NCT03190330

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Johnson & Johnson Private Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Leukemia, Lymphocytic, Chronic, B-Cell
• Lymphoma, Mantle-Cell

Interventions

Type	Name	Description
DRUG	Ibrutinib 420 mg	Ibrutinib capsule administered orally at a dose of 420 mg for CLL participants.
DRUG	Ibrutinib 560 mg	Ibrutinib capsule administered orally at a dose of 560 mg for MCL participants.

Timeline

• Start date: 2019-06-26
• Primary completion: 2023-05-03
• Completion: 2023-05-03
• First posted: 2017-06-16
• Last updated: 2025-05-25
• Results posted: 2024-05-21

Locations

10 sites across 1 country: India

Regulatory

• FDA-regulated drug study