A Study to Evaluate Ibrutinib Retention in Chronic Lymphocytic Leukemia Participants Treated in a Real World Setting (EVIdeNCE)

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Leukemia, Lymphocytic, Chronic, B-Cell

Treatments: Drug: Ibrutinib

Study type: Observational

Funder types: Industry

Identifiers

NCT03720561

54179060CLL4013 (Other Identifier)

CR108517

Details and patient eligibility

About

The purpose of this study is to describe the 2-year retention rate of ibrutinib treatment for chronic lymphocytic leukemia (CLL) in Italian routine clinical practice.

Enrollment: 312 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) requiring treatment (iwCLL [International Workshop on Chronic Lymphocytic Leukemia] criteria)
• If alive, must sign an Informed Consent Form (ICF) allowing data collection and source data verification in accordance with Italian requirements
• Participants with one of the following characteristics: a) Participants starting ibrutinib treatment according to the summary of product characteristics (SmPC) at enrolment or within 30 days starting from informed consent signature, as per routine clinical practice and independently of this non-interventional study; OR b) Participants who have started ibrutinib within 3 months before enrollment, according to the SmPC, as per routine clinical practice and independently of this non- interventional study (including also participants who, by the time of enrollment, are not receiving ibrutinib)
• If alive, must be able to read and write in Italian and to understand and sign the ICF

Exclusion criteria

• Currently enrolled in any interventional clinical trial
• Currently enrolled in observational studies sponsored or managed by Janssen company
• Treated with any investigational compound or any invasive investigational medical device within 30 days before start of ibrutinib treatment
• Having contraindications to ibrutinib use as described in the SmPC
• Pregnant or breast-feeding

Trial design

312 participants in 1 patient group

Group: Ibrutinib Treatment

Description:

Participants will not receive any intervention as a part of this study. This study will collect retrospective and prospective real-world data to describe retention rates for participants of chronic lymphocytic leukemia (CLL) receiving ibrutinib in routine Italian clinical practice over a 2-year follow-up period. Participants with CLL who have started ibrutinib treatment within 3 months before enrollment visit or in case ibrutinib was prescribed before or on the enrollment day as per routine clinical practice within the 30 days after enrollment visit will be included in the study. The primary data source for this observational study will be the medical records of each enrolled participant, as well as questionnaires concerning quality of life and treatment adherence. Data will be collected every 3 months for the first year and every 6 months for the second year during prospective period.

Treatment:

Drug: Ibrutinib