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

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.

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