PHO-COG-APAL2020SC

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.

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
* Patient has known or suspected de novo or relapsed/refractory (including primary refractory) treatment related AML
* 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

Leukemia, not otherwise specified
Leukemia, other

IU Health North Hospital

• IU Health North Hospital

• Riley Hospital for Children