Pediatric Acute Leukemia (PedAL) Screening Trial: Developing New Therapies for Relapsed Leukemias.

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