NCT03836261

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

A Randomized, Multicenter, Open-Label, Phase 3 Study to Compare the Efficacy and Safety of Acalabrutinib (ACP-196) in Combination With Venetoclax With and Without Obinutuzumab Compared to Investigator's Choice of Chemoimmunotherapy in Subjects With Previously Untreated Chronic Lymphocytic Leukemia Without Del(17p) or TP53 Mutation (AMPLIFY)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 984 (actual)
• Sponsor: Acerta Pharma BV · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

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 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 (35 days), treatment (from randomization until study drug discontinuation) and follow-up phase.

Conditions

• Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	Acalabrutinib	Acalabrutinib,
DRUG	Venetoclax	Venetoclax
DRUG	Chemoimmunotherapy	fludarabine/cyclophosphamide/rituximab (FCR), bendamustine/rituximab (BR)
DRUG	Obinutuzumab	Obinutuzumab

Timeline

• Start date: 2019-02-25
• Primary completion: 2027-01-31
• Completion: 2027-01-31
• First posted: 2019-02-11
• Last updated: 2024-12-27

Locations

170 sites across 27 countries: United States, Argentina, Australia, Austria, Brazil, Bulgaria, Canada, China, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Russia, Saudi Arabia, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study