Acalabrutinib, Obinutuzumab and Chlorambucil in treatment naïve CLL - ElevateTN

Study identifier:ACE-CL-007

ClinicalTrials.gov identifier:NCT02475681

EudraCT identifier:2014-005582-73

CTIS identifier:N/A

Recruitment Complete

Official Title

A Randomized, Multicenter, Open-Label, 3 Arm Phase 3 Study of Obinutuzumab in Combination with Chlorambucil, Acalabrutinib (ACP-196) in Combination with Obinutuzumab, and Acalabrutinib Monotherapy in Subjects with Previously Untreated CLL

Medical condition

Chronic Lymphocytic Leukemia

Phase

Phase 3

Healthy volunteers

No

Study drug

Acalabrutinib, Obinutuzumab, Chlorambucil

Sex

All

Actual Enrollment

535

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 26 Jun 2015
Primary Completion Date: 08 Feb 2019
Estimated Study Completion Date: 30 Sept 2025

Study design

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

Verification:

Verified 01 Sept 2024 by AcertaPharma

Sponsors

AcertaPharma

Collaborators

-

Inclusion and exclusion criteria