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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

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.

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

RM

1 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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