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AMPLIFY is the trial behind the first all-oral, fixed-duration CLL regimen approved in the US (February 2026): 14 cycles of two pills, then stop.
AMPLIFY, trial NCT03836261 sponsored by AstraZeneca and published in the New England Journal of Medicine in 2025, is the trial behind the first all-oral, fixed-duration regimen approved for chronic lymphocytic leukaemia in the United States on 19 February 2026: fourteen cycles of acalabrutinib and venetoclax, then stop. It randomised 867 fit, previously untreated patients without del(17p) to acalabrutinib plus venetoclax, the same with obinutuzumab, or chemoimmunotherapy, met its primary progression-free survival endpoint for both experimental arms at three years, and showed a survival advantage for the doublet partly driven by COVID-19 deaths in the chemotherapy arm. Whether the triplet is worth its extra toxicity is the open question.
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.
867 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival at 3 yearsprimary | Acalabrutinib + venetoclax | 291 | 76.5% | - | - | link |
| Acalabrutinib + venetoclax + obinutuzumab | 286 | 83.1% | ||||
| Chemoimmunotherapy (FCR/BR) | 290 | 66.5% | ||||
| Progression-free survival (AV vs CIT) | Acalabrutinib + venetoclax | - | - | 0.65 (0.49 to 0.87) | - | link |
| Chemoimmunotherapy | - | - |
Shares BTK inhibitor + venetoclax, fixed duration, AMPLIFY: fixed-duration acalabrutinib plus venetoclax, with or without obinutuzumab, versus chemo-immunotherapy in fit CLL patients, Obinutuzumab, BTK (Bruton tyrosine kinase).
Shares Acalabrutinib, Obinutuzumab, BTK (Bruton tyrosine kinase), Chronic lymphocytic leukaemia, first treatment.
Shares IGHV mutational status, del(17p) / TP53 aberration in CLL, Acalabrutinib, Obinutuzumab.
Shares BTK inhibitor + venetoclax, fixed duration, Obinutuzumab, BTK (Bruton tyrosine kinase), Chronic lymphocytic leukaemia, first treatment.
Shares IGHV mutational status, AMPLIFY: fixed-duration acalabrutinib plus venetoclax, with or without obinutuzumab, versus chemo-immunotherapy in fit CLL patients, Obinutuzumab, BTK (Bruton tyrosine kinase).
Shares Acalabrutinib, Obinutuzumab, Chronic lymphocytic leukaemia, first treatment, Venetoclax.
Shares Acalabrutinib, Obinutuzumab, Chronic lymphocytic leukaemia, first treatment, Venetoclax.
Shares Obinutuzumab, Chronic lymphocytic leukaemia, first treatment, BCL-2, CD20.