Prospective Randomised Multicenter Study for Therapy Optimization of Recurrent, Progressive Low Grade Non-Hodgkin Lymphomas and Mantle Cell Lymphomas
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Event Free Survival
研究概览
简要总结
The study addresses the question if a therapy with bendamustine plus rituximab is comparable (non inferior) with the well-tried combination of fludarabine plus rituximab with regard to event free survival (EFS) in recurrent low malignant Non-Hodgkin and mantle cell lymphomas.
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
- •Recurrent disease (remission duration minimum 3 months), independent of type or quantity of prior therapies, except of Rituximab containing regimens, or if remission duration is > 1 year after Rituximab containing regimen, or refractory to prior therapy (progression under therapy or during 3 months after completion), except refractory disease to purin analogs or Bendamustine
- •Need for therapy, except mantle cell lymphomas
- •Stadium II (bulky disease, 7.5 cm), II 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, potentially curative radiation therapy
- •Patients refractory to Rituximab containing regimens
- •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
- •Active auto immunohemolytic anemia (AIHA)
- •HIV positive patients
- •Active hepatitis infection
- •Severe psychiatric diseases
- •No compliance or non-compliance to be expected
- •Pregnant or breast feeding women
- •Anamnestic malignancies or secondary malignancies, not proven
- •Cured/curable by surgery
研究组 & 干预措施
Bendamustine plus Rituximab
Bendamustine 90 mg/m² d 1+2 + Rituximab 375 mg/m² d 1 q4w
干预措施: Bendamustine plus Rituximab (Drug)
Fludarabine plus Rituximab
Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4w
干预措施: Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4w (Drug)
结局指标
主要结局
Event Free Survival
时间窗: Observation till event or death, minimum 1 year
From date of randomization until the date of first documented progression, date of detection of a secondary malignancy or date of death from any cause, whichever came first. Minimum 1 year
次要结局
- Remission Rates(Observation till event or death, minimum 1 year)
研究者
Jurgen Barth
Professor Mathias Rummel
University of Giessen