Studies ibrutinib and venetoclax treatment for chronic lymphocytic leukemia in routine care
Observes how ibrutinib and venetoclax work in adults with chronic lymphocytic leukemia.
Plain-language title generated from the registry record
Registry 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
Key facts
- Where
- Bucharest, RomaniaSee the site
Where in Romania
- Spitalul Universitar de Urgență BucureștiBucharest, RomaniaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Janssen Research & Development, LLC
- Trial code
- NCT07602088
- Record updated
- 3 November 2026
- Original description
The purpose of this study is to see how well Ibrutinib and Venetoclax (I+V) treatment works (effectiveness) for participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) when it is used in routine, everyday medical care.Read full original descriptionShow less
Prospective Cohort Study With Fixed-Duration Ibrutinib + Venetoclax (I+V) First-Line Treatment in Patients With Chronic Lymphocytic Leukemia in a Real-World Setting
The purpose of this study is to see how well Ibrutinib and Venetoclax (I+V) treatment works (effectiveness) for participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) when it is used in routine, everyday medical care.
Inclusion: Has a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) requiring treatment according to international workshop on chronic lymphocytic leukemia (iwCLL) 2018 guidelines; Intented for the treatment with fixed-duration ibrutinib plus venetoclax treatment (I+V) according to the approved indication. Decision to start I+V treatment must have been taken before and independently of participant's inclusion in the study; Participant must sign an informed consent form (ICF) allowing source data verification in accordance with local requirements; Is able to read, understand, and complete the PRO instruments in local language and comply with completion of all patient-reported outcome (PRO) instruments.
Exclusion: Has received an investigational medicinal product (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of the study or the first data collection time point; Falls under any restrictions or limitations preventing treatment with I+V as per the current approved label of ibrutinib or venetoclax in Romania; Has a history of CLL/SLL treatment; Is currently enrolled or plans to participate in an interventional clinical study (participation in a non-Janssen sponsored non-interventional study or registry is allowed).