AMPLIFY — Fixed-duration acalabrutinib plus venetoclax, with or without obinutuzumab, versus chemoimmunotherapy in first-line CLL (AMPLIFY)

Phase 3 · Chronic Lymphocytic Leukemia

Population

Untreated, fit chronic lymphocytic leukemia without del(17p) or TP53 mutation.

Primary Endpoint

Progression-free survival

Rationale

Continuous BTK inhibitors and venetoclax-obinutuzumab both improved on chemoimmunotherapy, but patients want time-limited, all-oral options. AMPLIFY tests whether a fixed-duration acalabrutinib-venetoclax combination can replace chemoimmunotherapy as a stop-and-go front-line CLL regimen.

What It Could Change

Could establish an all-oral, fixed-duration BTK-inhibitor/BCL2-inhibitor combination as a first-line standard in fit CLL patients.