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

Leukemia, Lymphocytic, Chronic, B-Cell Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03190330
• Other study ID #: CR108316
• Secondary ID: 54179060LYM4005
• Status: Completed
• Phase: Phase 4
• Start date: June 26, 2019
• Est. completion date: May 3, 2023

Study information

• Verified date: April 2024
• Source: Johnson & Johnson Private Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 3, 2023
• Est. primary completion date: May 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma
• Lymphoma, Mantle-Cell

Intervention

Drug:
• Ibrutinib 420 mg
Ibrutinib capsule administered orally at a dose of 420 mg for CLL participants.
• Ibrutinib 560 mg
Ibrutinib capsule administered orally at a dose of 560 mg for MCL participants.

Locations

Country	Name	City	State
India	Avron Hospitals Pvt. Ltd	Ahmedabad
India	Post Graduate Institute of Medical Education & Research (PGIMER)	Chandigarh
India	Basavatarakam Indo-American Hospital	Hyderabad
India	Bhagwan Mahaveer Cancer Hospital & Research Centre	Jaipur
India	Cytecare Hospitals Pvt. Ltd	Karnataka
India	Apollo Multispeciality Hospital Ltd	Kolkata
India	Tata Medical Center	Kolkata
India	Jawaharlal Institute of Postgraduate Medical Education and Research	Pondicherry
India	Deenanath Mangeshkar Hospital and Research Centre	Pune
India	Noble Hospital Pvt Ltd	Pune

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Private Limited

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)