Therapy of Nodal Follicular Lymphoma (Grade I/II) Clinical Stage I or II Using Involved Field Radiotherapy in Combination With Rituximab
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 17
- 主要终点
- progression free survival
研究概览
简要总结
Combination of involved field radiotherapy for the control of macroscopic disease and CD20 antibody Rituximab for the control of microscopic remainders in other regions in patients with early stage nodal follicular lymphoma /grade I or II). Evaluation of DFSl and toxicity.
详细描述
The MIR (Mabthera(R) and Involved field Radiation) study is a prospective multicenter trial combining systemic treatment with the anti CD20 antibody Rituximab (Mabthera(R)) in combination with involved field radiotherapy (30 - 40 Gy). This trial aims at testing the combination's efficacy and safety with an accrual of 85 patients.Primary endpoint of the study is progression free survival. Secondary endpoints are response rate to Rituximab, complete remission rate at week 18, relapse rate, relapse pattern, relapse free survival, overall survival, toxicity and quality of life.
More details: Witzens-Harig M, Hensel M, Unterhalt M, Herfarth K. Treatment of limited stage follicular lymphoma with Rituximab immunotherapy and involved field radiotherapy in a prospective multicenter Phase II trial-MIR trial. BMC cancer. 2011; 11: 87.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •verified follicular lymphoma grade 1 or 2
- •only nodal involvement (incl. Waldeyer) clinical stage I or II
- •largest tumor ≤ 7 cm
- •adequate bone marrow reserves
排除标准
- •Follicular lymphoma grade 3
- •buky disease (>7 cm)
- •involvement of the spleen
- •neoplasia in PMH (except: basalioma, spinalioma)
- •Immunodeficiency syndromes, viral hepatitis, connective tissue disease
- •severe psychiatric disease
- •pregnancy or breast feeding
- •known allergies against foreign proteins
结局指标
主要结局
progression free survival
时间窗: 2 years
次要结局
- QoL(2 yrs)
- Relapse rate, Relapse pattern, DSF(2 yrs)
- Response to Rituximab(7 weeks)
- Rate of CR(18 weeks)
- Toxicity (CTC Vers. 3)(2 yrs)
- Overall survival(2 yrs)
研究者
Klaus Herfarth, MD
Prof. Dr. K. Herfarth
Heidelberg University