Study of Acalabrutinib (ACP-196) in combination with Venetoclax (ABT-199), with and without Obinutuzumab (GA101) versus Chemoimmunotherapy for Previously Untreated CLL

Study identifier:ACE-CL-311

ClinicalTrials.gov identifier:NCT03836261

EudraCT identifier:2018-002443-28

CTIS identifier:N/A

Recruiting

Official Title

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

Medical condition

Chronic Lymphocytic Leukemia

Phase

Phase 3

Healthy volunteers

No

Study drug

Acalabrutinib, Venetoclax, Chemoimmunotherapy, Obinutuzumab

Sex

All

Estimated Enrollment

780

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 25 Feb 2019
Estimated Primary Completion Date: 06 Jan 2027
Estimated Study Completion Date: 06 Jan 2027

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2023 by AcertaPharma

Sponsors

AcertaPharma

Collaborators

AstraZeneca

Inclusion and exclusion criteria