A European Randomized Multicenter Study of Interferon Alfa-2b Versus No Treatment After Intensive Therapy and Autologous Hematopoietic Stem Cell Transplantation for Relapsing Lymphoma Patients (Non-Hodgkin Lymphomas and Hodgkin's Disease)
OBJECTIVES: I. Determine the efficacy of interferon alfa-2b in reducing the relapse rate in
patients with recurrent or refractory Hodgkin's disease or non-Hodgkin's lymphoma in second
remission following high dose chemotherapy and autologous stem cell transplantation. II.
Compare the time to disease progression and survival in this patient population treated with
interferon alfa-2b vs no further treatment. III. Assess the tolerability of these treatment
regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
lymphoma subtype. Patients are randomized to one of two treatment arms. Arm I: Patients
receive no further therapy following high dose chemotherapy and autologous stem cell
transplantation. Arm II: Beginning 4 weeks after high dose chemotherapy and autologous stem
cell transplantation, patients receive interferon alfa-2b subcutaneously three times a week.
Treatment continues for 18 months in the absence of disease progression or unacceptable
toxicity. Patients are followed every 6 months until disease progression.
PROJECTED ACCRUAL: A total of 360 patients (180 per treatment arm) will be accrued for this
study within 4-5 years.
Allocation: Randomized, Primary Purpose: Treatment
Bertrand Coiffier, MD
Centre Hospitalier Lyon Sud
United States: Federal Government