Phase II study of hyper-CVAD followed by nelarabine consolidation in newly diagnosed patients with T cell acute lymphoblastic leukemia/lymphoblastic lymphoma (ALL/LL).

6524 Background: Although current chemotherapy regimens like hyper-CVAD result in a high percentage of complete remissions (CR) in T-ALL/LL, almost 50% of the patients (pts) relapse. Nelarabine, a deoxyguanosine analogue, has demonstrated clinical activity as a single agent in relapsed/refractory T cell lymphoid malignancies. The goal of this study was to determine wether the addition of Nelarabine to hyper-CVAD can improve long-term outcome of pts with newly diagnosed T-ALL/LL. Methods: Nelarabine was given at 650 mg/m2 IV daily for 5 days every 28 days for two courses following the completion of hyper-CVAD (fractionated cyclophosphamide, vincristine, doxorubicin and dexamethasone alternating with methotrexate and high-dose cytarabine for a total of 8 courses) and prior to the POMP maintenance (vincristine, prednisone, 6-mercaptopurine and methotrexate). Two more courses of nelarabine at the same dose were given during courses 6 and 7 of the POMP maintenance. Central nervous system prophylaxis consisted ...