Trial Information

Marrow-Ablative Chemo-Radiotherapy and Autologous Stem Cell Transplantation Followed by Interferon-Alpha Maintenance Treatment Versus Interferon-Alpha Maintenance Treatment Alone After a Chemotherapy-Induced Remission in Patients With Stages III or IV Follicular Non-Hodgkin's Lymphoma. A Prospective, Randomized, Phase III Clinical Trial.

OBJECTIVES: I. Compare the progression free and overall survival, toxicity, and mortality of
marrow ablative chemo/radiotherapy in addition to peripheral blood stem cell transplantation
and interferon alfa maintenance therapy versus interferon alfa maintenance therapy alone in
patients with follicular non-Hodgkin's lymphoma.

OUTLINE: This is a randomized study. All patients receive 8 courses of
cyclophosphamide/vincristine/prednisone (CVP) chemotherapy. Cyclophosphamide and vincristine
IV are given on day 1, along with oral prednisone on days 1-5. Courses are repeated every 3
weeks. Patients are randomized to receive one of two treatments 4 weeks after completion of
CVP chemotherapy if a partial or complete response is achieved and there are less than 15%
monoclonal B-lymphocytes in the bone marrow. Patients randomized to arm I receive interferon
alfa subcutaneously 3 times per week for a maximum of 3 years. Patients randomized to arm II
receive cyclophosphamide IV followed by subcutaneous filgrastim (granulocyte
colony-stimulating factor; G-CSF). Leukapheresis begins after leukocyte, platelet, and CD34+
levels recover and lasts 3-4 hours on 2-3 consecutive days. If an insufficient number of
stem cells are collected from the peripheral blood, bone marrow harvesting is performed.
After stem cell collection, a conditioning regimen consisting of cyclophosphamide IV on days
-4 and -3 and total body irradiation on day -1 is administered. Stem cells are infused on
day 0. If granulocyte and platelet counts recover within 8 weeks, patients receive
interferon alfa maintenance therapy as in arm I. Patients are followed every 4 months until
death.

PROJECTED ACCRUAL: A total of 469 patients will be accrued for this study within 5 years.