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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-26

Study Completion Date

2023-05-03

Brief Summary

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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).

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Ibrutinib

Participants will receive ibrutinib 420 milligram (mg) (three 140 mg capsules) as a single daily dose for chronic lymphocytic leukemia (CLL) and 560 mg (four 140 mg capsules) as a single daily dose for mantle cell lymphoma (MCL) for up to 12 months or till disease progression, whichever is earlier.

Group Type EXPERIMENTAL

Ibrutinib 420 mg

Intervention Type DRUG

Ibrutinib capsule administered orally at a dose of 420 mg for CLL participants.

Ibrutinib 560 mg

Intervention Type DRUG

Ibrutinib capsule administered orally at a dose of 560 mg for MCL participants.

Interventions

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Ibrutinib 420 mg

Ibrutinib capsule administered orally at a dose of 420 mg for CLL participants.

Intervention Type DRUG

Ibrutinib 560 mg

Ibrutinib capsule administered orally at a dose of 560 mg for MCL participants.

Intervention Type DRUG

Other Intervention Names

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Imbruvica Imbruvica

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No