Front-line High-dose Chemotherapy (HDT) Combined With Rituximab for Adults With Aggressive Large B-cell Lymphoma (DLBCL) : Goelams 074 Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- CR rate after 3 high dose chemotherapy courses
研究概览
简要总结
A prospective pilot trial was proposed to patients with DLBCL, with IH or high adjusted IPI, up to the age of 60 y.o. This program consisted of 2 courses of high-dose R-CHOP-like regimen, followed by a course of high-dose methotrexate with cytarabin. For patients who achieved at least a PR, ASCT started with a BEAM regimen.
详细描述
Superiority of HDT with autologous stem cell transplantation (ASCT) in the upfront treatment of poor-risk DLBCL remains an option for intermediate-high (IH) or high IPI young adults. We updated results of the prospective trial Goelams 074 to evaluate long-term efficacy and toxicity in 42 patients who underwent HDT with ASCT.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 60 y.o
- •Aggressive Large B-Cell Lymphoma (CD20+)
- •Ann Arbor stage III, IV
- •IH or high adjusted IPI
- •signed inform consent
排除标准
- •Age < 18 ou > 60 y.o
- •other type of lymphoma
- •serology VIH +
- •other neoplasms apart from basal cell carcinoma or situ carcinoma
研究组 & 干预措施
HDT combined with rituximab before ASCT
The study treatment consisted on 2 courses of high-dose R-CHOP-like regimen, followed by a course of high-dose methotrexate with cytarabin. For patients who achieved at least a PR, ASCT started with a BEAM regimen.
干预措施: Rituximab (Drug)
结局指标
主要结局
CR rate after 3 high dose chemotherapy courses
时间窗: safety/efficacy of chemotherapy treatment
次要结局
- CR and PR rate at the end of the study treatment(safety/efficacy of treatment30 days after the end of post ASCT aplasia)
- PFS,EFS and OS(safety/efficacy of study treatment)
- Tolerance of Rituximab combined with chemotherapy(safety/efficacy of immunotherapy combined with chemotherapy treatment)