Clinical Outcomes of CLL and MCL Patients Treated With Ibrutinib: An Observational Retrospective Medical Chart Review From India
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 8
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
The purpose of this study is to describe the effectiveness (overall response rate [ORR] and time to progression [TPP]) of Ibrutinib therapy in participants with chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) or Mantle Cell Lymphoma (MCL)
- •CLL or MCL participants being newly initiated on Imbruvica treatment (ibrutinib capsule 140 mg) based on independent clinical judgment of treating physicians
排除标准
- •Any contraindications to ibrutinib use according to the current version of the Prescribing information in India
研究组 & 干预措施
Participants with Chronic Lymphocytic Leukemia (CLL)
This study will collect retrospective data on effectiveness and outcome parameters for participants of CLL being managed with ibrutinib in the clinical practice. The primary data source for this observational study will be the medical records of each enrolled participant.
干预措施: Ibrutinib (Drug)
Participants with Mantle Cell Lymphoma (MCL)
This study will collect retrospective data on effectiveness and outcome parameters for participants of MCL being managed with ibrutinib in the clinical practice. The primary data source for this observational study will be the medical records of each enrolled participant.
干预措施: Ibrutinib (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: Up to 14 months
ORR is defined as achievement of complete response (CR) or partial response (PR) per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 guidelines for Chronic Lymphocytic Leukemia (CLL) and Mantle-cell Lymphoma (MCL). CR is defined as resolution of enlarged lymph nodes, spleen and liver; normalization of blood counts (neutrophils, hemoglobin, platelets); no residual CLL/MCL detectable in the bone marrow. PR is defined as 50 percent (%) or more reduction in size of enlarged lymph nodes, liver or spleen; 50% or more improvement of blood counts; 50% or more reduction in the blood lymphocyte count.
Time to Progression (TTP)
时间窗: Up to 14 months
Time to progression will be reported for the observed participants receiving ibrutinib. TTP is defined as the period from study entry until objective disease progression (time from the date of randomization until disease progression or death due to progression, whichever occur first).
Percentage of Participants with Complete Response (CR)
时间窗: Up to 14 months
Percentage of participants with CR will be reported. CR is defined as resolution of enlarged lymph nodes, spleen and liver; normalization of blood counts (neutrophils, hemoglobin, platelets); no residual CLL/MCL detectable in the bone marrow.
Percentage of Participants with Partial Response (PR)
时间窗: Up to 14 months
Percentage of participants with PR will be reported. PR is defined as 50 percent (%) or more reduction in size of enlarged lymph nodes, liver or spleen; 50% or more improvement of blood counts; 50% or more reduction in the blood lymphocyte count.
Percentage of Participants with Stable Disease (SD)
时间窗: Up to 14 months
Percentage of participants with SD will be reported. Participants who have not achieved a CR or a PR, and who have not exhibited progressive disease will be considered to have stable disease.
Percentage of Participants with Progressive Disease (PD)
时间窗: Up to 14 months
Percentage of participants with PD will be reported. PD is defined as 50% or more increase in lymph nodes or the appearance of new enlarged lymph nodes; 50% or more increase in the size of the spleen or liver; 50% or more increase in blood lymphocyte count.
次要结局
- Median time to Response with Ibrutinib(Up to 14 months)
- Change from Baseline in Hemoglobin Levels(Baseline up to 14 months)
- Change from Baseline in Platelet Counts(Baseline up to 14 months)
- Number of Participants with Response to Ibrutinib by Prior Lines of Therapy(Up to 14 months)
- Number of Participants with Hematological and Non-hematological Adverse Drug Reactions (ADR)(Up to 14 months)