Back to resultsA 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
Primary Purpose
Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Mantle-Cell
Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Ibrutinib 420 mg
Ibrutinib 560 mg
Sponsored by
About this trial
This is an interventional other trial for Leukemia, Lymphocytic, Chronic, B-Cell
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
Sites / Locations
- Avron Hospitals Pvt. Ltd
- Post Graduate Institute of Medical Education & Research (PGIMER)
- Basavatarakam Indo-American Hospital
- Bhagwan Mahaveer Cancer Hospital & Research Centre
- Cytecare Hospitals Pvt. Ltd
- Apollo Multispeciality Hospital Ltd
- Tata Medical Center
- Jawaharlal Institute of Postgraduate Medical Education and Research
- Deenanath Mangeshkar Hospital and Research Centre
- Noble Hospital Pvt Ltd
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ibrutinib
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Secondary Outcome Measures
Full Information
NCT ID
NCT03190330
First Posted
June 14, 2017
Last Updated
August 16, 2023
Sponsor
Johnson & Johnson Private Limited
1. Study Identification
Unique Protocol Identification Number
NCT03190330
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 26, 2019 (Actual)
Primary Completion Date
May 3, 2023 (Actual)
Study Completion Date
May 3, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Private Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Mantle-Cell
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ibrutinib
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ibrutinib 420 mg
Other Intervention Name(s)
Imbruvica
Intervention Description
Ibrutinib capsule administered orally at a dose of 420 mg for CLL participants.
Intervention Type
Drug
Intervention Name(s)
Ibrutinib 560 mg
Other Intervention Name(s)
Imbruvica
Intervention Description
Ibrutinib capsule administered orally at a dose of 560 mg for MCL participants.
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Description
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Time Frame
Up to 13 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Private Limited Clinical Trial
Organizational Affiliation
Johnson & Johnson Private Limited
Official's Role
Study Director
Facility Information:
Facility Name
Avron Hospitals Pvt. Ltd
City
Ahmedabad
ZIP/Postal Code
380013
Country
India
Facility Name
Post Graduate Institute of Medical Education & Research (PGIMER)
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Facility Name
Basavatarakam Indo-American Hospital
City
Hyderabad
ZIP/Postal Code
500034
Country
India
Facility Name
Bhagwan Mahaveer Cancer Hospital & Research Centre
City
Jaipur
ZIP/Postal Code
302017
Country
India
Facility Name
Cytecare Hospitals Pvt. Ltd
City
Karnataka
ZIP/Postal Code
560064
Country
India
Facility Name
Apollo Multispeciality Hospital Ltd
City
Kolkata
ZIP/Postal Code
700019
Country
India
Facility Name
Tata Medical Center
City
Kolkata
ZIP/Postal Code
700156
Country
India
Facility Name
Jawaharlal Institute of Postgraduate Medical Education and Research
City
Pondicherry
ZIP/Postal Code
605008
Country
India
Facility Name
Deenanath Mangeshkar Hospital and Research Centre
City
Pune
ZIP/Postal Code
411004
Country
India
Facility Name
Noble Hospital Pvt Ltd
City
Pune
ZIP/Postal Code
411013
Country
India
12. IPD Sharing Statement
Learn more about this trial
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
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