Ibrutinib and Venetoclax in CLL/SLL: Long-Term Outcomes After Frontline CAPTIVATE
Official title: Long-Term Outcomes of Ibrutinib Plus Venetoclax in Patients With Chronic Lymphocytic Leukemia in Routine Clinical Practice
Run by European Research Initiative on CLL · NCT07774390 · Data updated 2026-11-12
This study follows people with CLL or SLL who previously received the ibrutinib plus venetoclax combination in CAPTIVATE to see how they do over time and what treatments they need if the disease returns.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 323 (estimated) |
| Sponsor | European Research Initiative on CLL Research network |
| Drugs / interventions | ibrutinib |
| Locations | 1 site (Milan) |
| Status | Recruiting |
| Started | December 18, 2025 |
| Main results expected | March 1, 2028 |
| Study ends | November 20, 2034 |
| Registry record updated | August 19, 2026 |
| Trial ID | NCT07774390 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are individuals with CLL or SLL who completed frontline ibrutinib plus venetoclax in CAPTIVATE and can provide informed consent at a participating center.
✕Probably not a fit
Patients who did not receive CAPTIVATE frontline therapy or who cannot participate in long-term follow-up may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study tracks long-term health outcomes for patients with CLL or SLL who were treated with ibrutinib plus venetoclax in CAPTIVATE. Researchers will document subsequent therapies after frontline treatment, monitor long-term safety, and assess how the disease may develop resistance over time. The study focuses on real-world, post-frontline experiences to understand durability and subsequent care. Data collection centers on patients’ treatments, adverse events, and disease status during follow-up. It is conducted at participating centers with prior CAPTIVATE enrollment.
Why it matters
Potential benefit: If successful, the study could clarify long-term safety and sequencing of therapies for CLL/SLL after frontline treatment with ibrutinib and venetoclax.
How similar studies have gone: Previous CAPTIVATE-related follow-up efforts have provided insights into durability, but long-term, real-world data remain limited and ongoing.
Who can join: the full rules
Show full inclusion / exclusion criteria
Individuals who meet all of the inclusion criteria will be eligible to participate in the study. 1. Participant is willing and able to give informed consent for participation in this study. 2. Previously enrolled into the CAPTIVATE study. 3. Being treated in a center that has agreed to participate in this follow-up study. Exclusion Criteria: The only exclusion criterion of this study: 1\. Inability or refusal to provide informed consent.
Where it's running
-
IRCCS Ospedale San Raffaele
Milan, Italy Recruiting
Study contacts
- Study coordinator: Paolo Ghia, Prof
- Email: ghia.paolo@hsr.it
- Phone: +39 02 26433919
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Acalabrutinib and Venetoclax for relapsed CLL/SLL after initial BTKi+BCL2i response
This trial tests a finite-duration combination of acalabrutinib and venetoclax in adults whose CLL or SLL has relapsed after a first-line BTKi+BCL2i therapy and who had at least 2 years of response.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.