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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

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

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04726241
Enrollment
960
Registered
2021-01-27
Start date
2022-04-18
Completion date
2030-12-31
Last updated
2026-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Brief summary

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.

Detailed description

PRIMARY OBJECTIVES: I. To utilize clinical and biological characteristics of acute leukemias to screen for patient eligibility for available phase I/II Pediatric Acute Leukemia (PedAL) sub-trials. II. To maintain a longitudinal and comprehensive registry, as well as a specimen bank, from relapse in children and young adults with acute leukemias. OUTLINE: Patients undergo collection of blood and/or bone marrow samples at baseline, end of treatment cycle(s), and at relapse/refractory disease status (if applicable). After completion of study, patients are followed up every 3 months for 2 years, and then every 6 months for 3 years.

Interventions

PROCEDUREBiospecimen Collection

Undergo collection of blood and/or bone marrow samples

Sponsors

PedAL BCU, LLC
Lead SponsorOTHER
Children's Oncology Group
CollaboratorNETWORK
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 22 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients with identification of a priori specified genomic and immunophenotypic targets who enroll on a sub-trialUp to 5 yearsThe 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 yearsThe number of patients with at least one specimen submitted to the bank will be reported.

Countries

Australia, Canada, New Zealand, Puerto Rico, United States

Contacts

PRINCIPAL_INVESTIGATORMichele S Redell

Children's Oncology Group

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 26, 2026