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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

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

NCT03190330•Johnson & Johnson Private Limited

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 participating or planning to participate in any interventional drug trial during the course of this study

Locations (10)

Avron Hospitals Pvt. Ltd

Ahmedabad, India

Post Graduate Institute of Medical Education And Research PGIMER

Chandigarh, India

Basavatarakam Indo-American Hospital

Hyderabad, India

Bhagwan Mahaveer Cancer Hospital & Research Centre

Jaipur, India

Cytecare Hospitals Pvt. Ltd

Karnataka, India

Apollo Multispeciality Hospital Ltd

Kolkata, India

Tata Medical Center

Kolkata, India

Jawaharlal Institute of Postgraduate Medical Education and Research

Puducherry, India

Deenanath Mangeshkar Hospital and Research Centre

Pune, India

Noble Hospital Pvt Ltd

Pune, India

Key Dates

Start Date

June 26, 2019

Primary Completion Date

May 3, 2023

Completion Date

May 3, 2023

Last Updated

May 25, 2025

Enrollment

ACTUAL participants

Conditions

Leukemia, Lymphocytic, Chronic, B-CellLymphoma, Mantle-Cell

Interventions

Ibrutinib 420 mg

DRUG

Ibrutinib 560 mg

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Long-Term Safety of Pirtobrutinib in Participants With Previously Treated Types of Blood Cancers

Long-term Follow-up Study of Allogeneic Gamma Delta (γδ) CAR T Cells

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