Study of R-ACVBP Regimen Supported by Pegfilgrastim in Previously Untreated Patients Aged From 18 to 60 Years With High-Risk Diffuse Large B-Cell Lymphoma (Age-adjusted Ipi >or= 2)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- To evaluate the optimal combined dose intensity of the drug regimen
研究概览
简要总结
Evaluation of the efficacy of a single injection of Pegfilgrastim (6mg) administered at day 3 of each cycle of R-ACVBP regimen during 4 cycles in patients with CD20+ diffuse large B-cell lymphoma presenting at least 2 adverse prognostic factor of the age-adjusted international prognostic index (Aa-IPI).
详细描述
This is a phase II, multicentric, open-label, non-randomized study, evaluating the efficacy of a single injection of Pegfilgrastim (6mg) administered at day 3 of each cycle of R-ACVBP regimen during 4 cycles in patients aged 18 to 60 years with previously untreated CD20+ diffuse large B-cell lymphoma presenting at least 2 adverse prognostic factor of the age-adjusted international prognostic index (Aa-IPI), and eligible for transplant.
It is anticipated that 60 subjects will be enrolled over 2 years (from 2004 to 2006), in a group sequential manner one planned interim analysis.
The duration of the treatment period is approximately 26 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
- Non Randomized
- 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 61 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with histologically proven CD20+ diffuse large B cell lymphoma (WHO Classification).
- •Age >18 and < 61 years, eligible for transplant.
- •Patient not previously treated.
- •With at least two prognostic factors of the Aa-IPI.
- •With a minimum life expectancy of 3 months.
- •Creatinin level ≤ 150mmol/l, total bilirubin level 30mmol/l and transaminases 2.5 maximum normal level, unless abnormalities are related to the lymphoma.
- •Neutrophils > 1.5 G/l and platelets > 100 G/l, unless if patient has a bone marrow infiltration.
- •Negative HIV, HBV and HCV serologies 4 weeks (except after vaccination).
- •Having previously signed a written informed consent.
排除标准
- •Any other histological type of lymphoma.
- •Any history of treated or non-treated indolent lymphoma.
- •Central nervous system or meningeal involvement by lymphoma.
- •Contra-indication to any drug contained in the chemotherapy regimens.
- •Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
- •Any serious active disease (according to the investigator's decision).
- •Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
- •Pregnant or lactating women or women of childbearing potential not currently practicing an adequate method of contraception.
- •Adult patient under tutelage.
结局指标
主要结局
To evaluate the optimal combined dose intensity of the drug regimen
次要结局
- Specific dose intensities, incidence of neutropenia and neutropenic fever, duration of severe neutropenia, complete response rate, event-free and overall survival