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Screening for pediatric leukemia in children with relapsed or difficult-to-treat cases

Pediatric Acute Leukemia (PedAL) Screening Trial - Developing New Therapies for Relapsed Leukemias

Phase1; Phase2 Interventional PedAL BCU, LLC · NCT04726241

This study is testing how to better screen children and young adults with tough cases of leukemia to see if they qualify for new treatment options.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment960 (estimated)
AgesN/A to 22 Years
SexAll
SponsorPedAL BCU, LLC Academic / other
Locations183 sites (Birmingham, Alabama and 182 other locations)
Trial IDNCT04726241 on ClinicalTrials.gov

What this trial studies

This study aims to screen children and young adults with relapsed or refractory acute leukemias by analyzing their clinical and biological characteristics. It involves collecting blood and bone marrow samples to determine eligibility for various pediatric leukemia sub-trials. The study also maintains a comprehensive registry and specimen bank to support ongoing research and treatment strategies. Patients will be monitored for several years after their participation to assess long-term outcomes.

Who should consider this trial

Good fit: Ideal candidates are children and young adults under 22 years old with relapsed or refractory acute leukemias.

Not a fit: Patients with leukemia that is not relapsed or refractory may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic and treatment options for children with difficult-to-treat leukemia.

How similar studies have performed: Other studies have shown promise in utilizing biological characteristics for patient stratification in leukemia, indicating a potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Birmingham, Alabama and 182 other locations

+133 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaAcute Myeloid Leukemia Post Cytotoxic TherapyJuvenile Myelomonocytic LeukemiaMixed Phenotype Acute LeukemiaMyelodysplastic SyndromeMyelodysplastic Syndrome Post Cytotoxic TherapyMyeloid Leukemia Associated With Down Syndrome
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.