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 4

Completed

Brief 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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Ibrutinib	Ibrutinib 560 mg	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.
Ibrutinib	Ibrutinib 420 mg	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	Day 1 up to 30 days after last dose of study drug (up to 13 months)	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.
Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)	Day 1 up to 30 days after last dose of study drug (up to 13 months)	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.

Secondary Outcome Measures

Name	Time	Method

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
Apollo Multispeciality Hospital Ltd
🇮🇳
Kolkata, India
Tata Medical Center
🇮🇳
Kolkata, India
Jawaharlal Institute of Postgraduate Medical Education and Research
🇮🇳
Pondicherry, India
Cytecare Hospitals Pvt. Ltd
🇮🇳
Karnataka, India
Deenanath Mangeshkar Hospital and Research Centre
🇮🇳
Pune, India
Noble Hospital Pvt Ltd
🇮🇳
Pune, India