2023-507291-52-00招募中2 期
A PHASE II STUDY OF CHLORAMBUCIL IN COMBINATION WITH SUBCUTANEOUS RITUXIMAB FOLLOWED BY MAINTENANCE THERAPY WITH SUBCUTANEOUS RITUXIMAB IN PATIENTS WITH EXTRANODAL MARGINAL ZONE B-CELL LYMPHOMA OF MUCOSA ASSOCIATED LYMPHOID TISSUE (MALT LYMPHOMA)
Association International Extranodal Lymphoma Study Group (IELSG)37 个研究点 分布在 2 个国家目标入组 106 人开始时间: 2024年10月1日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 106
- 试验地点
- 37
- 主要终点
- Complete Remission rate at the end of induction phase (6 months)
研究概览
简要总结
Aim of the study is to assess the therapeutic safety and activity of the combination of Chlorambucil and Rituximab given for 6 months, followed by 2 years maintenance treatment with subcutaneous Rituximab alone in MALT lymphomas.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Histologically proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type either de novo, or relapsed following local therapy (including surgery, radiotherapy and antibiotics for H. pylori-positive gastric lymphoma) arisen at any extranodal site
- •Measurable or evaluable disease
- •Any stage (Ann Arbor I-IV)
排除标准
- •Evidence of histologic transformation to a high grade lymphoma
- •Prior chemotherapy
- •Prior radiotherapy in the last 6 weeks
- •Prior immunotherapy with any anti-CD20 monoclonal antibody
- •Known HIV, active Hepatitis B (HB) and Hepatitis C (HC) infections
结局指标
主要结局
Complete Remission rate at the end of induction phase (6 months)
Complete Remission rate at the end of induction phase (6 months)
次要结局
- Response Rate (Complete and partial remission rates) at the end of induction phase ( 6 months from study entry)
- Progression Free Survival
- Event-free-survival (EFS) at 5 years
- Overall survival
- Response duration
- Acute and long-term toxicity
研究者
IELSG Operations Office
Scientific
Association International Extranodal Lymphoma Study Group (IELSG)
研究点 (37)
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