Study of Acalabrutinib versus Chlorambucil plus Rituximab in Adult Subjects with Previously Untreated Chronic Lymphocytic Leukemia

Study identifier:D822BC00001

ClinicalTrials.gov identifier:NCT04075292

EudraCT identifier:N/A

CTIS identifier:N/A

Recruitment Complete

Official Title

A Randomized, Multicenter, Open-Label, Phase 3 Study to Evaluate the Efficacy and Safety of Acalabrutinib versus Chlorambucil plus Rituximab in Subjects with Previously Untreated Chronic Lymphocytic Leukemia

Medical condition

Untreated Chronic Lymphocytic Leukemia

Phase

Phase 3

Healthy volunteers

No

Study drug

Acalabrutinib, Rituximab, Chlorambucil

Sex

All

Actual Enrollment

155

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 20 Jan 2020
Estimated Primary Completion Date: 29 Nov 2024
Estimated Study Completion Date: 29 Nov 2024

Study design

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

Verification:

Verified 01 May 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria