Chimeric Anti-CD20 Monoclonal Antibody (Mabthera) in Remission Induction and Maintenance Treatment of Relapsed Follicular Non-Hodgkin's Lymphoma: A Phase III Randomized Clinical Trial - Intergroup Collaborative Study

Date de début de l'étude : 1 mai 1999

DISEASE CHARACTERISTICS: Histologically or cytologically proven stage III or IV follicular non-Hodgkin's lymphoma (NHL) Relapsed after or no response (no change/progressive disease) to no more than 2 adequate non-anthracycline-containing systemic chemotherapy regimens At least 2 months of single-agent therapy (e.g., chlorambucil) AND/OR At least 2 consecutive courses of polychemotherapy (e.g., cyclophosphamide, vincristine, and prednisone) or purine analogues Complete or partial remission or no change for at least 4 weeks after completion of prior therapy OR progression during one of a maximum of 2 prior therapy regimens CD20 positive At least 1 bidimensionally measurable mass No greater than 10,000,000/mL circulating tumor cells IgG levels at least 3 g/L No low-grade NHL transformed into intermediate- or high-grade NHL No symptomatic CNS lymphoma No bone marrow involvement only NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 2.5 times upper limit of normal (ULN) Alkaline phosphatase less than 2.5 times ULN Renal: Creatinine less than 2.5 times ULN BUN less than 2.5 times ULN Cardiovascular: No severe cardiac disease (i.e., severe heart failure requiring symptomatic treatment) Pulmonary: No severe pulmonary disease Other: No severe neurologic or psychiatric disease No severe metabolic disease Not pregnant Fertile patients must use effective contraception No prior malignancy within the past 5 years except nonmelanomatous skin cancer, carcinoma in situ of the cervix, or other cancer curatively treated with surgical therapy HIV negative No uncontrolled asthma or allergy requiring steroids No known hypersensitivity or prior anaphylactic reaction to murine proteins or any component of study drug PRIOR CONCURRENT THERAPY: Biologic therapy: No prior rituximab No prior allogeneic or autologous peripheral blood stem cell transplantation Concurrent filgrastim (G-CSF) for stem cell mobilization allowed Chemotherapy: See Disease Characteristics No prior anthracyclines or mitoxantrone No concurrent chemotherapy for stem cell mobilization Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified