Last updated on December 2019

Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199) With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL


Brief description of study

The purpose of this study is to evaluate the efficacy and safety of acalabrutinib in combination with venetoclax and acalabrutinib in combination with venetoclax with and without obinutuzumab compared to chemoimmunotherapy in subjects with previously untreated CLL.

Detailed Study Description

This randomized, global, multicenter, open-label, Phase 3 study will evaluate the efficacy and safety of AV and AVG versus chemoimmunotherapy (FCR or BR) in subjects with previously untreated CLL without del(17p) or TP53. Subjects will be randomized in a 1:1:1 ratio into 3 arms through a block stratified randomization procedure.

The study includes screening (30 days), treatment (from randomization until study drug discontinuation) and follow-up phase.

Clinical Study Identifier: NCT03836261

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