Clinical trial · Observational
A Study to Evaluate Ibrutinib Retention in Chronic Lymphocytic Leukemia Participants Treated in a Real World Setting
EValuate Ibrutinib Retention iN Chronic Lymphocytic Leukemia Patients Treated in a rEal World Setting - EVIdeNCE
NCT03720561CI-TRIAL-00055751EVIdeNCEcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Lymphocytic, Chronic, B-Cell | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ibrutinib | Drug | Ibrutinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Drug: Ibrutinib
Primary outcomes (1)
- measure
- Retention Rate of Ibrutinib
- timeFrame
- Approximately up to 2 years
- description
- The retention rate is defined as the ratio of the number of participants taking ibrutinib over the number of participants at risk. The retention rate of ibrutinib treatment for (Chronic lymphocytic leukemia) CLL in Italian routine clinical practice will be measured.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.