Study identifier:D8223C00016
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
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
Chronic lymphocytic leukaemia, heart failure
Phase 4
No
Acalabrutinib
All
60
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Other
Verified 01 Oct 2024 by AstraZeneca
AstraZeneca
Fortrea Inc., CALYX Inc., eResearch Technology Inc., CISCRP Inc.
No locations available
Arms | Assigned Interventions |
---|---|
Active Comparator: Treatment Arm A (Acalabrutinib Monotherapy) All participants randomised to Arm A will receive treatment with the investigational product acalabrutinib. | Drug: Acalabrutinib Acalabrutinib Monotherapy Other Name: Calquence |
Other: Treatment Arm B Patients in Arm B will receive investigator’s choice of treatment its duration will be based on standard duration of therapy for that regimen or until disease progression/patient withdrawal/study termination, whichever occurs first. | Other: Unknow control arm treatment type will be defined by the PI prior to randomisation Other Name: unknow |