A Randomized, Phase III Trial to Determine the Effect of Consolidation With Rituximab (IDEC C2B8-Mabthera) in Patients With CD20+ Follicular or Mantle Cell Lymphoma Having Received Induction Therapy With Rituximab Weekly x 4
rituximab
Hemic and Lymphatic Diseases+7
+ Immune System Diseases
+ Immunoproliferative Disorders
Treatment Study
Summary
Study start date: January 1, 1998
Actual date on which the first participant was enrolled.OBJECTIVES: Assess the clinical efficacy of consolidation treatment with rituximab in terms of response rate in patients with follicular (closed to accrual 9/18/00) or mantle cell lymphoma. Compare the event free survival of patients after induction with or without consolidation. Compare the tolerability of these two treatment regimens by these patients. OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified according to participating center, histology (follicular (closed to accrual 9/18/00) vs mantle cell), status of disease (de novo vs relapsed vs resistant), response after induction (stable disease vs partial or complete response), and treatment status (treated vs untreated). All patients receive induction therapy consisting of rituximab IV over 3-5 hours once a week during weeks 1-4. Patients are then randomized to one of two treatment arms. Arm I: Patients are observed. Arm II: Patients receive rituximab IV over 3-5 hours once a week during weeks 12, 20, 28, and 36. Patients are followed weekly for the first month; every 8 weeks for the next 8 months; then at 12, 18, and 24 months; and then annually for the next 3 years. PROJECTED ACCRUAL: A total of 240 patients (120 per arm) will be accrued for this study within 3-4 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.240 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 120 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Histologically proven CD20 positive follicular (closed to accrual 9/18/00) or mantle cell lymphoma Untreated "de novo" disease OR Chemotherapy resistant disease OR Relapsing disease Bidimensionally measurable disease No symptomatic CNS disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) No hepatitis B or C Renal: Creatinine no greater than 2 times ULN Cardiovascular: Ejection fraction at least 50% Other: Not pregnant or nursing Fertile patients must use effective contraception No active opportunistic infections HIV negative No prior malignancy within 5 years except adequately treated carcinoma in situ of the cervix or localized nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: No prior antibody based therapy Chemotherapy: At least 4 weeks since prior chemotherapy (at least 6 weeks since nitrosoureas) and recovered No concurrent chemotherapy Endocrine therapy: At least 4 weeks since prior corticosteroids, unless chronic dose no greater than 20 mg/day for nonlymphoma related condition No other concurrent corticosteroids Radiotherapy: Not specified Surgery: Not specified
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 10 locations
Office of Walter Weber-Stadelman
Basel, SwitzerlandUniversity Hospital
Basel, SwitzerlandOspedale San Giovanni
Bellinzona, Switzerland