Acalabrutinib Monotherapy vs Investigator's Choice of Treatment in Patients With CL Leukaemia and Heart Failure
← catalyst calendarNCT06651970 · readout in 1,458 d
Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →. With Fortrea, CALYX Inc., eResearch Technology, Inc., CISCRP.
Phase
Phase 4
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Other
Enrollment
60estimated
Sites
23
Countries
Czechia, Italy, Poland +3
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-02-04 | actual | When the study began enrolling |
| Primary completion | 2030-08-16 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2030-08-16 | estimated | The whole study's end, after follow-up |
| First posted | 2024-10-22 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-14 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Chronic Lymphocytic Leukaemia
- Moderate to Severe Cardiac Impairment
Interventions
- Drug: Acalabrutinib — also filed as Calquence
- Other: Investigator's choice of treatment — also filed as Investigator's choice of treatment : i.e venetoclax, Rituximab, Obinutuzumab, Zanubrutinib etc.
Primary outcomes
what the primary-completion date above is the date OFSafety endpoints 1: To evaluate the incidence of CV (CardioVascular) adverse events leading to drug discontinuation after acalabrutinib treatment compared to investigators choice of treatment.
measured Visits are screening+ 8 visits( every 4 weeks) and then every 16 weeks until termination of the study which would be 4 years from the last subject randomized.
Safety endpoints 2: To evaluate the duration on treatment prior to drug discontinuation due to CV adverse events after acalabrutinib treatment compared to investigators choice of treatment.
measured Visits are screening+ 8 visits( every 4 weeks) and then every 16 weeks until termination of the study which would be 4 years from the last subject randomized.
Safety endpoints 3: To evaluate the incidence of life threatening and fatal cardiac events of interest after acalabrutinib treatment compared to investigators choice of treatment.
measured Visits are screening+ 8 visits( every 4 weeks) and then every 16 weeks until termination of the study which would be 4 years from the last subject randomized.
Safety endpoints 4: To evaluate the frequency of grade≥3 Adverse events after acalabrutinib treatment compared to investigators choice of treatment.
measured Visits are screening+ 8 visits( every 4 weeks) and then every 16 weeks until termination of the study which would be 4 years from the last subject randomized.
Safety endpoints 5: To evaluate the frequency of AESI per Acalabrutinib IB after acalabrutinib treatment compared to investigators choice of treatment.
measured Visits are screening+ 8 visits( every 4 weeks) and then every 16 weeks until termination of the study which would be 4 years from the last subject randomized.
Safety endpoints 6: To evaluate the rate of discontinuation due to non-CV adverse events after acalabrutinib treatment compared to investigators choice of treatment.
measured Visits are screening+ 8 visits( every 4 weeks) and then every 16 weeks until termination of the study which would be 4 years from the last subject randomized.
Safety endpoints 7: To evaluate the rate of any serious adverse event after acalabrutinib treatment compared to investigators choice of treatment.
measured Visits are screening+ 8 visits( every 4 weeks) and then every 16 weeks until termination of the study which would be 4 years from the last subject randomized.
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