The primary purpose of this study is to evaluate the post-marketingsafety of ImbruvicaTM (ibrutinib capsule 140 milligram [mg]) underactual conditions of use, and to understand the incidence ofadverse events (AEs) (serious and non-serious AEs).
- Conditions
- Health Condition 1: C911- Chronic lymphocytic leukemia of B-cell typeHealth Condition 2: C831- Mantle cell lymphoma
- Registration Number
- CTRI/2019/04/018710
- Lead Sponsor
- Johnson and Johnson Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 75
1. Chronic lymphocytic leukemia (CLL) or mantle cell lymphoma (MCL) participants being newly initiated on Imbruvica treatment (ibrutinib capsule 140 milligram [mg]) based on independent clinical judgment of treating physicians as per locally approved prescribing information
2. Must give a written informed consent indicating that they understand the purpose and are willing to participate in the study and allowing data collection and source data verification in accordance with regulatory requirements
1. Participants who are not eligible to receive Imbruvica as per the locally approved prescribing information
2.Participants participating or planning to participate in any interventional drug trial during the course of this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of Participants With Adverse Events as a Measure of Safety and TolerabilityTimepoint: Up to 13 Months
- Secondary Outcome Measures
Name Time Method oneTimepoint: None