Lenalidomide Plus R-CHOP for CNS Relapse Prophylaxis in Diffuse Large B-cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- The 2-year central nervous system relapse rates
研究概览
简要总结
This is an open-label, multicenter, phase 2 trial to explore the efficacy and safety of the combination of lenalidomide and R-CHOP for preventing the CNS relapse in the high-risk diffuse large B cell lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-72 years histologically confirmed DLBCL High risk for CNS recurrence: CNS-IPI:4-6 or involvement of testicular, kidneys or adrenal glands.
- •No pregnancy plans during treatment
排除标准
- •Evidence of CNS involvement, Transformed lymphoma, Primary mediastinal B-cell lymphoma EBV+DLBCL, Secondary malignancy, HIV positive, Creatinine > 2.0 mg/dl Intending to hematopoietic stem cell transplantation history of severe thrombus Pregnant or lactating women
研究组 & 干预措施
Lenalidomide
Lenalidomide orally 25 mg per day was administered on days 1 through 10 of each cycle and delivered concomitantly with standard dose R-CHOP-21 regimen (rituximab 375 mg/m2, cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2 or Liposome doxorubicin 30mg/m2, vincristine 1.4 mg/m2 [capped at 2.0 mg], all on day 1; prednisone 100 mg per day on days 1 through 5). All patients received aspirin 100mg per day prophylaxis throughout, unless they were on therapeutic dose warfarin or low molecular weight heparin for intercurrent conditions. The treatment continued for a maximum of six to eight cycles or until disease progression. Tumor lysis prophylaxis, antiemetics, and supportive care were standard of care.
干预措施: Lenalidomide (Drug)
结局指标
主要结局
The 2-year central nervous system relapse rates
时间窗: two year
The 2-year central nervous system relapse rates
次要结局
- The 2-year overall survival(two year)
- Incidence of treatment-emergent adverse events(two year)
- The 2-year progression-free survival(two year)
研究者
Ru Feng
Professor
Nanfang Hospital, Southern Medical University