A Study of Obinutuzumab Evaluating Efficacy, Safety and Cost of Disease Management in Participants With Chronic Lymphocytic Leukemia and Comorbidities
2022年6月27日 更新者：Hoffmann-La Roche
A Multicenter, Single Arm, Non-Interventional, Observational Study of Obinutuzumab to Evaluate Efficacy, Safety and Cost of Disease Management in Patients With Chronic Lymphocytic Leukemia and Comorbidities in Greece
This multicenter, single arm, non-interventional, observational study will evaluate the efficacy and safety of obinutuzumab in daily clinical practice in participants with chronic lymphocytic leukemia (CLL).
The study will also assess cost of disease management.
The total length of the study is 42 months.
研究概览
研究类型
观察性的
注册 (实际的)
50
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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Alexandroup、希腊、068100
- University General Hospital of Alexandroupolis; Haemotology
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Athens、希腊、124 62
- Attiko Hospital; Haematology Clinic
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Athens、希腊、115 27
- Laiko General Hospital; Hematology Clinic
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Athens、希腊、115 27
- Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine
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Athens、希腊、11527
- General Hospital G. Gennimatas; Hematology Dept.
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Heraklion、希腊、711 10
- Periph. University General Hospital of Heraklion; Hematology
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Larissa、希腊、411100
- University Hospital of Larissa; Hematology Dept.
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Patra、希腊、26504
- University General Hospital of Patra; Internal Medicine Clinic - Hematology Department
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Peiraias、希腊、18537
- Metaxa Hospital; Hematology Clinic
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Thessaloniki、希腊、54636
- AXEPA Pathology Section; A Pathology Clinic
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Thessaloniki、希腊、570 10
- General Hospital G. Papanikolaou; Hematology, BMT Unit
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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
取样方法
非概率样本
研究人群
Participants receiving obinutuzumab for CLL and comorbidities
描述
Inclusion Criteria:
- Participants with untreated CLL and comorbidities, for which the physician has already decided to use obinutuzumab in association with chlorambucil
Exclusion Criteria:
- Participation in another clinical trial during the study
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Obinutuzumab
Participants will receive obinutuzumab as per Summary of Product Characteristics in daily practice along with chlorambucil for 24 months.
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Participants will receive chlorambucil as per summary of product characteristics in daily practice.
Protocol does not specify any dosage.
Participants will receive obinutuzumab as per summary of product characteristics in daily practice.
Protocol does not specify any dosage.
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 |
大体时间 |
|---|---|
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Progression Free Survival (PFS)\n
大体时间：From screening every 6 months to Month 18 until disease progression (up to 24 months)
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From screening every 6 months to Month 18 until disease progression (up to 24 months)
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Overall Survival (OS)
大体时间：From screening every 6 months to Month 18 until disease progression (up to 24 months)
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From screening every 6 months to Month 18 until disease progression (up to 24 months)
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Percentage of Participants With Overall Response as Assessed by Investigator
大体时间：From screening every 6 months to Month 18 until disease progression (up to 24 months)
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From screening every 6 months to Month 18 until disease progression (up to 24 months)
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Time to Response
大体时间：From screening every 6 months to Month 18 until disease progression (up to 24 months)
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From screening every 6 months to Month 18 until disease progression (up to 24 months)
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Percentage of Participants With Best Overall Response as Assessed by Investigator
大体时间：From screening every 6 months to Month 18 until disease progression (up to 24 months)
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From screening every 6 months to Month 18 until disease progression (up to 24 months)
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Time to Next Treatment, Defined as the Time Between the Date of Enrollment and First Intake of New Anti-Leukemic Therapy
大体时间：Baseline up to 24 months
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Baseline up to 24 months
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Duration of Response
大体时间：From screening every 6 months to Month 18 until disease progression (up to 24 months)
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From screening every 6 months to Month 18 until disease progression (up to 24 months)
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Percentage of Participants With Protocol Defined Adverse Events of Special Interest
大体时间：Baseline up to 24 months
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Baseline up to 24 months
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Percentage of Participants With Protocol Defined Adverse Events of Particular Interest
大体时间：Baseline up to 24 months
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Baseline up to 24 months
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Percentage of Participants With Dose Delays/Discontinuations
大体时间：Baseline up to 24 months
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Baseline up to 24 months
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Percentage of Participants With Hematological Toxicities
大体时间：Baseline up to 24 Months
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Baseline up to 24 Months
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Percentage of Participants With Non-hematological Toxicities
大体时间：Baseline up to 24 months
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Baseline up to 24 months
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Number of Hospital Admissions
大体时间：Baseline up to 24 months
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Baseline up to 24 months
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Number of Physician Visits
大体时间：Baseline up to 24 months
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Baseline up to 24 months
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Number of Diagnostic and Lab Exams
大体时间：Baseline up to 24 months
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Baseline up to 24 months
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Number of Medical Procedures (Blood Transfusions, Bone Marrow, or Stem Cell Transplantation)
大体时间：Baseline up to 24 months
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Baseline up to 24 months
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Costs of Treatment With Obinutuzumab
大体时间：Baseline up to 24 months
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Baseline up to 24 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 (实际的)
2016年11月23日
初级完成 (实际的)
2021年6月8日
研究完成 (实际的)
2021年6月8日
研究注册日期
首次提交
2016年9月23日
首先提交符合 QC 标准的
2016年9月23日
首次发布 (估计)
2016年9月26日
研究记录更新
最后更新发布 (实际的)
2022年6月28日
上次提交的符合 QC 标准的更新
2022年6月27日
最后验证
2022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.
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