A Phase II Clinical Trial of Lenalidomide for T-cell Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 7
- 主要终点
- overall response rate
研究概览
简要总结
T-cell Non-Hodgkin's lymphomas are a group of cancers that are usually treated with chemotherapy, radiation therapy, or occasionally surgery. T-cell lymphomas are relatively uncommon and therefore not well studied. Treatment approaches are patterned after the more common B-cell lymphomas. T-cell lymphomas are more likely to relapse following standard therapy than are B-cell lymphomas. New therapies are needed for T-cell lymphomas. In this study, we will administer the drug called lenalidomide as a pill to patients with T-cell lymphoma. The goals are to determine if the drug can induce regression of the cancer, and to determine if the treatment is well tolerated in this patient group. This study will take place at six cancer centres across Canada.
详细描述
Background: T-cell lymphomas comprise 10-15% of all non-Hodgkin's lymphomas and include a variety of histological subtypes. These diseases have variable clinical behaviour, response to therapy, and long-term outcomes. In general, T-cell lymphomas are characterized by inferior response to therapy and prognosis compared to the more common B-cell lymphomas. Because T-cell lymphomas are uncommon, they are not generally well studied and current treatment approaches are borrowed from established protocols for B-cell lymphoma. New therapies are needed for T-cell lymphoma, and should be studied separately for their effectiveness in T-cell lymphoma.
Lenalidomide (CC-5013, Revlimid; Celgene Corporation) is an oral thalidomide analogue with anti-cancer activity. Lenalidomide is generally well tolerated, with rash, myelosuppression and venous thrombosis being the most notable and common potential side effects. Lenalidomide has demonstrated impressive anti-cancer activity against mycosis fungoides (cutaneous T-cell lymphoma), multiple myeloma, chronic lymphocytic leukemia and myelodysplasia. The drug is currently under review by Health Canada as a potential new standard therapy for multiple myeloma. We are encouraged by the efficacy and tolerability of lenalidomide in patients with related diseases, to study its role in the treatment of T-cell lymphomas other than mycosis fungoides.
Primary Objective: To determine the overall response rate to single agent lenalidomide at standard doses (25 mg po daily for 21 days of a 28-day cycle), as a treatment for T-cell lymphoma.
Secondary Objectives: To determine the complete response rate, time to progression, overall survival and tolerability for patients with T-cell lymphoma treated with lenalidomide.
Study Design: A multi-centre, Canadian, Phase II, investigator-initiated clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •T-cell lymphoma (excluding mycosis fungoides)
- •WHO performance status 0-2
- •measurable lesions
- •acceptable hematological and biochemical parameters
- •previously treated OR untreated but not suitable for standard therapy
排除标准
- •viral hepatitis
结局指标
主要结局
overall response rate
时间窗: every 3 months
Defined by the Cheson criteria for response in lymphoma and will be expressed as percentages
次要结局
- complete response rate(every 3 months)
- Time To Progression [TTP](every 3 months)
- survival(every 3 months)
- safety(every 3 months)