Phase 4
N=75
A Study to Assess Safety of ImbruvicaTM in Indian Participants With Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy or Chronic Lymphocytic Leukemia With 17p Deletion
Leukemia, Lymphocytic, Chronic, B-Cell · Lymphoma, Mantle-Cell
Bottom Line
View on ClinicalTrials.gov: NCT03190330 ↗Enrolled (actual)
75
Serious AEs
30.7%
Results posted
May 2024
Primary outcome: Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) — 62 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ibrutinib 420 mg (Drug); Ibrutinib 560 mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Private Limited
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
62 | — |
| PRIMARY Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) |
23 | — |
Summary
The primary purpose of this study is to evaluate the post-marketing safety of ImbruvicaTM (ibrutinib capsule 140 milligram [mg]) under actual conditions of use, and to understand the incidence of adverse events (AEs) (serious and non-serious AEs).
Eligibility Criteria
Inclusion Criteria
- 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
- 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
Exclusion Criteria
- Participants who are not eligible to receive Imbruvica as per the locally approved prescribing information
- Participants participating or planning to participate in any interventional drug trial during the course of this study
Data sourced from ClinicalTrials.gov (NCT03190330). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.