Studies ibrutinib and venetoclax treatment for chronic lymphocytic leukemia in routine care
Observes how ibrutinib and venetoclax work in adults with chronic lymphocytic leukemia.
Key facts
- Who runs it
- Janssen Research & Development, LLC
- Where
- Bucharest, RomaniaSee the site
- Trial code
- 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
- Status
- Recruiting
- People taking part
- 60 people, planned
- Started
- 18 May 2026
- Expected to end
- 30 Nov 2029
- Type of study
- Observational
- Record updated
- 3 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who need treatment and are about to start ibrutinib plus venetoclax as their first treatment in routine care.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- CLL or SLL that needs treatment according to the iwCLL 2018 guidelines.
- Earlier treatment
- Cannot have had any earlier treatment for CLL/SLL. The decision to start ibrutinib plus venetoclax (I+V) must have been made before and independently of joining the study.
Main reasons for not taking part
- Any earlier treatment for CLL/SLL
- An investigational medicine, vaccine or device used within 30 days before the study start
- Currently in, or planning to join, an interventional clinical study
- Any restriction that prevents treatment with I+V under the approved label in Romania
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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)
Where in Romania
- Spitalul Universitar de Urgență BucureștiBucharest, RomaniaTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Participants
Participants with a confirmed diagnosis of CLL/SLL requiring first-line treatment, per international workshop on chronic lymphocytic leukemia (iwCLL) 2018 or at the discretion of the treating physician using ibrutinib plus venetoclax treatment in routine clinical practice will be enrolled in this study. No drug will be administered and only data available within routine clinical practice will be collected in this study.
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Prospective Cohort Study With Fixed-Duration Ibrutinib + Venetoclax (I+V) First-Line Treatment in Patients With Chronic Lymphocytic Leukemia in a Real-World Setting
- Plain-language title
- Studies ibrutinib and venetoclax treatment for chronic lymphocytic leukemia in routine careGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 3 November 2026