A Phase II Study of VELCADE (Bortezomib) in Combination With Bendamustine and Rituximab in Subjects With Relapsed or Refractory Follicular Lymphoma (VERTICAL)
2012年1月11日 更新者：Millennium Pharmaceuticals, Inc.
This is a phase 2, single-arm, open label, multicenter study evaluating the efficacy and safety of the combination of VELCADE, bendamustine, and rituximab in subjects with relapsed or refractory follicular lymphoma, who have received 4 or more doses of rituximab.
Subjects may be sensitive or refractory to prior therapies, including rituximab.
研究概览
研究类型
介入性
注册 (实际的)
73
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
-
-
District of Columbia
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Washington、District of Columbia、美国、20057
- Georgetown University Medical Center
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North Dakota
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Bismarck、North Dakota、美国、58501
- MidDakota Clinic - Cancer Treatment and Research Center
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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:
- Male or female subject 18 years of age or older
- Pathological diagnosis of follicular lymphoma (any grade)
- Documented relapse or progression following prior antineoplastic therapy
- Have received 4 or more prior doses of rituximab
- At least 1 measurable tumor mass (>1.5 cm in the long axis and >1.0 cm in the short axis that has not been previously irradiated, or has grown since previous irradiation
- No clinically significant central nervous system lymphoma
- Karnofsky performance status (KPS) ≥50 (equivalent to Eastern Cooperative Group Oncology Group [ECOG] status ≤2
Exclusion Criteria:
- Diagnosed or treated for a malignancy other than non-Hodgkin's lymphoma (NHL) within 2 years of first dose, or who were previously diagnosed with a malignancy other than NHL and have any radiographic or biochemical marker evidence of malignancy. Subjects with prostate cancer who were treated with definitive radiotherapy and have a serum prostate-specific antigen (PSA) <1 ng/mL are not excluded. Subjects are also not excluded if they have had basal cell or squamous cell carcinoma of the skin that was completely resected, or any in situ malignancy that was adequately treated.
- Prior treatment with VELCADE® or bendamustine
- Antineoplastic (including unconjugated therapeutic antibodies and toxin immunoconjugates), experimental, or radiation therapy within 3 weeks before Day 1 of Cycle 1
- Nitrosoureas within 6 weeks before Day 1 of Cycle 1
- Radioimmunoconjugates within 10 weeks before Day 1 of Cycle 1
- Autologous stem cell transplant within 3 months before Day 1 of Cycle 1, or prior allogeneic stem cell transplant at any time
- Major surgery within 2 weeks before Day 1 of Cycle 1
- Platelet transfusion within 7 days of Day 1 of Cycle 1 (applies to subjects enrolled in the dose escalation phase only. This does not apply to subjects enrolled in phase 2 of the study).
- Ongoing therapy with corticosteroids. Prednisone ≤15 mg per day or its equivalent is allowed.
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）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：1
This is a phase 2, single-arm, open label, multicenter study evaluating the efficacy and safety of the combination of VELCADE, bendamustine, and rituximab in subjects with relapsed or refractory follicular lymphoma, who have received 4 or more doses of rituximab.
Subjects may be sensitive or refractory to prior therapies, including rituximab.
|
VELCADE administered as a 3- to 5-second intravenous (IV) bolus prior to Bendamustine and Rituximab on Days 1,8,15 and 22 of each cycle.
Bendamustine administered IV over 30-60 minutes after VELCADE on Days 1 and 2 of each cycle
Rituximab administered by IV infusion after VELCADE and Bendamustine on Days 1, 8, 15 and 22 of Cycle 1, and on Day 1 of Cycles 2, 3, 4 and 5
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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 |
|---|---|---|
|
Number of Participants With Complete Response
大体时间：12 weeks after the last subject completes their end of treatment visit.
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Response is assessed by investigator according to International Working Group (IWG) criteria.
Complete response requires disappearance of all evidence of disease.
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12 weeks after the last subject completes their end of treatment visit.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants With Overall Response (Complete and Partial Response)
大体时间：12 weeks after the last subject completes their end of treatment visit
|
Response is assessed by investigator according to International Working Group (IWG) criteria.
Complete response requires disappearance of all evidence of disease.
Partial response requires regression of measurable disease and no new sites.
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12 weeks after the last subject completes their end of treatment visit
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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
2008年2月1日
初级完成 (实际的)
2010年5月1日
研究完成 (实际的)
2010年5月1日
研究注册日期
首次提交
2008年3月11日
首先提交符合 QC 标准的
2008年3月13日
首次发布 (估计)
2008年3月14日
研究记录更新
最后更新发布 (估计)
2012年1月13日
上次提交的符合 QC 标准的更新
2012年1月11日
最后验证
2012年1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.