Clinical Response in Patients With Relapsed Centroblastic Centrocytic Non-Hodgkin's Lymphoma After Treatment With Anti-CD20 Antibody IDEC C2B8 (MabThera)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 主要终点
- Percentage of Participants With a Complete Remission (CR) or Partial Remission (PR)
研究概览
简要总结
This study will evaluate the efficacy and safety of MabThera/Rituxan in patients with relapsed low-grade centroblastic centrocytic non-Hodgkin's lymphoma. Patients will receive once-weekly intravenous MabThera/Rituxan for 4 weeks; responding patients will be treated a second time in case of relapse (defined as progression after complete or partial response). The anticipated time on study treatment is <3 months.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients >= 18 years of age;
- •centrocytic centroblastic non-Hodgkin's lymphoma stage III-IV;
- •relapse after chemotherapy (with or without interferon maintenance therapy).
排除标准
- •primary refractory lymphomas;
- •more than 3 relapses of centroblastic centrocytic non-Hodgkin's lymphoma;
- •clinically significant cardiac disease.
研究组 & 干预措施
MabThera/Rituxan
干预措施: rituximab [MabThera/Rituxan] (Drug)
结局指标
主要结局
Percentage of Participants With a Complete Remission (CR) or Partial Remission (PR)
时间窗: Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
Percentage of participants with a CR, PR at the end of the first cycle of treatment (Week 4). CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes \>1.500/ microliter (µL), hemoglobin (Hb) \>12 grams per deciliter (g/dL), and platelets \>100,000/µL. PR was defined as a less than (\<) 50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts.
次要结局
- Time to Best Response(Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months))
- Time to Progression(Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months))
- Overall Survival (OS)(Enrollment into study until end of follow-up or death. The median length of follow-up was 6.6 months (range: 0-97.8 months))
- Number of Participants With a Clinical Response to Re-Treatment(First application in the second treatment cycle until progression of disease. The median length of follow-up was 4.6 months (range: 0.5-20.6 months).)
- Number of Participants With a Clinical Response(Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months))
- Duration of Remission(Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months))