Long-term follow-up of ibrutinib plus venetoclax treatment in chronic lymphocytic leukemia
Follows people with chronic lymphocytic leukemia treated earlier with ibrutinib and venetoclax.
Plain-language title generated from the registry record
Registry title: Ibrutinib Plus Venetoclax Long-Term Outcomes in CLL
Key facts
- Where
- Milan, ItalySee the site
Where in Italy
- IRCCS Ospedale San RaffaeleMilan, ItalyTaking 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
- European Research Initiative on CLL
- Trial code
- NCT07774390
- Record updated
- 19 August 2026
- Original description
This study is focused on tracking the long-term health of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) treated with a combination of two drugs, ibrutinib and venetoclax, as part of the original CAPTIVATE clinical trial.Read full original descriptionShow less
Long-Term Outcomes of Ibrutinib Plus Venetoclax in Patients With Chronic Lymphocytic Leukemia in Routine Clinical Practice
This study is focused on tracking the long-term health of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) treated with a combination of two drugs, ibrutinib and venetoclax, as part of the original CAPTIVATE clinical trial.
Purpose and Goals While new treatments have significantly improved survival for patients with CLL, the disease remains incurable and often requires multiple rounds of treatment over a person's life. The primary goal of this study is to understand what happens to patients after they have completed their initial (frontline) treatment with a combination of two drugs, ibrutinib and venetoclax, as part of the original CAPTIVATE clinical trial.
Researchers specifically want to:
* Identify the types and frequency of "second-line" treatments patients receive if their disease returns. * Assess the long-term safety and effectiveness of the initial ibrutinib and venetoclax treatment. * Study how the disease might become resistant to these treatments over time. Who Can Participate? The study is specifically for individuals who were previously enrolled in the original CAPTIVATE study. Only patients at participating medical centers who provide their informed consent can join.
Study Methods and Procedures This is an observational study, meaning researchers will monitor patients' health during their routine medical care rather than testing a new, experimental treatment.
Key aspects of the study include:
* Long-Term Monitoring: Patients will be followed for up to 10 years. * Data Collection: Researchers will collect information on disease status, treatment history, new health issues (comorbidities), and survival. * Optional Testing: With additional consent, patients may provide blood samples every six months to check for "measurable residual disease" (MRD)-very small amounts of cancer cells that remain after treatment. * Genetic Analysis: If a patient's CLL progresses, researchers may analyze blood samples to look for specific genetic mutations that might explain why the treatment stopped working.
Participation is entirely voluntary, and patients can choose to withdraw from the study or opt out of specific tests (like blood sampling) at any time without affecting their standard medical care.
Exclusion: The only exclusion criterion of this study:; Inability or refusal to provide informed consent.
Individuals who meet all of the inclusion criteria will be eligible to participate in the study; Participant is willing and able to give informed consent for participation in this study; Previously enrolled into the CAPTIVATE study; Being treated in a center that has agreed to participate in this follow-up study.