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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 20
研究概览
简要总结
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known which treatment regimen is more effective for lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of rituximab in treating patients who have follicular or mantle cell lymphoma.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •Not specified
- •Bilirubin no greater than 2 times upper limit of normal (ULN)
- •No hepatitis B or C
- •Creatinine no greater than 2 times ULN
- •Cardiovascular:
- •Ejection fraction at least 50%
- •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
- •Not specified
排除标准
- 未提供