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

  • Chronic Lymphocytic Leukaemia
  • Moderate to Severe Cardiac Impairment

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. Patients with moderate to severe cardiac impairment will include those with moderate to severe cardiac conditions, who may have been excluded from previous acalabrutinib clinical trials and in whom the safety of acalabrutinib was not systematically assessed. The study is planned to take place in approximately 25 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

First listed
Oct 22, 2024
Start date
Feb 4, 2025
Status verified
Aug 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-

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