CAPTIVATE
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.
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.
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)
Phase
Phase 2
Sponsor
Pharmacyclics / AbbVie
Registry
Headline result
CR 55%; uMRD 77%; 4-year PFS ~79%.
Reported
2021
Enrolled
323
Replication
GLOW (randomised, older/unfit) confirmed fixed-duration ibrutinib-venetoclax superiority over chemoimmunotherapy; AMPLIFY replicated the BTKi + venetoclax fixed-duration concept with acalabrutinib.
In plain words
What these results mean for people, not percentages
Complete response (fixed-duration cohort)primarysurrogate endpoint
- 55 out of 100 people had no sign of cancer on scans or tests with Ibrutinib + venetoclax.
Undetectable MRD in peripheral bloodsurrogate endpoint
- 77 out of 100 people had no detectable disease on sensitive tests with Ibrutinib + venetoclax.
Be careful
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: 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). People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
323 participants enrolled.
Undetectable MRD in peripheral blood
Ibrutinib + venetoclax77 of 100
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Complete response (fixed-duration cohort)primary | Ibrutinib + venetoclax | 159 | 55% | — | — | link |
| 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.