Prospective Randomized Multicenter Study in First-line Treatment of Advanced progredIeNT Follicular And Other IndoleNt and Mantle Cell Lymphomas
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,272
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
The purpose of this study is to determine if an extended maintenance therapy with Rituximab in follicular and a maintenance therapy in other indolent and mantle cell lymphomas has advantages compared to a shorter or no maintenance therapy.
详细描述
Results from several randomised studies show a clinical benefit of a maintenance therapy with rituximab in follicular lymphomas. The advantage of a maintenance therapy in other indolent and mantle cell lymphomas is - due to the lower incidence of these diseases- not well investigated.
This study tries to determine the significance of an extended maintenance therapy with rituximab in follicular lymphomas and the significance of a maintenance therapy other indolent and mantle cell lymphomas compared to observation.
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 80 Years（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-Lymphoma of the following entities:
- •Follicular Lymphoma Grade 1 and 2
- •Lymphoplasmocytic lymphoma / Immunocytoma (Morbus Waldenström) and small cell lymphocytic lymphoma (CLL without leukemic hemogram)
- •Marginal zone lymphoma, nodal and extra nodal
- •Mantle cell lymphoma
- •No prior therapy with cytotoxics, interferon or monoclonal antibodies
- •Need for therapy, except mantle cell lymphomas
- •Stadium III or IV or Stadium with II bulky disease (> 7 cm diameter, or 3 lesions > 5 cm)
- •General condition WHO 0-2
- •Age min. 18 years, max. 80 years
- •Negative pregnancy test, contraceptives mandatory for women of child-bearing age
- •Actual histology, not older than 6 months required
- •Written informed consent
排除标准
- •Patients not meeting the inclusion criteria above
- •Possibility of a primary radiation therapy with curative intention
- •Pretreatment, except a single, localized radiation therapy (radiation field not larger than 2 adjacent lymph node regions)
- •Co-morbidities, excluding a therapy according to the protocol:
- •severe, medicinal not adjustable hypertension
- •severe limited capacity of the heart (NYHA III or IV), the lung (WHO-Grade III or IV), the liver and kidneys (creatinin > 2 mg/dl, GOT and GPT or bilirubin 3 x ULN), except if caused by lymphoma
- •severe, medicinal not adjustable diabetes mellitus
- •active autoimmune disease
- •active infection, requiring antibiotic therapy
- •Patients with proven HIV-infection
- •Active replicating hepatitis-Infection
- •Severe psychiatric diseases
- •Lacking or anticipated non-compliance
- •Known hypersensitivity against the active components or additives or mouse- proteins
- •Pregnant or nursing women
- •Patients with a secondary malignancy or malignant disease in his history if, curative surgery can not be doubtless assured .
研究组 & 干预措施
Rituximab
Follicular Lymphomas: Rituximab 375 mg/m² for additional 2 years after 2 years of standard maintainance All other lymphomas: Rituximab 375 mg/m² for 2 years as maintainance. From 2014 only Morbus Waldenstroem: Rituximab 1.400 mg absolute s. c. injection
干预措施: Rituximab (Drug)
Standard
Rituximab / Observation
干预措施: Rituximab / observation (Drug)
结局指标
主要结局
Progression free survival
时间窗: 5 years and ongoing
Time from randomization until progress or death of any course
次要结局
- Remission rate and duration; event free-, progression free-, disease free- and over all survival(5 years and ongoing)
研究者
Jurgen Barth
Professor Mathias Rummel
University of Giessen