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

Recruiting now · Phase 1/Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT04726241

Run by

PedAL BCU, LLC

People needed

960

Starts

2022-04-18

Expected to finish

2030-12-31

Last updated by the study team

2026-06-18

Who can join

Age: any, up to 22. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Children's Hospital of Alabama — Birmingham, Alabama, United States (enrolling)
• Broward Health Medical Center — Fort Lauderdale, Florida, United States (enrolling)
• USA Health Strada Patient Care Center — Mobile, Alabama, United States (enrolling)
• Phoenix Childrens Hospital — Phoenix, Arizona, United States (enrolling)
• Providence Alaska Medical Center — Anchorage, Alaska, United States (enrolling)
• Arkansas Children's Hospital — Little Rock, Arkansas, United States (enrolling)
• Banner Children's at Desert — Mesa, Arizona, United States (enrolling)
• Loma Linda University Medical Center — Loma Linda, California, United States (enrolling)
• Miller Children's and Women's Hospital Long Beach — Long Beach, California, United States (enrolling)
• Children's Hospital Los Angeles — Los Angeles, California, United States (enrolling)
• Banner University Medical Center - Tucson — Tucson, Arizona, United States (enrolling)
• UCSF Benioff Children's Hospital Oakland — Oakland, California, United States (enrolling)
• Kaiser Permanente-Oakland — Oakland, California, United States (enrolling)
• Children's Hospital of Orange County — Orange, California, United States (enrolling)
• Lucile Packard Children's Hospital Stanford University — Palo Alto, California, United States (enrolling)
• Kaiser Permanente Downey Medical Center — Downey, California, United States (enrolling)
• UCSF Medical Center-Mission Bay — San Francisco, California, United States (enrolling)
• Children's Hospital Colorado — Aurora, Colorado, United States (enrolling)
• Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center — Denver, Colorado, United States (enrolling)
• Connecticut Children's Medical Center — Hartford, Connecticut, United States (enrolling)
• Yale University — New Haven, Connecticut, United States (enrolling)
• Alfred I duPont Hospital for Children — Wilmington, Delaware, United States (enrolling)
• Valley Children's Hospital — Madera, California, United States (enrolling)
• Children's National Medical Center — Washington D.C., District of Columbia, United States (enrolling)
• Golisano Children's Hospital of Southwest Florida — Fort Myers, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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