A Multicentre, Randomized Phase III Study of Thalidomide Maintenance Treatment in Patients With Diffuse Large B-cell Lymphoma
试验速览
- 阶段
- 3 期
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- Relapse-free survival
研究概览
简要总结
This is a randomized, multi-center,phase III study to evaluate the ability of thalidomide maintenance therapy to prolong relapse-free survival in diffuse large B cell lymphoma(DLBCL).
详细描述
This is a randomized, phase III study to evaluate the ability of thalidomide maintenance therapy to prolong relapse-free survival(RFS), in diffuse large B cell lymphoma(DLBCL).Patients will be enrolled after successful standard induction therapy (CR or CRu following standard R-CHOP-like therapy with 8 infusions of rituximab plus CHOP-like chemotherapy (4-8 cycles). Patients will be followed until an event occurs as defined in the protocol. To evaluate the clinical efficacy of thalidomide maintenance therapy as compared to observation in patients with DLBCL who have achieved a complete remission after appropriate first-line therapy, measured by RFS, 226 patients with DLCBL will be recruited.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NCCN-IPI>1,
- •Known IPI, cell of origin and DHL at time of diagnosis,
- •Negative pregnancy test,
- •Men must agree not to father a child during the therapy,
- •6 to 8 cycles R-CHOP/like, total of 8 x Rituximab,
排除标准
- •Transformed lymphoma,
- •Secondary malignancy,
- •HIV positive,
- •Evidence of CNS involvement,
- •Cardiac dysfunction (systolic ejection fraction <50%),
- •Creatinine > 2.0 mg/dl
研究组 & 干预措施
Thalidomide
Thalidomide 50mg daily by mouth( increase 50mg after 2 weeks if tolerated until 200mg/day) until disease progression or intolerance due to AEs.The dose could be reduced if the patient experienced grade 2 or higher AEs. Does reductions for AEs were recommended (200 mg daily to 100 mg daily, 100 mg daily to 50 mg daily).In patients intolerant of 50mg/day, thalidomide discontinuation was allowed.
干预措施: Thalidomide (Drug)
Observation
Observation
干预措施: Observation (Other)
结局指标
主要结局
Relapse-free survival
时间窗: 5 years
RFS was defined as the time between randomization and any documentation of relapse, death by any cause or last follow up.
次要结局
- Overall survival(5 years)
- Incidence of treatment-emergent adverse events(5 years)
研究者
Ru Feng
Professor
Nanfang Hospital, Southern Medical University