Lymphoma Clinical Trial
Official title:
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
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Bone marrow transplantation may allow doctors to give higher
doses of chemotherapy drugs and kill more cancer cells. It is not yet known whether high
dose chemotherapy plus bone marrow transplantation is more effective than high dose
chemotherapy alone for intermediate- or high-grade non-Hodgkin's lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of high dose chemotherapy
with or without bone marrow transplantation in treating patients who have intermediate- or
high-grade non-Hodgkin's lymphoma.
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
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