Clinical trial NCT03190330: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Mantle-Cell
Lead sponsor: Johnson & Johnson Private Limited
Sponsor class: INDUSTRY
First posted: 2017-06-16
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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).


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

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: Day 1 up to 30 days after last dose of study drug (up to 13 months)
measure: Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)
timeFrame: Day 1 up to 30 days after last dose of study drug (up to 13 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Avron Hospitals Pvt. Ltd
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education And Research PGIMER
city: Hyderabad
country: India
facility: Basavatarakam Indo-American Hospital
city: Jaipur
country: India
facility: Bhagwan Mahaveer Cancer Hospital & Research Centre
city: Karnataka
country: India
facility: Cytecare Hospitals Pvt. Ltd
city: Kolkata
country: India
facility: Apollo Multispeciality Hospital Ltd
city: Kolkata
country: India
facility: Tata Medical Center
city: Pondicherry
country: India
facility: Jawaharlal Institute of Postgraduate Medical Education and Research
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital and Research Centre
city: Pune
country: India
facility: Noble Hospital Pvt Ltd
Study officials:
affiliation: Johnson & Johnson Private Limited
name: Johnson & Johnson Private Limited Clinical Trial
role: STUDY_DIRECTOR
References: