Rituximab in Hairy Cell Leukemia: a Multicenter Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CHU de Reims
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Complete hematologic response to rituximab therapy
研究概览
简要总结
Hairy-cell leukemia is a rare and indolent lymphoid disorder, representing 2% of all cases of lymphoid leukemias. Treatment of hairy-cell leukemia relies mainly on the purine analogs, cladribine and pentostatin, which have shown similar efficacy and constitute the gold standard of care either as front-line therapy or for relapsed patients.
However, despite the remarkable response rates obtained with purine analogs therapy, some patients will eventually relapse and the efficacy of these agents seems to decrease at each line of treatment. The addition of new molecules to purine analogs may improve the response rates and prevent relapse.
Rituximab is a chimeric IgG1 kappa-type monoclonal antibody directed against the CD20 molecule. It was first used in relapsed patients with hairy-cell leukemia more than 10 years ago and several series of patients treated with rituximab as monotherapy were published in the following decade, reporting response rates ranging from 25% to 80%.
详细描述
Aims of the study were :
- to assess the overall efficacy of rituximab in a cohort of unselected patients with hairy-cell leukemia
- to identify factors associated to treatment response, to duration of treatment response and to patient survival in a cohort of unselected patients with hairy-cell leukemia
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with hairy-cell leukemia diagnosed between July 2002 and September 2012
- •patients had received at least 3 subsequent injections of rituximab
- •aged > 18 years
排除标准
- 未提供
结局指标
主要结局
Complete hematologic response to rituximab therapy
时间窗: Month 6
Complete hematologic response was defined as * the recovery of normal blood counts (absolute neutrophil count ≥ 1.5x109/L, platelet count ≥ 100x109/L and hemoglobin level ≥ 120g/L for men and ≥ 110g/L for women) * the absence of circulating cells of hairy-cell leukemia and clinical signs of hairy-cell leukemia
次要结局
未报告次要终点