A Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Lenalidomide (Revlimid ®) in Combination With Dexamethasone in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 24
- 主要终点
- Tumor Response Rate
研究概览
简要总结
To evaluate the safety and efficacy of lenalidomide (Revlimid ®) in combination with dexamethasone in subjects with relapsed or refractory diffuse large B-cell lymphoma.
详细描述
Non-Hodgkin's lymphoma (NHL) can be divided into two general prognostic groups: the indolent lymphomas and the aggressive lymphomas. Indolent lymphomas have a relatively good prognosis, with median survival time as long as 10 years, but they are not usually curable in advanced stages. Aggressive NHL constitutes about half of all cases of NHL in North America and Western Europe. Of the aggressive lymphomas, diffuse large B-cell lymphoma (DLBCL) is the most common type, accounting for up to 30 percent of newly diagnosed cases. The aggressive type of NHL has a shorter natural history; approximately 50-60% of these subjects can be cured with combination chemotherapy regimens. Even with recent advances, many patients with advanced stage DLBCL are not cured with conventional therapy. This leaves a subset of subjects who will eventually relapse or who are refractory to treatment.
Due to the variation in the clinical behavior of the different types of aggressive NHL, it is important to test lenalidomide in DLBCL. Other studies are addressing the activity of lenalidomide in the other types of aggressive lymphomas, as well as in indolent NHL. It is important to test lenalidomide in combination therapy. This study is focused on treating subjects with relapsed or refractory DLBCL using oral lenalidomide in combination with oral dexamethasone.
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
- •Biopsy-proven diffuse large B-cell non-Hodgkin's lymphoma
- •Relapsed or refractory to previous therapy for non-Hodgkin's lymphoma
- •Measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter
- •ECOG performance score of 0,1 or 2
- •Willing to follow the pregnancy precautions
排除标准
- •Any of the following laboratory abnormalities.
- •Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L).
- •Platelet count < 60,000/mm3 (60 x 109/L).
- •Serum SGOT/AST or SGPT/ALT 5.0 x upper limit of normal (ULN).
- •Serum total bilirubin > 2.0 mg/dL (34 µmol/L).
- •Subjects who are candidates for and willing to undergo an autologous stem cell transplant.
- •History of active CNS lymphoma within the previous 3 months
- •Subjects not willing or unable to take DVT prophylaxis
- •History of other malignancies within the past year
- •Positive HIV or active Hepatitis B or C
研究组 & 干预措施
Single Arm
干预措施: CC-5013 (lenalidomide) (Drug)
Single Arm
干预措施: dexamethasone (Drug)
结局指标
主要结局
Tumor Response Rate
时间窗: One Year
Number of participants demonstrating complete or partial tumor response (Cheson B, Horning S, Coiffier B, Shipp M, Fisher R, Connors J, et al, Report of an international workshop to standardize response criteria for non-Hodgkins' lymphoma. J Clin Oncol.1999;17:1244-53). Study terminated prematurely. Analysis not conducted.
次要结局
- Tumor Control Rate(One Year)
- Duration of Response(One year)
- Time to Progression(One year)
- Progression-free Survival(One year)