Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:02 PM
Ignite Modification Date:
2025-12-24 @ 1:02 PM
NCT ID:
NCT03720561
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03720561
Study Brief:
Protocol Section:
NCT03720561