Acalabrutinib Monotherapy vs Investigator's Choice of Treatment in Patients With CL Leukaemia and Heart Failure

Part of paid clinical trials in Charlotte, North Carolina.

Sponsor
AstraZeneca
Study ID
NCT06651970
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Acalabrutinib — DRUG
    Acalabrutinib Monotherapy
  • Investigator's choice of treatment — OTHER
    control arm treatment type will be defined by the PI prior to randomisation

Study Details

This will be a global Phase IV, open-label, randomised study to evaluate the safety and tolerability of acalabrutinib (monotherapy, 100 mg orally \[po\], twice daily \[bd\]) compared to investigator's choice of treatment, in patients with CLL (TN or R/R) and moderate to severe cardiac impairment. All patients will have cardiac impairment as defined by LVEF of \< 50%. Randomisation will be stratified by LVEF \> 40% vs ≤ 40% to stratify for moderate and severe cardiac impairment, which for this study are defined as follows: Severe cardiac impairment: in those with LVEF ≤ 40% Moderate cardiac impairment: in those with LVEF \> 40% to \< 50%. The study is planned to take place in approximately 20 centres globally. The study will be conducted in centres that have established close collaboration between the Haematology and Cardiology divisions, preferably with a cardio-oncologist on the team. An IDMC will be responsible for making recommendations for study continuation.

Key Dates

Start date
Feb 4, 2025
Status verified
May 2026
Primary completion
Aug 16, 2030
Completion
Aug 16, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Treatment Arm A (Acalabrutinib Monotherapy)
    All participants randomised to Arm A will receive treatment with the investigational product acalabrutinib.
  • 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.

Primary Outcome Measure

Safety endpoints 1: To evaluate the incidence of CV (CardioVascular) adverse events leading to drug discontinuation after acalabrutinib treatment compared to investigators choice of treatment. [ Time Frame: 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. ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Research SiteCharlotteNorth Carolina28204-
Research SiteColumbusOhio43210-
Research SitePhiladelphiaPennsylvania19104-

Find similar trials in Charlotte, NC

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Research Site· Charlotte, NCResearch Site· Columbus, OHResearch Site· Philadelphia, PA

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