A Randomized Trial to Evaluate Early High Dose Therapy and Autologous Bone Marrow Transplantation as Part of Planned Initial Therapy for Poor Risk Intermediate/High Grade NHL
OBJECTIVES: I. Assess the value of early intensification with autologous bone marrow
transplantation or stem cell support in patients with poor prognosis intermediate or high
grade non-Hodgkin's lymphoma.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by age (under 50
vs 50 and over), bone marrow involvement (yes vs no), and country. All patients receive
cyclophosphamide, doxorubicin, and vincristine on day 1 and prednisone on days 1-5. Courses
repeat every 21 days. Patients receive a minimum of 6 courses of treatment in the absence of
disease progression and unacceptable toxicity. Arm I: Patients receive carmustine IV over 2
hours on day 1 in week 9 or 10. Etoposide and cytarabine IV are administered over 30 minutes
on days 2-5. Melphalan IV is administered over 5 minutes on day 6. Patients receive
cryopreserved bone marrow or peripheral blood stem cells on day 7. Arm II: Patients continue
conventional therapy. Patients are followed at 8-9 weeks and 6 months.
PROJECTED ACCRUAL: This study will accrue 500 patients.
Allocation: Randomized, Primary Purpose: Treatment
David C. Linch
University College London Hospitals
United States: Federal Government