TINI 2: Total Therapy for Infants with Acute Lymphoblastic Leukemia II

Inclusion Criteria:

• Patient is ≤ 365 days of age at the time of diagnosis.

• Patient has newly diagnosed CD19 positive acute lymphoblastic leukemia (ALL) oracute undifferentiated leukemia. Subjects with bilineage or biphenotypic acuteleukemia are eligible provided they express CD19. Patients with CD19 positive matureB-cell ALL who carry a KMT2A rearrangement are eligible.

• Limited prior therapy, including hydroxyurea for 72 hours or less, systemicglucocorticoids for one week or less, cytarabine for 72 hours or less, one dose ofvincristine, and one dose of intrathecal chemotherapy.

• Written informed consent following Institutional Review Board, NCI, FDA, and OHRPGuidelines.

Exclusion Criteria:

• Patients with prior therapy, other than therapy specified in inclusion criteria.

• Patients with mature B-cell ALL that do not have a KMT2A rearrangement or patientswith acute myelogenous (AML) or T-cell ALL.

• Patients with Down syndrome.

• Inability or unwillingness of legal guardian/representative to give written informedconsent