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Pediatric Acute Leukemia (PedAL) Screening Trial

This study, called the PedAL Screening Trial, is for children and young adults up to age 22 who have leukemia that has come back after treatment or is difficult to treat. The main goal is to collect blood and bone marrow samples to learn more about your leukemia. By studying these samples, doctors hope to find specific features (biomarkers) that can help them decide the best way to treat your leukemia. This information may also help doctors find better ways to diagnose and treat leukemia in the future. The study aims to screen patients for other available leukemia studies based on these findings. Success for this study means identifying specific genetic and immune markers in patients and creating a comprehensive registry and sample bank for future research.

Study design
This is an interventional study planning to enroll 960 participants. It is designed to use clinical and biological characteristics of acute leukemias to screen for patient eligibility for other sub-trials.
What's involved
You would provide blood and/or bone marrow samples at the beginning of the study, at the end of treatment cycles, and if your disease returns or doesn't respond to treatment.
Compensation
Not stated in the trial record.
Follow-up
After completing the study, you will have follow-up appointments every 3 months for 2 years, and then every 6 months for an additional 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04726241

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
PHASE1Up to 22InterventionalScreening
PedAL BCU, LLC
~960 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:Biospecimen Collection

At a glance

Recruiting sites
174 of 184 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of patients with identification of a priori specified genomic and immunophenotypic targets who enroll on a sub-trial
Measured over Up to 5 years
+1 more outcome measured

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

Explore related trials

Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaHematologic NeoplasmJuvenile Myelomonocytic LeukemiaMixed Phenotype Acute LeukemiaMyelodysplastic SyndromeMyeloid Leukemia Associated with Down SyndromeKMT2A Gene

Where it's being run

184 sites across 61 states
Florida13
Texas13
New York12
California11
Illinois9
North Carolina7
Ohio7
Michigan6

Study leadership

  • Michele S Redell · PRINCIPAL_INVESTIGATOR · Children's Oncology Group

Who to contact

Site Public Contact
[email protected]
205-638-9285
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

What this trial measures

  • Proportion of patients with identification of a priori specified genomic and immunophenotypic targets who enroll on a sub-trialUp to 5 years

    The proportion will be calculated as the percent of eligible patients who are identified to have an a priori specified genomic or immunophenotypic target and who enroll on at least one of the sub-trials. The corresponding confidence interval will be constructed.

  • Maintain a longitudinal and comprehensive registry, as well as specimen bank of children and young adults with acute leukemiasUp to 5 years

    The number of patients with at least one specimen submitted to the bank will be reported.