Multicentre, Open Label, Phase II Trial to Evaluate the Efficacy and Safety of Treatment With Rituximab in Patients Suffering From Follicular Non-Hodgkin's Lymphoma (FNHL) With Residual Minimal Disease After Autologous Transplantation of hematopoïetic Stem Cell (Bone Marrow or Peripheral Blood)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Normalization of B-cell lymphoma 2 levels
研究概览
简要总结
This single-arm, open-label, multi-centre study will evaluate the efficacy and safety of MabThera/Rituxan (rituximab) in patients with follicular non-Hodgkin's lymphoma with minimal residual disease after autologous haematopoietic stem cell transplantation (bone marrow or peripheral blood). Two groups of patients will be considered for treatment. Group A: Patients with evaluable minimal tumor mass, Group B: Patients with complete response and abnormal B-cell lymphoma 2 (bcl2) status. Patients will receive MabThera/Rituxan 375 mg/m2 intravenously once every week. The anticipated time on study treatment is 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Adult patients, 18-75 years of age
- •Diagnosis of follicular non-Hodgkin's lymphoma (FNHL)
- •Previously treated with chemotherapy with autologous haemotopoietic stem cell transplantation (bone marrow or peripheral blood cells)
排除标准
- •Active viral hepatitis
- •Eastern Cooperative Oncology Group (ECOG) performance status >2
- •Patients not willing to sign informed consent form
研究组 & 干预措施
Single arm
干预措施: rituximab [MabThera/Rituxan] (Drug)
结局指标
主要结局
Normalization of B-cell lymphoma 2 levels
时间窗: Day 50
Treatment response rate according to World Health Organization criteria (Group A)
时间窗: Day 50
次要结局
- Safety: Incidence of adverse events(3 years)
- Progression-free survival(3 years)
- Duration of treatment response(3 years)