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
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
2 other identifiers
interventional
75
1 country
10
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2019
Longer than P75 for phase_4
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2017
CompletedFirst Posted
Study publicly available on registry
June 16, 2017
CompletedStudy Start
First participant enrolled
June 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 3, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 3, 2023
CompletedResults Posted
Study results publicly available
May 21, 2024
CompletedMay 25, 2025
May 1, 2025
3.9 years
June 14, 2017
April 30, 2024
May 22, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
Day 1 up to 30 days after last dose of study drug (up to 13 months)
Study Arms (1)
Ibrutinib
EXPERIMENTALParticipants 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.
Interventions
Ibrutinib capsule administered orally at a dose of 420 mg for CLL participants.
Ibrutinib capsule administered orally at a dose of 560 mg for MCL participants.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Avron Hospitals Pvt. Ltd
Ahmedabad, 380013, India
Post Graduate Institute of Medical Education And Research PGIMER
Chandigarh, 160012, India
Basavatarakam Indo-American Hospital
Hyderabad, 500034, India
Bhagwan Mahaveer Cancer Hospital & Research Centre
Jaipur, 302017, India
Cytecare Hospitals Pvt. Ltd
Karnataka, 560064, India
Apollo Multispeciality Hospital Ltd
Kolkata, 700019, India
Tata Medical Center
Kolkata, 700156, India
Jawaharlal Institute of Postgraduate Medical Education and Research
Puducherry, 605008, India
Deenanath Mangeshkar Hospital and Research Centre
Pune, 411004, India
Noble Hospital Pvt Ltd
Pune, 411013, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr. Medical Advisor
- Organization
- Johnson & Johnson Private Limited
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Private Limited Clinical Trial
Johnson & Johnson Private Limited
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2017
First Posted
June 16, 2017
Study Start
June 26, 2019
Primary Completion
May 3, 2023
Study Completion
May 3, 2023
Last Updated
May 25, 2025
Results First Posted
May 21, 2024
Record last verified: 2025-05