Intensified Methotrexate, Nelarabine (Compound 506U78) and Augmented BFM Therapy for Children and Young Adults With Newly Diagnosed T-cell Acute Lymphoblastic Leukemia (ALL) or T-cell Lymphoblastic Lymphoma

This randomized phase III trial is studying different combination chemotherapy regimens and
their side effects and comparing how well they work in treating young patients with newly
diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. Drugs used in
chemotherapy work in different ways to stop the growth of cancer cells, either by killing the
cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)
may kill more cancer cells. It is not yet known which combination chemotherapy regimen is
more effective in treating T-cell acute lymphoblastic leukemia or T-cell lymphoblastic
lymphoma. After a common induction therapy, patients were risk assigned and eligible for one
or both post-induction randomizations: Escalating dose Methotrexate versus High Dose
Methotrexate in Interim Maintenance therapy, No Nelarabine versus Nelarabine in Consolidation
therapy. T-ALL patients are risk assigned as Low Risk, Intermediate Risk or High Risk. Low
Risk patients are not eligible for the Nelarabine randomization, Patients with CNS disease at
diagnosis were assgined to receive High Dose Methotrexate, patients who failed induction
therapy were assigned to receive Nelarabine and High Dose Methotrexate. T-LLy patients were
all assigned to escalating dose Methotrexate and were risk assigned as Standard Risk, High
Risk and induction failures. Standard risk patients did not receive nelarabine, High risk
T-LLy patients were randomized to No Nelarabine versus Nelarabine, and Induction failures
were assigned to receive Nelarabine.