NCT00227695已完成3 期
Comparing Two Schedules of Rituximab Maintenance in Rituximab-Responding Patients With Untreated, Chemotherapy Resistant or Relapsed Follicular Lymphoma: A Randomized Phase III Trial
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 26
- 主要终点
- Event-free survival
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether giving rituximab over a short period of time is more effective than giving it over a long period of time in treating follicular non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying rituximab to see how well it works when given over a short period of time compared to when given over a long period of time in treating patients with follicular non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
Primary
- Compare the efficacy of induction therapy with rituximab followed by short- vs long-term maintenance therapy with rituximab, in terms of event-free survival, in patients with follicular non-Hodgkin's lymphoma.
Secondary
- Compare the safety of these regimens in these patients.
- Compare the pharmaeconomical aspects of these regimens in these patients.
- Compare the evolution of immunologic competence in patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed follicular lymphoma
- •Grade 1, 2, 3a, or 3b disease by WHO staging system
- •CD20-positive by immunohistochemistry
- •Previously untreated disease OR meets 1 of the following criteria for response to prior treatment:
- •Chemotherapy-resistant disease
- •Relapsed or progressive disease
- •Stable disease
- •At least 12 weeks since prior systemic treatment
- •At least 1 bidimensionally measurable lesion ≥ 11 mm by CT scan or MRI
- •No transformation to high-grade lymphoma secondary to low-grade follicular lymphoma
- •No prior or current CNS disease (i.e., CNS lymphoma or lymphomatous meningosis) 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:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •Cardiovascular
- •Ejection fraction ≥ 50% by echocardiography or MUGA
- •Immunologic
- •No acute or ongoing infection
- •No HIV infection
- •No active autoimmune disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 12 months after completion of the study treatment
- •No uncontrolled diabetes mellitus
- •No other medical condition that would preclude study participation
- •No other malignancy except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix
- •No other condition (e.g., geographic proximity) that would preclude study compliance and follow-up
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Radiotherapy
- •Prior rituximab allowed
- •Chemotherapy
- •See Disease Characteristics
- •Endocrine therapy
- •More than 4 weeks since prior regular administration of corticosteroids
- •Dose equivalent to ≤ 20 mg/day prednisone allowed for conditions other than lymphoma or lymphoma-related symptoms
- •No concurrent corticosteroids for prevention or treatment of side effects except acute life-threatening side effects
- •Radiotherapy
- •Prior radiolabeled anti-CD20 therapy (administered alone or in combination with cytostatic drugs) allowed provided patient has achieved partial or complete response after the therapy
- •At least 12 months since prior anti-CD20 therapy
- •Not specified
- •More than 30 days since prior systemic tumor therapy
- •More than 30 days since prior participation in another clinical trial
- 另有 1 项未显示
排除标准
- 未提供
研究组 & 干预措施
Arm B: Rituximab (5 years)
Active Comparator
Rituximab 375 mg/m2 every 2 months for 5 years or until PD, relapse or unacceptable toxicity
干预措施: rituximab (Biological)
Arm A: Rituximab every 2 months x4
Active Comparator
Rituximab 375 mg/m2 every 2 months x4
干预措施: rituximab (Biological)
结局指标
主要结局
Event-free survival
时间窗: at 10 years
次要结局
- Overall survival(at 10 years)
- Progression-free survival(at 10 years)
- Adverse reactions during and after maintenance treatment(10 years)
研究者
研究点 (26)
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