Phase III Study of CHOP-14 Plus or Minus Alemtuzumab in Peripheral T-cell Lymphoma of the Elderly
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 274
- 试验地点
- 1
- 主要终点
- Event free survival
研究概览
简要总结
Peripheral T cell lymphomas comprise 10-15% of all malignant lymphomas. The prognosis is significantly worse than that of aggressive B cell lymphomas. The prospects of elderly patients are especially poor, with an estimated disease free survival of only 25% after three years. Previous phase II trials have demonstrated a significant activity of the monoclonal anti CD52 antibody alemtuzumab in primary and relapsed T cell lymphoma. The investigators thus propose to investigate the value of adjuvant alemtuzumab in combination with dose dense CHOP-14 in patients with previously untreated peripheral T cell lymphoma.
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
- 61 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all risk groups of peripheral T cell lymphoma
- •performance status ECOG 0-2
- •written consent
- •measurable disease
排除标准
- •stage I N without bulky disease
- •already initiated treatment
- •serious accompanying disorder or impaired organ function
- •bone marrow involvement >25%
- •HIV positivity
- •leukemic manifestation of lymphoma
- •simultaneous participation in another trial
- •platelets < 100 000/ mm, leukocytes < 2500 /mm
研究组 & 干预措施
Arm A
Chemotherapy with dose dense CHOP-14, 6 cycles
干预措施: chemotherapy (Drug)
Arm B
Chemotherapy with dose dense CHOP-14, 6-cycles, together with 30mg Alemtuzumab s.c. for the first 4 cycles
干预措施: alemtuzumab (Biological)
Arm B
Chemotherapy with dose dense CHOP-14, 6-cycles, together with 30mg Alemtuzumab s.c. for the first 4 cycles
干预措施: chemotherapy (Drug)
结局指标
主要结局
Event free survival
时间窗: 3 years
次要结局
- immune reconstitution after alemtuzumab CHOP(3 years)
- Rate of complete and partial remissions(4 months after inclusion)
- treatment related deaths(time of occurence)
- Overall survival(@ 3 years)
- protocol adherence(4 months of treatment)
研究者
Prof. Dr. Lorenz Trümper
Head of Departement of Haemtology and Oncology
University of Göttingen