NCT00151281已完成2 期
Phase II Trial of Anti-Angiogenic Therapy With RT-PEPC in Patients With Relapsed Mantle Cell Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Overall Survival and Progression Free Survival
研究概览
简要总结
Primary Objective:
Evaluate the clinical activity of the RT-PEPC combination regimen (rituximab, thalidomide, and prednisone, etoposide, procarbazine, cyclophosphamide) in patients with relapsed mantle cell lymphoma. Specifically, response rate (RR) and time to disease progression (TTP) will be assessed.
Secondary Objectives:
- Assess the toxicity profiles of RT-PEPC treatment in patients with relapsed mantle cell lymphoma.
- Prospectively characterize the angiogenic profile of patients with mantle cell lymphoma during treatment with RT-PEPC. The dynamics of the angiogenic profile will be correlated with clinical response to RT-PEPC therapy.
- Assess the quality of life of patients receiving RT-PEPC treatment
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
- •Histologically confirmed diagnosis of mantle cell Non-Hodgkin's Lymphoma with characteristic immunophenotypic profiles: CD5(+),CD23(-), CD19(+) or CD20(+), cyclin D1(+), and CD10(-)
- •Patient has persistent / recurrent disease after standard chemotherapy
- •Patient has not received either standard or investigational drugs within the last 3 weeks
- •Available frozen tumor tissue obtained since completion of last prior therapy (rebiopsy if needed)
- •Patient has measurable disease as defined by a tumor mass > 1.5 cm in one dimension
- •Age > 18 years
- •Absolute granulocyte count > 1000 cells/mm3
- •Platelet count > 50,000 cells/mm3
- •Creatinine < 2.0 x ULN
- •Total bilirubin < 2.0 x ULN
- •Patient has KPS > 50%
- •Patient agrees to use birth control if of reproductive potential
排除标准
- •Known central nervous system (CNS) involvement by lymphoma
- •Known HIV disease
- •Known peripheral neuropathy > grade 2
- •Patient is pregnant or nursing
- •Patient has had major surgery within the last 3 weeks
- •Patient is receiving other investigational drugs
研究组 & 干预措施
Study Treatment Arm
Experimental
干预措施: PEPC (Drug)
Study Treatment Arm
Experimental
干预措施: Thalidomide (Drug)
Study Treatment Arm
Experimental
干预措施: Rituximab (Drug)
结局指标
主要结局
Overall Survival and Progression Free Survival
时间窗: 38 months
measured by overall Response Rate (ORR), which includes Complete response and partial response.
次要结局
- Asses the Toxicity Profiles(38 months)
- Dynamic Levels of Plasma VEGF(38 months)
- The Quality of Life (QoL) of Patients Receiving RT-PEPC Treatment(baseline, every 2 months until Month 6, and every 6 months until disease progression)
研究者
研究点 (1)
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