Phase I Trial of AVD Plus Lenalidomide (Revlimid) in Elderly Intermediate or Advanced Stage Hodgkin Lymphoma Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Dose limiting toxicities (DLT)
研究概览
简要总结
The purpose of this study is to determine within the scope of the trial what the maximum tolerated dose (MTD) of lenalidomide in combination with AVD should be.
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
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hodgkin Lymphoma, intermediate or advanced stage
- •Age >60 and <75 years
- •ECOG 2 or better
- •No major organ dysfunction
- •Ability to take aspirin or LMW Heparin
排除标准
- •HL as composite lymphoma
- •Prior use of lenalidomide
- •Prior use of chemo- or radiotherapy
研究组 & 干预措施
AVD-Rev
Patients with intermediate stage HL receive 4 cycles of AVD-Rev followed by 30 Gy IF-RT Patientes with advanced stage HL receive 6 to 8 cycles of AVD-Rev followed by 30 GY IF-RT depending on the FDG-PET results
干预措施: Doxorubicine (Drug)
AVD-Rev
Patients with intermediate stage HL receive 4 cycles of AVD-Rev followed by 30 Gy IF-RT Patientes with advanced stage HL receive 6 to 8 cycles of AVD-Rev followed by 30 GY IF-RT depending on the FDG-PET results
干预措施: DTIC (Drug)
AVD-Rev
Patients with intermediate stage HL receive 4 cycles of AVD-Rev followed by 30 Gy IF-RT Patientes with advanced stage HL receive 6 to 8 cycles of AVD-Rev followed by 30 GY IF-RT depending on the FDG-PET results
干预措施: Lenalidomide (Drug)
AVD-Rev
Patients with intermediate stage HL receive 4 cycles of AVD-Rev followed by 30 Gy IF-RT Patientes with advanced stage HL receive 6 to 8 cycles of AVD-Rev followed by 30 GY IF-RT depending on the FDG-PET results
干预措施: Vinblastine (Drug)
结局指标
主要结局
Dose limiting toxicities (DLT)
次要结局
- Overall response rate (ORR)
- Progression free survival (PFS)(2 years)
研究者
Prof. Dr. Andreas Engert
Prof.
University of Cologne