Health Trials

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

ConditionsAcute Lymphoblastic LeukemiaAcute Myeloid LeukemiaAcute Myeloid Leukemia Post Cytotoxic TherapyJuvenile Myelomonocytic LeukemiaMixed Phenotype Acute LeukemiaMyelodysplastic SyndromeMyelodysplastic Syndrome Post Cytotoxic TherapyMyeloid Leukemia Associated With Down Syndrome
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
AgeUp to 22
SponsorPedAL BCU, LLC

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must be less than 22 years of age 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)

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of blood and/or bone marrow samples

Treatment groups

960 Participants
are divided into 1 treatment group
Group A: Screening (biospecimen collection)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of patients with identification of a priori specified genomic and immunophenotypic targets who enroll on a sub-trial

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.

Time frame
Up to 5 years
2

Maintain a longitudinal and comprehensive registry, as well as specimen bank of children and young adults with acute leukemias

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

Time frame
Up to 5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

PedAL BCU, LLC

Lead sponsor

Children's Oncology Group

Collaborator

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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