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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

CompletedPhase 4

Sponsor: Johnson & Johnson Private Limited

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

Interventions: Ibrutinib 420 mg, Ibrutinib 560 mg

Countries: India

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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)

Ahmedabad, India
Chandigarh, India
Hyderabad, India
Jaipur, India
Karnataka, India
Kolkata, India
Kolkata, India
Puducherry, India
Pune, India
Pune, India