States
  • Northwestern Medicine Central DuPage Hospital — Winfield, Illinois, United States
  • Riley Hospital for Children — Indianapolis, Indiana, United States
  • Ascension Saint Vincent Indianapolis Hospital — Indianapolis, Indiana, United States
  • Blank Children's Hospital — Des Moines, Iowa, United States
  • University of Iowa/Holden Comprehensive Cancer Center — Iowa City, Iowa, United States
  • University of Kentucky/Markey Cancer Center — Lexington, Kentucky, United States
  • Norton Children's Hospital — Louisville, Kentucky, United States
  • Children's Hospital New Orleans — New Orleans, Louisiana, United States
  • Ochsner Medical Center Jefferson — New Orleans, Louisiana, United States
  • Eastern Maine Medical Center — Bangor, Maine, United States
  • Maine Children's Cancer Program — Scarborough, Maine, United States
  • Sinai Hospital of Baltimore — Baltimore, Maryland, United States
  • Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland, United States
  • Walter Reed National Military Medical Center — Bethesda, Maryland, United States
  • Dana-Farber Cancer Institute — Boston, Massachusetts, United States
  • C S Mott Children's Hospital — Ann Arbor, Michigan, United States
  • Children's Hospital of Michigan — Detroit, Michigan, United States
  • Michigan State University — East Lansing, Michigan, United States
  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital — Grand Rapids, Michigan, United States
  • Bronson Methodist Hospital — Kalamazoo, Michigan, United States
  • Corewell Health Children's — Royal Oak, Michigan, United States
  • Children's Hospitals and Clinics of Minnesota - Minneapolis — Minneapolis, Minnesota, United States
  • University of Minnesota/Masonic Cancer Center — Minneapolis, Minnesota, United States
  • Mayo Clinic in Rochester — Rochester, Minnesota, United States
  • University of Mississippi Medical Center — Jackson, Mississippi, United States
  • University of Missouri Children's Hospital — Columbia, Missouri, United States
  • Children's Mercy Hospitals and Clinics — Kansas City, Missouri, United States
  • Cardinal Glennon Children's Medical Center — St Louis, Missouri, United States
  • Washington University School of Medicine — St Louis, Missouri, United States
  • Mercy Hospital Saint Louis — St Louis, Missouri, United States
  • Children's Hospital and Medical Center of Omaha — Omaha, Nebraska, United States
  • University of Nebraska Medical Center — Omaha, Nebraska, United States
  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation — Las Vegas, Nevada, United States
  • Summerlin Hospital Medical Center — Las Vegas, Nevada, United States
  • Renown Regional Medical Center — Reno, Nevada, United States
  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center — Lebanon, New Hampshire, United States
  • Hackensack University Medical Center — Hackensack, New Jersey, United States
  • Morristown Medical Center — Morristown, New Jersey, United States
  • Jersey Shore Medical Center — Neptune City, New Jersey, United States
  • Saint Peter's University Hospital — New Brunswick, New Jersey, United States
  • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States
  • Saint Joseph's Regional Medical Center — Paterson, New Jersey, United States
  • University of New Mexico Cancer Center — Albuquerque, New Mexico, United States
  • Albany Medical Center — Albany, New York, United States
  • Maimonides Medical Center — Brooklyn, New York, United States
  • NYU Langone Hospital - Long Island — Mineola, New York, United States
  • The Steven and Alexandra Cohen Children's Medical Center of New York — New Hyde Park, New York, United States
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone — New York, New York, United States
  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center — New York, New York, United States
  • Memorial Sloan Kettering Cancer Center — New York, New York, United States
  • University of Rochester — Rochester, New York, United States
  • Stony Brook University Medical Center — Stony Brook, New York, United States
  • State University of New York Upstate Medical University — Syracuse, New York, United States
  • Montefiore Medical Center - Moses Campus — The Bronx, New York, United States
  • New York Medical College — Valhalla, New York, United States
  • Mission Hospital — Asheville, North Carolina, United States
  • UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
  • Carolinas Medical Center/Levine Cancer Institute — Charlotte, North Carolina, United States
  • Novant Health Presbyterian Medical Center — Charlotte, North Carolina, United States
  • Duke University Medical Center — Durham, North Carolina, United States
  • East Carolina University — Greenville, North Carolina, United States
  • Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
  • Sanford Broadway Medical Center — Fargo, North Dakota, United States
  • Children's Hospital Medical Center of Akron — Akron, Ohio, United States
  • Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
  • Rainbow Babies and Childrens Hospital — Cleveland, Ohio, United States
  • Cleveland Clinic Foundation — Cleveland, Ohio, United States
  • Nationwide Children's Hospital — Columbus, Ohio, United States
  • Dayton Children's Hospital — Dayton, Ohio, United States
  • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital — Toledo, Ohio, United States
  • University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
  • Legacy Emanuel Children's Hospital — Portland, Oregon, United States
  • Oregon Health and Science University — Portland, Oregon, United States
  • Lehigh Valley Hospital-Cedar Crest — Allentown, Pennsylvania, United States
  • Geisinger Medical Center — Danville, Pennsylvania, United States
  • Penn State Children's Hospital — Hershey, Pennsylvania, United States
  • Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
  • Saint Christopher's Hospital for Children — Philadelphia, Pennsylvania, United States
  • Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
  • Rhode Island Hospital — Providence, Rhode Island, United States
  • Medical University of South Carolina — Charleston, South Carolina, United States
  • Prisma Health Richland Hospital — Columbia, South Carolina, United States
  • BI-LO Charities Children's Cancer Center — Greenville, South Carolina, United States
  • Sanford USD Medical Center - Sioux Falls — Sioux Falls, South Dakota, United States
  • East Tennessee Childrens Hospital — Knoxville, Tennessee, United States
  • Saint Jude Children's Research Hospital — Memphis, Tennessee, United States
  • The Children's Hospital at TriStar Centennial — Nashville, Tennessee, United States
  • Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee, United States
  • Dell Children's Medical Center of Central Texas — Austin, Texas, United States
  • Driscoll Children's Hospital — Corpus Christi, Texas, United States
  • Medical City Dallas Hospital — Dallas, Texas, United States
  • UT Southwestern/Simmons Cancer Center-Dallas — Dallas, Texas, United States
  • El Paso Children's Hospital — El Paso, Texas, United States
  • Cook Children's Medical Center — Fort Worth, Texas, United States
  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center — Houston, Texas, United States
  • UT MD Anderson Cancer Center — Houston, Texas, United States
  • Covenant Children's Hospital — Lubbock, Texas, United States
  • UMC Cancer Center / UMC Health System — Lubbock, Texas, United States
  • Children's Hospital of San Antonio — San Antonio, Texas, United States
  • Methodist Children's Hospital of South Texas — San Antonio, Texas, United States
  • University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
  • Primary Children's Hospital — Salt Lake City, Utah, United States
  • University of Virginia Cancer Center — Charlottesville, Virginia, United States
  • Inova Fairfax Hospital — Falls Church, Virginia, United States
  • Children's Hospital of The King's Daughters — Norfolk, Virginia, United States
  • VCU Massey Comprehensive Cancer Center — Richmond, Virginia, United States
  • Carilion Children's — Roanoke, Virginia, United States
  • Seattle Children's Hospital — Seattle, Washington, United States
  • Providence Sacred Heart Medical Center and Children's Hospital — Spokane, Washington, United States
  • Mary Bridge Children's Hospital and Health Center — Tacoma, Washington, United States
  • Madigan Army Medical Center — Tacoma, Washington, United States
  • West Virginia University Healthcare — Morgantown, West Virginia, United States
  • University of Wisconsin Carbone Cancer Center - University Hospital — Madison, Wisconsin, United States
  • Marshfield Medical Center-Marshfield — Marshfield, Wisconsin, United States
  • The Children's Hospital at Westmead — Westmead, New South Wales, Australia
  • Queensland Children's Hospital — South Brisbane, Queensland, Australia
  • Royal Children's Hospital — Parkville, Victoria, Australia
  • Perth Children's Hospital — Perth, Western Australia, Australia
  • Alberta Children's Hospital — Calgary, Alberta, Canada
  • University of Alberta Hospital — Edmonton, Alberta, Canada
  • British Columbia Children's Hospital — Vancouver, British Columbia, Canada
  • CancerCare Manitoba — Winnipeg, Manitoba, Canada
  • IWK Health Centre — Halifax, Nova Scotia, Canada
  • Children's Hospital — London, Ontario, Canada
  • Children's Hospital of Eastern Ontario — Ottawa, Ontario, Canada
  • Hospital for Sick Children — Toronto, Ontario, Canada
  • The Montreal Children's Hospital of the MUHC — Montreal, Quebec, Canada
  • Centre Hospitalier Universitaire Sainte-Justine — Montreal, Quebec, Canada
  • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont — Sherbrooke, Quebec, Canada
  • CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) — Québec, Canada
  • Starship Children's Hospital — Grafton, Auckland, New Zealand
  • Christchurch Hospital — Christchurch, New Zealand
  • HIMA San Pablo Oncologic Hospital — Caguas, Puerto Rico
  • University Pediatric Hospital — San Juan, Puerto Rico
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record