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

PedAL BCU, LLC

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Myeloid Leukemia Associated With Down Syndrome; Mixed Phenotype Acute Leukemia; Juvenile Myelomonocytic Leukemia; Acute Lymphoblastic Leukemia; Myelodysplastic Syndrome; Acute Myeloid Leukemia; Myelodysplastic Syndrome Post Cytotoxic Therapy; Acute Myeloid Leukemia Post Cytotoxic Therapy

Treatments: Procedure: Biospecimen Collection

Study type: Interventional

Funder types: Other; NETWORK; NIH

Identifiers

NCT04726241

NCI-2021-00056 (Registry Identifier)

U10CA180886 (U.S. NIH Grant/Contract)

APAL2020SC (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 960 estimated patients

Sex: All

Ages: Under 22 years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

960 participants in 1 patient group

Screening (biospecimen collection)

Experimental group

Description:

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).

Treatment:

Procedure: Biospecimen Collection