OncoMatch/Clinical Trials/NCT06651970
Acalabrutinib Monotherapy vs Investigator's Choice of Treatment in Patients With CL Leukaemia and Heart Failure
Is NCT06651970 recruiting? Yes, currently enrolling (Sep 2026). This Phase 4 trial studies Acalabrutinib for chronic lymphocytic leukaemia.
Treatment: Acalabrutinib — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Chronic Lymphocytic Leukemia
Performance status
ECOG 0–3(Limited self-care)
Demographics
Prior therapy
Cannot have received: btk inhibitor
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 500 cells/μL; Platelet count ≥ 30,000 cells/μL.
Kidney function
Estimated creatinine clearance (eGFR using Cockcroft-Gault) ≥ 40 mL/min, or serum creatinine ≤ 2 × ULN.
Liver function
Serum aspartate aminotransferase and ALT ≤ 3.0 × ULN; Total bilirubin ≤ 1.5 × ULN unless directly attributable to Gilbert's syndrome.
Meet the following laboratory parameters: 1. Absolute neutrophil count (ANC) ≥ 500 cells/μL (0.50 × 10^9/L). 2. Platelet count ≥ 30,000 cells/μL (30 × 10^9/L). 3. Serum aspartate aminotransferase and ALT ≤ 3.0 × ULN. 4. Total bilirubin ≤ 1.5 × ULN unless directly attributable to Gilbert's syndrome. 5. Estimated creatinine clearance (eGFR using Cockcroft-Gault) ≥ 40 mL/min, or serum creatinine ≤ 2 × ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Research Site · Charlotte, North Carolina
- Research Site · Columbus, Ohio
- Research Site · Philadelphia, Pennsylvania
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06651970 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior btk inhibitor disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 130 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages