# CAPTIVATE

Source: https://onco.cc/trials/captivate/  
OnCo record `captivate` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Fifteen months of two pills, then stop: three-quarters of patients had no detectable leukaemia in the blood, and most remained in remission years later.

## Summary

Fixed-duration cohort: CR 55% (primary endpoint met), uMRD in blood 77%, 4-year PFS ~79% (2024 update), retreatment with ibrutinib effective at relapse. MRD-guided cohort tested stopping vs continuing in confirmed uMRD (no PFS difference at 3 years). Blood 2022; JCO 2024. Basis (with GLOW) of the EU approval of fixed-duration ibrutinib-venetoclax.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT02910583
- Phase: 2
- Setting: Previously untreated CLL, age ≤70: 3 cycles ibrutinib lead-in then 12 cycles ibrutinib + venetoclax (fixed-duration cohort n=159; MRD-guided cohort n=164)
- Sponsor: Pharmacyclics / AbbVie
- Enrolled: 323
- Result: CR 55%; uMRD 77%; 4-year PFS ~79%.
- Outcomes: Complete response (fixed-duration cohort): Ibrutinib + venetoclax 55%; Undetectable MRD in peripheral blood: Ibrutinib + venetoclax 77%
- Replication: GLOW (randomised, older/unfit) confirmed fixed-duration ibrutinib-venetoclax superiority over chemoimmunotherapy; AMPLIFY replicated the BTKi + venetoclax fixed-duration concept with acalabrutinib.

## Sources

- ClinicalTrials.gov NCT02910583: https://clinicaltrials.gov/study/NCT02910583

## Connected records

- cancers: [Chronic lymphocytic leukaemia](https://onco.cc/cancers/cll/), [Chronic lymphocytic leukaemia, first treatment](https://onco.cc/cancers/cll-treatment-naive/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [BCL-2](https://onco.cc/targets/bcl2/), [BTK (Bruton tyrosine kinase)](https://onco.cc/targets/btk/)
- drugs: [Ibrutinib](https://onco.cc/drugs/ibrutinib/), [Venetoclax](https://onco.cc/drugs/venetoclax/)
- companies: [AbbVie (incl. ImmunoGen, Capstan)](https://onco.cc/companies/abbvie/)
- terms: [MRD-negative complete remission](https://onco.cc/terms/mrd-negative-cr/), [SMART design (sequential multiple assignment randomised trial)](https://onco.cc/terms/smart-design/), [Surrogate endpoint validation: which stand-ins have earned trust](https://onco.cc/terms/surrogate-validation/)
- people: [William G. Wierda](https://onco.cc/people/william-wierda/)
- pairings: [BTK inhibitor + venetoclax, fixed duration](https://onco.cc/pairings/btki-plus-venetoclax-fixed-duration/)
- ideas: [MRD-guided treatment duration in CLL](https://onco.cc/ideas/idea-mrd-guided-stop-cll/)

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