Phase III Study of Combination Chemotherapy in Children With T Cell and Pre-B Cell Non-Hodgkin's Lymphoma

OBJECTIVES:

• Assess the event free survival at 2 and 5 years of children with T cell or pre-B cell non-Hodgkin's lymphoma treated with a sequential induction regimen, a consolidation regimen, a reintensification regimen, and a maintenance regimen.
• Assess the rate of local relapse at 2 and 5 years of these children after receiving this treatment.
• Determine the toxicity of this treatment in these patients.
• Determine the overall survival of these children at 5 years after receiving this treatment.

OUTLINE: This is a multicenter study.

Patients receive 5 weeks of induction chemotherapy consisting of prednisone IV twice a day on days 1-28, then decreasing in dose on days 29-35; vincristine IV on days 8, 15, 22, and 29; cyclophosphamide IV over 1 hour on day 8; daunorubicin IV over 24 hours on days 15, 22, and 29; asparaginase IV or IM on days 16, 18, 20, 23, 25, 27, 30, and 32; and methotrexate IV over 3 hours on day 8. Patients also receive methotrexate and methylprednisolone intrathecally (IT) on days 1, 4, 9, and 15.

Patients with a response over 50% proceed to 4-8 weeks of consolidation therapy. This regimen consists of vincristine IV on day 15, cyclophosphamide IV over 1 hour followed by methotrexate over 3 hours on day 1, cytarabine IV on days 2-5 and 8-11, asparaginase IV or IM on days 16 and 23, and methotrexate IV over 3 hours on day 15. Patients also receive methotrexate and methylprednisolone IT on days 2 and 16. Patients who achieve complete remission after 4 weeks repeat consolidation therapy for another course.