Phase II Study of Acalabrutinib, Venetoclax, and Obinutuzumab in a Treatment-Naive Chronic Lymphocytic Leukemia Population Enriched for High-Risk Disease.

ABSTRACT:

Purpose

The AMPLIFY trial recently established fixed-duration acalabrutinib, venetoclax, and obinutuzumab (AVO) as a new standard-of-care option for patients with previously untreated chronic lymphocytic leukemia (CLL) with wild-type TP53; however, due to the chemoimmunotherapy control arm, AMPLIFY excluded patients with high-risk TP53 aberration, for whom current standards of care are continuous Bruton tyrosine kinase inhibitor therapy or alternatively fixed-duration venetoclax-based doublets. AVO has not previously been evaluated in patients with CLL with TP53 aberration.

Methods

This investigator-sponsored, multicenter, phase II study enrolled patients with treatment-naïve CLL enriched for high-risk CLL, defined by TP53 aberration (ClinicalTria

SUBMITTER: Davids MS 

PROVIDER: S-EPMC11996140 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature