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

Study Overview
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Brief Summary
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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
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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 from relapse in children and young adults with recurrent and refractory leukemia. 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.

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

Conditions
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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

Intervention / Treatment
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* Procedure: Biospecimen Collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be less than 22 years of age at the time of study enrollment Patient must have one of the following: Patient has known or suspected relapsed/refractory (including primary refractory) AML This includes isolated myeloid sarcoma Patient has known or suspected relapsed/refractory (including primary refractory) myeloid leukemia of Down syndrome Patient has known or suspected relapsed ALL 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) Patient has known or suspected de novo or relapsed/refractory (including primary refractory) treatment-related AML (t-AML) or treatment-related myelodysplastic syndrome (t-MDS) Patient has known or suspected de novo or relapsed/refractory (including primary refractory) myelodysplastic syndrome (MDS) Patient has known or suspected de novo or relapsed/refractory (including primary refractory) juvenile myelomonocytic leukemia (JMML) 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

Ages Eligible for Study
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Maximum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Screening (biospecimen collection)<br>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). | Procedure: Biospecimen Collection<br>* Undergo collection of blood and/or bone marrow samples<br>* Other names: Specimen Collection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 5 years |