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

Phase 4CompletedNCT03190330

Johnson & Johnson Private Limited75 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

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

Interventions

Ibrutinib 420 mg

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Any AE occurred at or after the initial administration of study drug up to maximum of 30 days after last dose was considered as treatment emergent.

Time frame: Day 1 up to 30 days after last dose of study drug (up to 13 months)

Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)

An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was an AE which resulted in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Any AE occurred at or after the initial administration of study drug up to maximum of 30 days after last dose was considered as treatment emergent.

Time frame: Day 1 up to 30 days after last dose of study drug (up to 13 months)