Study of the Efficacy and the Safety of First Line Treatment With CHOP Plus Rituximab (R-CHOP) in Patients Aged 60 to 80 Years With Previously Untreated T-cell Angioimmunoblastic Lymphoma (AIL).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 4
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
To evaluate the efficacy and the safety of a front-line treatment combining CHOP regimen and rituximab in patients aged 60 to 80 years with previously untreated AIL.
详细描述
This is a multicentric, open-label, non-randomized clinical study, evaluating the efficacy and the safety of a front-line treatment combining CHOP regimen and rituximab in patients aged 60 to 80 years with previously untreated AIL.
It is anticipated that 25 subjects will be enrolled over 2 years (from 2005 / 2007).Analysis performed every 5 patients (based on triangular test).
The duration of the treatment period is approximately 25 weeks and patients are followed until Death.
The total Duration of the study is expected to be 2.5 years.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically proven T-cell angioimmunoblastic lymphoma (AIL) on lymph node biopsy.
- •Aged from 60 to 80 years.
- •Patient not previously treated (except corticosteroids providing they have been initiated less than 10 days before inclusion).
- •ECOG performance status 0 to
- •With a minimum of life expectancy > 3 months.
- •Negative HIV, HBV and HCV serological tests < 4 weeks (except after vaccination).
- •Having previously signed a written informed consent.
排除标准
- •Any other histological type of T-cell lymphoma.
- •Central nervous system or meningeal involvement by lymphoma.
- •Contra-indication to any drug included in the R-CHOP regimen.
- •Concurrent severe disease (according to the investigator's decision).
- •Active bacterial, viral or fungal infection.
- •Poor renal function (serum creatinine level > 150 µmol/L) or impaired liver function tests (total bilirubin level > 30 µmol/L, transaminases > 2.5 upper normal limits) unless they are related to the lymphoma.
- •Poor bone marrow reserve as defined by neutrophils < 1.5 x 109/L or platelets < 100 x 109/L, unless related to bone marrow infiltration.
- •Any history of cancer during the last 5 years, with the exception of non basal cell carcinoma of the skin or in situ carcinoma of the cervix.
- •Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
- •Patient under tutelage.
研究组 & 干预措施
Rituximab + CHOP
Rituximab + CHOP regimen Prednisone - Doxorubicine - Cyclophosphamide - Vincristine
干预措施: Doxorubicine (Drug)
Rituximab + CHOP
Rituximab + CHOP regimen Prednisone - Doxorubicine - Cyclophosphamide - Vincristine
干预措施: Cyclophosphamide (Drug)
Rituximab + CHOP
Rituximab + CHOP regimen Prednisone - Doxorubicine - Cyclophosphamide - Vincristine
干预措施: Vincristine (Drug)
Rituximab + CHOP
Rituximab + CHOP regimen Prednisone - Doxorubicine - Cyclophosphamide - Vincristine
干预措施: Rituximab (Drug)
Rituximab + CHOP
Rituximab + CHOP regimen Prednisone - Doxorubicine - Cyclophosphamide - Vincristine
干预措施: Prednisone (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: 8 months (4 cycles of treatment + 4 cycles of consolidation)
\[Complete response (CR), Complete response unconfirmed (CRu)\] after the end of treatment.
次要结局
- number of SAE(2 years)
- Event-free survival (EFS) relapse for complete responders, disease progression, early discontinuation of treatment for toxicity or modification of treatment.(2 years)
- Disease-free survival (DFS).(2 years)
- Overall survival (OS)(2 years)
- Time to progression (TTF)(2 years)