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

Description
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.

Objective
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.

Treatment Observational (biospecimen collection)
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
Undergo collection of blood and/or bone marrow samples

Key Eligibility Inclusion Criteria:

Patients must be less than 22 years of age at the time of study enrollment

Patient has known or suspected relapsed/refractory AML

Patient has known or suspected relapsed ALL that meets the following criteria:


Second or greater medullary relapse of B-ALL

Any first or greater B or T-ALL medullary relapse involving KMT2A rearrangement (KMT2Ar)

Any first or greater relapse of T-ALL


Known or suspected relapsed/refractory mixed phenotype acute leukemia

Known or suspected treatment related AML - de novo or relapsed/refractory

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

Applicable Disease Sites
Leukemia

Participating Institutions
Gundersen Health System; UW Health University Hospital