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

Prior treatment

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

Other illness

• Patients with Down syndrome.

Other

• Patients with mature B-cell ALL that do not have a KMT2A rearrangement or patients with acute myelogenous (AML) or T-cell ALL.
• Inability or unwillingness of legal guardian/representative to give written informed consent

• Patient is ≤ 365 days of age at the time of diagnosis.
• Patient has newly diagnosed CD19 positive acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia. Subjects with bilineage or biphenotypic acute leukemia are eligible provided they express CD19. Patients with CD19 positive mature B-cell ALL who carry a KMT2A rearrangement are eligible.
• Limited prior therapy, including hydroxyurea for 72 hours or less, systemic glucocorticoids for one week or less, cytarabine for 72 hours or less, one dose of vincristine, and one dose of intrathecal chemotherapy.
• Written informed consent following Institutional Review Board, NCI, FDA, and OHRP Guidelines.