Rituximab, Bendamustine and Lenalidomide in Patients With Aggressive B-cell Lymphoma Not Eligible for High Dose Chemotherapy or Anthracycline-Based Therapy. A Phase I/II Trial.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 16
- 主要终点
- Maximum-tolerated dose (phase I)
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer cell 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 cell-killing substances to them. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Lenalidomide may stop the growth of cancer by blocking blood flow to the tumor. Giving rituximab together with bendamustine hydrochloride and lenalidomide may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of giving rituximab together with bendamustine hydrochloride and lenalidomide in treating patients with aggressive B-cell lymphoma.
详细描述
OBJECTIVES:
Primary
- To determine the maximum-tolerated dose of the combination of rituximab, bendamustine hydrochloride, and lenalidomide in patients with aggressive B-cell lymphoma not eligible for anthracycline-based first-line treatment or intensive regimens including high-dose therapy (HDT) followed by autologous stem cell transplantation (ASCT) in refractory or relapsing disease, or as treatment for patients relapsing after HDT with ASCT. (phase I).
- To identify the recommended dose of this regimen for a phase II study (phase I).
- To determine the efficacy and safety of this regimen in these patients (phase II).
Secondary
- To assess the quality of life (QOL) of patients treated with this regimen (phase II).
- To evaluate the usefulness and feasibility of the SAKK Cancer-Specific Geriatric Assessment (C-SGA) in patients treated with this regimen (phase II).
- To assess the association between WHO performance status, QOL indicators, and SAKK C-SGA scores (phase II).
- To describe changes in SAKK C-SGA scores from pre- to post-treatment and in QOL (phase II).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment with rituximab, bendamustine and lenalidomide
干预措施: rituximab (Biological)
Treatment with rituximab, bendamustine and lenalidomide
干预措施: bendamustine hydrochloride (Drug)
Treatment with rituximab, bendamustine and lenalidomide
干预措施: lenalidomide (Drug)
结局指标
主要结局
Maximum-tolerated dose (phase I)
时间窗: at the end of phase I (31 August 2011)
Dose-limiting toxicity (phase I)
时间窗: at 4 weeks.
Objective response (complete and partial response) (phase II)
时间窗: phase II (3 years)
次要结局
- Event-free survival (phase II)(up to 30 months for each patient.)
- Time to progression (phase II)(up to 30 months for each patient.)
- Association between WHO performance status, QOL indicators, and SAKK C-SGA scores(End of phase II (excluding follow-up) at 3 years.)
- Usefulness and feasibility of the SAKK C-SGA(End of phase II (excluding follow-up) at 3 years.)
- Overall survival (phase II)(up to 30 months for each patient.)
- Progression Free Survival (PFS)(up to 30 months for each patient.)
- Adverse events according to NCI CTCAE v. 3.0(All AEs will be assessed according to NCI CTCAE v3.0 until 30 days after trial therapy end.)
- Response duration (phase II)(up to 30 months for each patient.)
- Quality of life(approx. 5 months for each patient.)