At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 75 enrolled
Drug / intervention
Ibrutinib 420 mg +1 moredrug
Likely dose
Ibrutinib 420 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Multicenter, Open Label Single Arm Phase IV Clinical Trial to Assess Safety of ImbruvicaTM (Ibrutinib Capsules 140 mg) in Indian Patients With Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy or Chronic Lymphocytic Leukemia With 17p Deletion
In Brief
A Phase 4 clinical trial evaluating Ibrutinib 420 mg and Ibrutinib 560 mg for Leukemia, Lymphocytic, Chronic, B-Cell and Lymphoma, Mantle-Cell. Completed, enrolled 75 participants across 10 sites.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIndia
Collaborators--
Timeline
Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedJun 2017
Enrollment StartJun 2019
Primary CompletionMay 2023
TodayJul 2026
First PostedJun 16, 2017
Enrollment StartJun 26, 2019
Primary CompletionMay 3, 2023
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 9.0 years ago
Interventions
Ibrutinib 420 mgdrug
Ibrutinib capsule administered orally at a dose of 420 mg for CLL participants.
Ibrutinib 560 mgdrug
Ibrutinib capsule administered orally at a dose of 560 mg for MCL participants.