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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

NCT03190330 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-05-25

Study results available
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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

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.

Sponsors & Collaborators

  • Johnson & Johnson Private Limited

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Private Limited Clinical Trial · Johnson & Johnson Private Limited

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-26
Primary Completion
2023-05-03
Completion
2023-05-03
FDA Drug
Yes

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03190330 on ClinicalTrials.gov