Prospective Randomised Multicenter Study for Therapy Optimization (First Line) of Advanced Progredient, Low Malignant Non-Hodgkin Lymphomas and Mantle Cell Lymphomas
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 549
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
The study addresses the question if the first line therapy of low malignant and mantle cell lymphomas with bendamustine plus rituximab is comparable (non inferior) with CHOP plus rituximab with regard to progression free survival (PFS).
详细描述
The 4 agent chemotherapy (CTX) CHOP (cyclophosphamide, doxorubicin, vincristine prednisone) in combination with the monoclonal anti-CD20 antibody rituximab (CHOP-R) represents a standard CTX for the treatment of lymphomas of high or low malignancy. The combination of bendamustine and rituximab (B-R) is also highly effective with a more advantageous toxicity profile. If B-R could be shown to be non inferior to CHOP-R, this could improve the quality of life of the patient and possibly also the prognosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patients with histological verified CD20-positive B-Cell-Lymphomas of the following entities:
- •Follicular lymphoma grade 1 and 2
- •Immunocytoma and lymphoplasmocytic lymphoma
- •Marginal zone lymphoma, nodal and generalised
- •Mantle cell lymphoma
- •lymphocytic lymphoma (CLL without leucaemic characteristics)
- •non-specified/classified lymphomas of low malignancy
- •No prior therapy with cytotoxics,interferon or monoclonal antibodies
- •Need for therapy, except mantle cell lymphomas
- •Stadium III or IV
- •Written informed consent
- •Performance status WHO 0-2
- •Histology not older than 6 months
排除标准
- •Patients not establishing all above mentioned prerequisites
- •Option of a primary, potential curative radiation therapy
- •Pretreatment except a unique local delimited radiation (radiation fiel not expanding two adjacent lymph node regions
- •Comorbidities excluding a study conform therapy:
- •heart attack during the last 6 months
- •severe, medicinal not adjustable hypertonia
- •severe functional defects of the heart (NYHA III or IV)
- •lung (WHO grade III or IV), liver or kidney (creatinine > 2 mg/dl, GOT + GPT or bilirubin 3 x ULN, except caused by lymphoma.
研究组 & 干预措施
Bendamustine + Rituximab
Bendamustine 90 mg/m² d 1+2 + Rituximab 375 mg/m² d 1 q4w
干预措施: Bendamustine (Drug)
CHOP + Rituximab
Cyclophosphamid 750 mg/m² d 1 + Doxorubicin 50 mg/m² d 1 + Vincristin 1,4 mg/m² max. 2 mg d 1 + Prednison 100 mg absolute p.o. d 1-5 + Rituximab 375 mg/m² d 1 q3w
干预措施: Standard chemotherapy CHOP + Ritiximab (Drug)
结局指标
主要结局
Progression free survival
时间窗: observation 3 years or significant differences between two arms
次要结局
- Determination and comparison of remission rates, of toxicity, infectious complications, overall survival, EFS, TTNT, capacity of peripheral blood stem cell mobilization(ongoing)
研究者
Jurgen Barth
Study Group indolent Lymphomas (StiL)
University of Giessen