Children's National

Conditions

• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia
• Acute Myeloid Leukemia Post Cytotoxic Therapy
• Juvenile Myelomonocytic Leukemia
• Mixed Phenotype Acute Leukemia
• Myelodysplastic Syndrome
• Myelodysplastic Syndrome Post Cytotoxic Therapy
• Myeloid Leukemia Associated With Down Syndrome

Eligibility

Eligible Ages

Under 22 Years

Eligible Genders

All

Accepts Healthy Volunteers

No

Criteria

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

Detailed 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, 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.