Actively Recruiting
Real-World Study of Fixed-Duration Ibrutinib plus Venetoclax as First-Line Treatment in Patients With Chronic Lymphocytic Leukemia
Led by Janssen Research & Development, LLC · Updated on 2026-06-05
60
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how well the combination treatment of Ibrutinib and Venetoclax (I+V) works for people diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who need first-line therapy. This study observes patients receiving fixed-duration I+V treatment during routine medical care without giving any study drugs directly. The goal is to understand the treatment's effectiveness in real-world clinical settings. Participants who have confirmed CLL or SLL and have been prescribed fixed-duration Ibrutinib plus Venetoclax according to approved guidelines are included. The study collects data only from routine clinical practice, with no additional drugs administered. Treatment decisions are made independently by physicians before enrolling patients. The study follows patients through their course of care while monitoring outcomes related to response and quality of life. During the study, researchers gather data on overall response rates up to about 60 weeks, progression-free survival, overall survival, and various health-related quality of life measures up to around four years. They also track adverse events, hospitalizations, emergency visits, and factors influencing treatment decisions. Participants complete patient-reported outcome questionnaires in their local language. The study involves no extra treatment visits, focusing instead on data collected during regular care.
CONDITIONS
Brief Title
A Real-world Study of Ibrutinib and Venetoclax (I+V) First-Line Treatment Given for Fixed-duration of Time in Participants With Chronic Lymphocytic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) requiring treatment according to iwCLL 2018 guidelines
- Intended for fixed-duration treatment with ibrutinib plus venetoclax
- Decision to start I+V treatment made before and independent of study inclusion
- Able to read, understand, and complete patient-reported outcome questionnaires in local language
- Signed informed consent allowing source data verification as per local requirements
You will not qualify if you...
- History of prior treatment for CLL or SLL
- Received investigational drug or invasive investigational device within 30 days before study start
- Currently enrolled or planning to participate in an interventional clinical study
- Subject to restrictions preventing treatment with ibrutinib or venetoclax per approved label in Romania
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to approximately 4 years
Participants who undergo routine care with ibrutinib plus venetoclax as first-line treatment for chronic lymphocytic leukemia are observed. Data on treatment response, adverse events, and quality of life are collected during routine clinical practice.
Trial Site Locations
Total: 1 location
1
Spitalul Universitar de Urgenta Bucuresti
Bucharest, Romania, 050098
Actively Recruiting
Research Team
S
Study Contact
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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