Bendamustine and Temsirolimus in Patients With Relapsed or Refractory Mantle Cell Non-Hodgkin's Lymphoma (NHL)
2011年3月15日 更新者:Charite University, Berlin, Germany
Phase I/II Study With Bendamustine and Temsirolimus in Patients With Relapsed or Refractory Mantle Cell Non-hodgkin's Lymphoma (NHL) Not Eligible for High Dose Chemotherapy and Autologous/Allogeneic Stem Cell Transplantation
The purpose of this study is to assess the safety, tolerability and activity of the combination of bendamustine and rituximab in patients with relapsed/refractory mantle cell lymphoma who are not eligible for high dose chemotherapy and autologous/allogeneic stem cell transplantation.
研究概览
研究类型
介入性
注册 (预期的)
20
阶段
- 阶段2
- 阶段1
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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Berlin、德国、10117
- Dept. of Hematology and Oncology, Charité, Campus Charité Mitte
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Berlin、德国、12203
- Dept. of Hematology and Oncology, Charité, Campus Benjamin Franklin
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Berlin、德国、13353
- Dept. of Hematology and Oncology, Charité, Campus Virchow Klinikum Charité
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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:
- Age 18 years or older
- Mantle Cell Lymphoma according to REAL/WHO classification
- First or second relapse or alternatively progression during therapy. Previous use of Bendamustine is permitted, if the patient has reached at least partial remission and progression occured more than 6 months after therapy. Previous high dose chemotherapy with auto-SCT is permitted, if the patient has reached at least partial remission and progression occured more than 12 months after therapy.
- Patients must not be eligible for high dose chemotherapy with auto-SCT or allo-SCT.
- Adequate bone marrow function (hemoglobin > 9g/dl, platelet count >100/nL, absolute neutrophil count >1,5 /nL)
- WHO/ECOG Performance Status 0-2
- Measurable disease (two perpendicular diameters by either physical or radiological examination)
- Life expectancy ≥ 3 weeks
- Written informed consent
Exclusion Criteria:
- Prior treatment with any m-TOR Inhibitor
- Unstable or severe uncontrolled medical condition (e.g. severe congestive heart failure, myocardial infarction within the past 6 months, severe, uncontrolled arterial hypertension, renal insufficiency requiring hemodialysis, severe pulmonary disease, severe diabetes)
- Abnormal liver function: transaminases or total bilirubin > 2 x upper limit of normal (ULN)
- Abnormal renal function: serum creatinine > 2 x upper limit of normal
- Previous malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix.
- Concurrent treatment with strong inhibitors of CYP3A4 and/or inducers of CYP3A4
- Pregnant or breastfeeding women (negative pregnancy test not older than 7 days is required for women of fertile age). Men and women of child-bearing potential must agree to use adequate contraception (i.e. failure rate < 1% p.a. )
- Major surgery within 4 weeks before study entry; minor procedures (e.g. Implantation i.v. port catheter, Lymphnode biopsy) within 1 week before study entry
- Previous therapy with any investigational agents within 28 days before study entry
- Concomitant immunotherapy (e.g. Rituximab) or Chemotherapy other than Bendamustine. Use of systemic steroids should be documented and the Principal Investigator be informed.
- Central nervous system (CNS) lymphomatous involvement
- HIV positivity
- Current or chronic hepatitis B or hepatitis C infection
- Severe psychiatric illness or Individuals that are placed in an institution due to a magisterial or judiciary command.
- Inability to comply with study requirements
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:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
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 |
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Phase I: Dose-finding
大体时间:6 months
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Is the combination of temsirolimus alongside with bendamustine at the suggested dose feasible or are dose reductions necessary.
Number of dose reductions or delays of therapy due to hematologic toxicities (CTCAE) or other adverse events according to protocoll.
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6 months
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Phase II: Response Rate (Overall response rate, complete and partial response)
大体时间:6 months
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What is the response rate of a therapy with temsirolimus and bendamustine.
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6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Progression free survival
大体时间:2 years
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This is defined as the period of time between the admission into the clinical trial and the progression of the lymphoma or death of any kind.
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2 years
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Safety and Tolerability of Temsirolimus and Bendamustine Combination Therapy
大体时间:2 years
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Detection of overall toxicity, serious adverse events (SAE), suspected unexpected serious adverse reactions (SUSAR) during treatment with temsirolimus and bendamustine.
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2 years
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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。
调查人员
- 首席研究员:Christian Scholz, PD Dr.、Charite University, Berlin, Germany
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
2010年5月1日
初级完成 (预期的)
2012年4月1日
研究完成 (预期的)
2014年4月1日
研究注册日期
首次提交
2010年7月14日
首先提交符合 QC 标准的
2010年7月26日
首次发布 (估计)
2010年7月27日
研究记录更新
最后更新发布 (估计)
2011年3月16日
上次提交的符合 QC 标准的更新
2011年3月15日
最后验证
2010年6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.