Multicentric Phase I/II Study for the Efficacy of a Combination of Rituximab, Gemcitabine and Oxaliplatin in Relapsed/Refractory Indolent Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Overall Remission Rate
研究概览
简要总结
The purpose of the phase I part is to determine the tolerability, the initial safety profile and maximum tolerated dose of oxaliplatin in combination with gemcitabine for indolent lymphoma. In the phase II part the investigators want to estimate the activity of gemcitabine and oxaliplatin in combination with rituximab for patients with relapsed/refractory indolent lymphoma.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Need for therapy in patients with relapsed/refractory patients
- •Histological proven diagnosis of an indolent B-cell lymphoma according to the World Health Organization (WHO) classification belonging to one of the following entities:
- •follicular lymphoma
- •mantle cell lymphoma
- •lymphoplasmacytic lymphoma
- •nodal or splenic marginal zone lymphoma
- •measurable disease
- •lymphoma specific therapy in the last four weeks
- •WHO performance grade 0, 1 or 2
- •Exclusion Criteria
- •Patients suitable for high dose therapy
- •Transformation in high grade lymphoma
- •Leukocytes < 1,5/nl or platelets < 100/nl (except due to lymphoma)
排除标准
- 未提供
研究组 & 干预措施
Rituximab, Gemcitabine and Oxaliplatin
Drug: Rituximab on day 0 or 1 of each 28-day cycle Drug: Gemcitabine on day 1 and 15 of each 28-day cycle Drug: Oxaliplatin on day 1 and 15 (in phase 1 dose escalation of Oxaliplatin in steps of 10 mg/m²) of each 28-day cycle
干预措施: Therapy with Rituximab, Gemcitabine and Oxaliplatin (Drug)
结局指标
主要结局
Overall Remission Rate
时间窗: end of therapy
次要结局
- Progression Free Survival(5 years)
- Median Overall Survival(5 years)
- Toxicity(5 years)
研究者
Martin Hoffmann
Dr. Martin Hoffmann, Klinikum Ludwigshafen
German Low Grade Lymphoma Study Group