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

Overview

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.

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 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.

Eligibility

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