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).

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

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/04/018710

Enrollment

Registered

2019-04-24

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C911- Chronic lymphocytic leukemia of B-cell type Health Condition 2: C831- Mantle cell lymphoma

Interventions

Intervention1: Ibrutinib: Participants will receive ibrutinib 420milligram (mg) (three 140 mg capsules) as a single daily dose for chronic lymphocytic leukaemia (CLL) and 560 mg (four 140 mg capsules)

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 2. 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

Exclusion criteria: 1. Participants who are not eligible to receive Imbruvica as per the locally approved prescribing information 2.Participants participating or planning to participate in any interventional drug trial during the course of this study

Design outcomes

Secondary

Measure	Time frame
NoneTimepoint: None	—

Primary

Measure	Time frame
Number of Participants With Adverse Events as a Measure of Safety and TolerabilityTimepoint: Up to 13 Months	—

Countries

India

Contacts

Public ContactDr Jitendra Dixit

Johnson & Johnson Private Limited

JDixit@ITS.JNJ.COM

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026