ClinicaliQ Trial Snapshot
- Acalabrutinib Monotherapy vs Investigator’s Choice of Treatment in Patients With CL Leukaemia and Heart Failure — Recruiting • Phase IV • Oncology • NCT06651970.
- What is being tested: Acalabrutinib monotherapy (100 mg twice daily) versus investigator's choice of alternative treatment in a Phase IV randomised trial evaluating safety and tolerability outcomes in chronic lymphocytic leukaemia (CLL) patients.
- Patient eligibility overview: The study includes treatment-Phase IVïve (TN) or relapsed/refractory (R/R) CLL patients with concurrent heart failure, addressing a clinically complex population often excluded from standard trials.
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What This Trial Is Studying
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…
Eligibility Snapshot
- : 1. Men and women ≥ 18 years of age, at the time of signing the informed consent. 2. Eastern Cooperative Oncology Group performance status of 0 to 3 3. Left ventricular ejection fraction assessed by ECHO < 50%. 4. Diagnosis of CLL 5. Treatment naïve or relapsed/refractory patients who received no more than 2 prior lines of systemic anti-CLL treatment. 6. Active disease per iwCLL 2018 criteria that requires treatment. 7. Meet the following laboratory parameters: 1. Absolute neutrophil count (ANC) ≥ 500 cells/μL (0.50 × 109/L). 2. Platelet count ≥ 30,000 cells/μL (30 × 109/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 (ie, estimated glomerular filtration rate [eGFR] using Cockcroft-Gault) ≥ 40 mL/min, or serum creatinine ≤ 2 × ULN. 8. Women and men who are sexually active and can bear children must agree to use highly effective forms of contraception while on the study and for 2 days after the last dose of acalabrutinib. 9. Patients must be willing and able to adhere to the study visit schedule, understand, and comply with other protocol requirements, and…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.