A Study of MabThera/Rituxan (Rituximab) in Patients With Relapsed Centroblastic Centrocytic Non-Hodgkin's Lymphoma
2014年11月17日 更新者：Hoffmann-La Roche
Clinical Response in Patients With Relapsed Centroblastic Centrocytic Non-Hodgkin's Lymphoma After Treatment With Anti-CD20 Antibody IDEC C2B8 (MabThera)
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.
研究概览
研究类型
介入性
注册 (实际的)
38
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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-
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Erlangen、德国、91054
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Grenzach-wyhlen、德国、79639
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Göttingen、德国、37075
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Hannover、德国、30625
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Homburg/saar、德国、66424
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Köln、德国、50924
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Muenchen、德国、80336
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Muenchen、德国、81377
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Muenster、德国、48129
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Stuttgart、德国、70376
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Tübingen、德国、72076
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- adult patients >= 18 years of age;
- centrocytic centroblastic non-Hodgkin's lymphoma stage III-IV;
- relapse after chemotherapy (with or without interferon maintenance therapy).
Exclusion Criteria:
- primary refractory lymphomas;
- more than 3 relapses of centroblastic centrocytic non-Hodgkin's lymphoma;
- clinically significant cardiac disease.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：美罗华/Rituxan
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375 mg/m2 iv weekly for 4 weeks; for responders to first course of therapy a second course is possible after relapse
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of Participants With a Complete Remission (CR) or Partial Remission (PR)
大体时间：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.
|
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)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants With a Clinical Response
大体时间：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)
|
Clinical response was defined as the best response after the first 4 weeks of treatment cycle by the following categories: CR, PR, minor response (MR), stable disease (SD), and progressive disease (PD).
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/μL, Hb >12 g/dL, and platelets >100,000/μL.
PR was defined as <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.
MR was defined as tumor regression ≥25% and <50%.
SD was defined as tumor regression <25%, no new manifestations, and progression ≤25%.
PD was defined as no new lymphoma associated symptoms or an increase in the size of manifestations by more than 25%.
|
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)
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Time to Best Response
大体时间：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)
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The median time, in months, from start of the treatment (first application) until best response (PR or CR).
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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)
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Duration of Remission
大体时间：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)
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Median time, in months, between the documentation of CR or PR and PD in clinical responders.
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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)
|
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Time to Progression
大体时间：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)
|
The median time, in months, from the start of treatment (first application) until detection of PD.
|
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)
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Overall Survival (OS)
大体时间：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)
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OS was defined as the time, in months, between enrollment into the study and death, due to any cause.
Participants who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive.
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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)
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Number of Participants With a Clinical Response to Re-Treatment
大体时间：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).
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Clinical response was defined as the best response after the second 4 weeks of treatment cycle by the following categories: CR, PR, MR, SD, and PD.
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/μL, Hb >12 g/dL, and platelets >100,000/μL.
PR was defined as <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.
MR was defined as tumor regression ≥25% and <50%.
SD was defined as tumor regression <25%, no new manifestations, and progression ≤25%.
PD was defined as no new lymphoma associated symptoms or an increase in the size of manifestations by more than 25%.
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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).
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
1997年1月1日
初级完成 (实际的)
2008年2月1日
研究完成 (实际的)
2008年2月1日
研究注册日期
首次提交
2013年11月25日
首先提交符合 QC 标准的
2013年11月25日
首次发布 (估计)
2013年12月2日
研究记录更新
最后更新发布 (估计)
2014年12月3日
上次提交的符合 QC 标准的更新
2014年11月17日
最后验证
2014年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.