Overview
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.
Principal investigator
Eligibility criteria
Inclusion Criteria:
- Patients must be less than 22 years of age at the time of study enrollment
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Patient must have one of the following:
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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
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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)
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- 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
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