Acalabrutinib Monotherapy vs Investigator’s Choice of Treatment in Patients with CL Leukaemia and Heart Failure

Study identifier:D8223C00016

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Will Be Recruiting

Official Title

A Multicentre, Open-label, Randomised Phase IV Study to Investigate Acalabrutinib Monotherapy Compared to Investigator’s Choice of Treatment in Adults (> 18 Years) With Chronic Lymphocytic Leukaemia and Moderate to Severe Cardiac Impairment

Medical condition

Chronic lymphocytic leukaemia, heart failure

Phase

Phase 4

Healthy volunteers

No

Study drug

Acalabrutinib

Sex

All

Estimated Enrollment

60

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 15 Oct 2024
Estimated Primary Completion Date: 16 Aug 2030
Estimated Study Completion Date: 09 Oct 2030

Study design

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

Verification:

Verified 01 Oct 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Fortrea Inc., CALYX Inc., eResearch Technology Inc., CISCRP Inc.

Inclusion and exclusion criteria