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
Launched by LLS PEDAL INITIATIVE, LLC · Jan 22, 2021
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The Pediatric Acute Leukemia (PedAL) Screening Trial is a study designed to help doctors understand and treat different types of leukemia in children and young adults, especially when the leukemia comes back after treatment or is hard to treat. Researchers will collect samples of bone marrow and blood from eligible patients to look for important information about their leukemia. This information can guide doctors in choosing the best treatment options and could lead to better ways to diagnose and manage leukemia in the future.
To participate in this trial, patients need to be under 22 years old and have specific types of leukemia that are relapsed or difficult to treat, such as Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML). If you or someone you know is considering joining this study, you will need to provide consent, and there are guidelines that must be followed to ensure safety and ethical standards are met. Participants can expect to have their blood and bone marrow tested, which will help researchers gather valuable information to improve leukemia treatments for kids and young adults.
Gender
ALL
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
About Lls Pedal Initiative, Llc
LLS Pedal Initiative, LLC is a dedicated clinical trial sponsor focused on advancing innovative therapies and treatments for individuals affected by blood cancers. Committed to enhancing patient outcomes, the organization collaborates with leading research institutions and healthcare professionals to design and implement rigorous clinical studies that prioritize safety and efficacy. Through its initiatives, LLS Pedal Initiative aims to foster groundbreaking research and facilitate the development of novel interventions, ultimately striving to improve the quality of life for patients and their families in the fight against blood disorders.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New Haven, Connecticut, United States
Lebanon, New Hampshire, United States
Brooklyn, New York, United States
Durham, North Carolina, United States
Charleston, South Carolina, United States
Cleveland, Ohio, United States
Philadelphia, Pennsylvania, United States
Saint Louis, Missouri, United States
Detroit, Michigan, United States
Providence, Rhode Island, United States
Dallas, Texas, United States
Ottawa, Ontario, Canada
Kalamazoo, Michigan, United States
Maywood, Illinois, United States
Loma Linda, California, United States
Valhalla, New York, United States
Winnipeg, Manitoba, Canada
Anchorage, Alaska, United States
Hackensack, New Jersey, United States
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Peoria, Illinois, United States
Oklahoma City, Oklahoma, United States
Parkville, Victoria, Australia
Toronto, Ontario, Canada
Orange, California, United States
Scarborough, Maine, United States
Akron, Ohio, United States
Lubbock, Texas, United States
Norfolk, Virginia, United States
New York, New York, United States
Baltimore, Maryland, United States
Little Rock, Arkansas, United States
Des Moines, Iowa, United States
Halifax, Nova Scotia, Canada
Jackson, Mississippi, United States
Minneapolis, Minnesota, United States
New Brunswick, New Jersey, United States
Austin, Texas, United States
Corpus Christi, Texas, United States
Calgary, Alberta, Canada
Quebec, , Canada
Hershey, Pennsylvania, United States
Charlottesville, Virginia, United States
Houston, Texas, United States
Tacoma, Washington, United States
San Antonio, Texas, United States
Springfield, Illinois, United States
Cincinnati, Ohio, United States
San Antonio, Texas, United States
Boston, Massachusetts, United States
Los Angeles, California, United States
Rochester, New York, United States
Danville, Pennsylvania, United States
Tucson, Arizona, United States
Washington, District Of Columbia, United States
Savannah, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Iowa City, Iowa, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Bethesda, Maryland, United States
Minneapolis, Minnesota, United States
Omaha, Nebraska, United States
New York, New York, United States
New York, New York, United States
Syracuse, New York, United States
Chapel Hill, North Carolina, United States
Winston Salem, North Carolina, United States
Fargo, North Dakota, United States
Nashville, Tennessee, United States
Birmingham, Alabama, United States
Hartford, Connecticut, United States
Lexington, Kentucky, United States
Charlotte, North Carolina, United States
Allentown, Pennsylvania, United States
Morgantown, West Virginia, United States
Falls Church, Virginia, United States
Washington, District Of Columbia, United States
Honolulu, Hawaii, United States
Portland, Oregon, United States
Grand Rapids, Michigan, United States
Portland, Oregon, United States
Cleveland, Ohio, United States
Phoenix, Arizona, United States
Oakland, California, United States
San Diego, California, United States
Aurora, Colorado, United States
Wilmington, Delaware, United States
Fort Lauderdale, Florida, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Chicago, Illinois, United States
New Orleans, Louisiana, United States
Ann Arbor, Michigan, United States
East Lansing, Michigan, United States
Saint Louis, Missouri, United States
New Brunswick, New Jersey, United States
Paterson, New Jersey, United States
Albany, New York, United States
New Hyde Park, New York, United States
Stony Brook, New York, United States
Charlotte, North Carolina, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Sioux Falls, South Dakota, United States
Knoxville, Tennessee, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Montreal, Quebec, Canada
Grafton, Auckland, New Zealand
Christchurch, , New Zealand
Downey, California, United States
Long Beach, California, United States
Madera, California, United States
Oakland, California, United States
Palo Alto, California, United States
San Francisco, California, United States
Denver, Colorado, United States
Fort Myers, Florida, United States
Gainesville, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Saint Petersburg, Florida, United States
Atlanta, Georgia, United States
Indianapolis, Indiana, United States
Louisville, Kentucky, United States
Rochester, Minnesota, United States
Columbia, Missouri, United States
Kansas City, Missouri, United States
Saint Louis, Missouri, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Morristown, New Jersey, United States
Bronx, New York, United States
Mineola, New York, United States
Asheville, North Carolina, United States
Toledo, Ohio, United States
Columbia, South Carolina, United States
Greenville, South Carolina, United States
Memphis, Tennessee, United States
Roanoke, Virginia, United States
Madison, Wisconsin, United States
Marshfield, Wisconsin, United States
Westmead, New South Wales, Australia
South Brisbane, Queensland, Australia
London, Ontario, Canada
Montreal, Quebec, Canada
Reno, Nevada, United States
Greenville, North Carolina, United States
Albuquerque, New Mexico, United States
Mobile, Alabama, United States
Mesa, Arizona, United States
Pensacola, Florida, United States
Boise, Idaho, United States
Royal Oak, Michigan, United States
Sherbrooke, Quebec, Canada
Park Ridge, Illinois, United States
Las Vegas, Nevada, United States
San Antonio, Texas, United States
Perth, Western Australia, Australia
Nashville, Tennessee, United States
Lubbock, Texas, United States
El Paso, Texas, United States
Caguas, , Puerto Rico
Columbia, Missouri, United States
Saint Louis, Missouri, United States
East Lansing, Michigan, United States
Mineola, New York, United States
Indianapolis, Indiana, United States
Lebanon, New Hampshire, United States
West Palm Beach, Florida, United States
Quebec, , Canada
Madison, Wisconsin, United States
Grand Rapids, Michigan, United States
Royal Oak, Michigan, United States
Atlanta, Georgia, United States
Patients applied
Trial Officials
Michele S Redell
Principal Investigator
Children's Oncology Group
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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