Genes in Predicting Outcome of Patients With DLBCL Treated With Rituximab and Combination Chemotherapy (R-CHOP) (R-CHOP)
2017年6月2日 更新者:Izidore Lossos、University of Miami
Phase II Study to Establish Gene Expression Models Predicting Survival of Diffuse Large B-Cell Lymphoma Patients Treated With R-CHOP
The investigators hypothesize that survival of newly diagnosed DLBCL (diffuse large B-cell lymphoma) patients treated with R-CHOP can be predicted by RNA or protein gene expression or by presence of biomarkers associated with the anti-tumor effects of Rituximab.
研究概览
详细说明
In this phase II multi-institutional trial, the investigators will identify genes associated with either good or bad outcome in DLBCL patients treated with R-CHOP, will construct a robust predictive models based on RNA extracted from or paraffin specimens as well on immunohistochemistry and will examine the predictive power of new biomarkers associated with the anti-tumor effects of rituximab.
The acquisition of fixed tissue as a component of this uniformly treated prospective study will also afford future studies with this informative dataset.
研究类型
介入性
注册 (实际的)
57
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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California
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Stanford、California、美国、94305
- Stanford University
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Florida
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Miami、Florida、美国、33136
- University of Miami
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New York
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Rochester、New York、美国、14642
- University of Rochester Medical Center - Wilmot Cancer Institute
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Ohio
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Cleveland、Ohio、美国、44195
- Cleveland Clinic
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Tennessee
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Nashville、Tennessee、美国、37232
- Vanderbilt-Ingram Cancer 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 至 120年 (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:
- 1. Diagnosis of diffuse large B-cell lymphoma, CD20-positive, according to the World Health Organization Classification, stages II-IV or limited stage I disease that is bulky (more than 10 cm) or with International Prognostic Index (IPI) score > 1.
- 2. Patients must not have had prior chemotherapy, radiotherapy or immunotherapy. A short course (< 2 weeks) of corticosteroids is allowed.
- 3. Adequate paraffin-embedded tumor specimen must be available for gene expression analysis and immunohistochemistry prior to initiation of therapy. (If the specimen is deemed inadequate, the subject can be retroactively screen failed, as this does not change the treatment regimen).
- 4. Baseline measurements and evaluation must be obtained within 4 weeks before first treatment.
- 5. Age >18 years.
- 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-3.
7. Adequate organ function:
- White Blood Cells count (WBC) >2500/µL
- Absolute Neutrophil Count (ANC) > 1000/µL (unless due to disease in marrow)
- platelet count >100,000/µL (unless due to disease in marrow)
- creatinine < 2.0 mg/dL,
- bilirubin < 1.5 mg/dL (may be 1.5-3.0 mg/dl if due to liver involvement by lymphoma)
- Serum Glutamic Oxaloacetic Transaminase (SGOT)/ Serum Glutamic Pyruvic Transaminase (SGPT) <3 x upper limit of normal.
- 8. Female patients must not be pregnant or breast feeding.
- 9. Women of childbearing potential and men must be strongly advised to use an accepted and effective method of contraception.
- 10. Patients must have left ventricular ejection fraction of >45%.
- 11. Provision of written informed consent.
Exclusion Criteria:
- 1. Patients with a second malignancy other than basal cell carcinoma of the skin or in situ carcinoma of the cervix unless the tumor was treated with curative intent at least two years previously; and; the patient continue to be free of evidence of recurrence.
- 2. Patients with HIV infection as these patients are managed on dedicated protocols.
- 3. Patients with active central nervous system (CNS) lymphoma.
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:R-CHOP
Patients will receive R-CHOP for 6 to 8 cycles:
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Rituximab 375 mg/m2 on day 1 for 6 to 8 cycles
其他名称:
Cyclophosphamide 750 mg/m2 IV on day 1 for 6 to 8 cycles
其他名称:
Doxorubicin 50 mg/m2 on day 1 for 6 to 8 cycles
其他名称:
Prednisone 40 mg/m2 orally days 1-5, repeated every 21 days for 6 to 8 cycles.
其他名称:
Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1 for 6 to 8 cycles
其他名称:
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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 |
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Determination of a List of Genes and Construction of Survival Prediction Models That Will Predict Overall Survival at 30 Months in DLBCL Patients Receiving R-CHOP Therapy.
大体时间:30 months
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The investigators aim to determine a list of genes and construct survival prediction model(s) that will predict the overall survival at 30 months in DLBCL patients prospectively treated with R-CHOP chemotherapy.
Overall survival time will be calculated from the date of the diagnosis until death or last follow-up examination.
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30 months
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Usefulness of Biomarkers Associated With Anti-Tumor Effects of Rituximab in Predicting Overall Survival in DLBCL Patients Receiving R-CHOP Therapy
大体时间:24 Months
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The investigators aim to determine the usefulness of biomarkers associated with the antitumor effects of rituximab (e.g.
immunoglobulin GFc receptor genotypes, CD20 protein expression and gene expression profiles) to predict overall survival of DLBCL patients treated with R-CHOP therapy and followed for at least 24 months or until death.
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24 Months
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Comparison of the Ability of Constructed Survival Models to Predict Overall Survival in DLBCL Patients Receiving R-CHOP Therapy
大体时间:2 Years
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The investigators will compare the ability of constructed survival models to predict survival in DLBCL patients receiving R-CHOP therapy
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2 Years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Determination of the Ability of Models and/or Biomarkers Associated With Anti-Tumor Effects of Rituximab to Predict 24-month Time to Treatment Failure in DLBCL Patients Receiving R-CHOP Therapy
大体时间:24 Months
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The investigators aim to determine the ability of the models and/or biomarkers associated with the anti-tumor effects of rituximab to predict 24-month time to treatment failure, defined as disease progression, death or initiation of new treatment.
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24 Months
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Overall Response Rate of Study Participants at the End of Protocol Therapy
大体时间:Up to 8 cycles, about 24 weeks
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Rate of participants achieving complete response (CR), complete response/unconfirmed (CRu) partial response (PR) according to Non-Hodgkin's Lymphoma response criteria.
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Up to 8 cycles, about 24 weeks
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Number of Participants From Whom Fixed Tissue Samples Were Collected for Future Studies.
大体时间:Baseline
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Number of participants from whom paraffin-embedded DLBCL tissue samples were collected for future studies.
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Baseline
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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
- 学习椅:Izidore S. Lossos, MD、University of Miami
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 (实际的)
2007年4月24日
初级完成 (实际的)
2016年5月1日
研究完成 (实际的)
2016年5月1日
研究注册日期
首次提交
2007年3月20日
首先提交符合 QC 标准的
2007年3月20日
首次发布 (估计)
2007年3月22日
研究记录更新
最后更新发布 (实际的)
2017年6月23日
上次提交的符合 QC 标准的更新
2017年6月2日
最后验证
2017年5月1日
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- 20061138
- SCCC-2006069 (其他标识符:University of Miami Sylvester Comprehensive Cancer Center)
- WIRB-20070073 (其他标识符:Western Institutional Review Board)
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.
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