Acalabrutinib Monotherapy vs Investigator's Choice of Treatment in Patients With CL Leukaemia and Heart Failure (NCT06651970)
A Multicentre, Open-label, Randomised Phase IV Study to Investigate Acalabrutinib Monotherapy Compared to Investigator's Choice of Treatment in Adults (> 18 Years) With Chronic Lymphocytic Leukaemia and Moderate to Severe Cardiac Impairment
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Research Site — Charlotte, North Carolina
Age range: 18 Years to 130 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (23 Sites)
- Research Site — Charlotte, North Carolina
- Research Site — Columbus, Ohio
- Research Site — Philadelphia, Pennsylvania
- Research Site — Brno,
- Research Site — Hradec Králové,
- Research Site — Prague,
- Research Site — Cagliari,
- Research Site — Florence,
- Research Site — Milan,
- Research Site — Milan,
- Research Site — Pavia,
- Research Site — Perugia,
- Research Site — Krakow,
- Research Site — Poznan,
- Research Site — Barcelona,
- Research Site — Madrid,
- Research Site — Seville,
- Research Site — Bournemouth,
- Research Site — Oxford,
- Research Site — Plymouth,
- Research Site — Romford,
- Research Site — Stockton,
- Research Site — Sutton Coldfield,
📞 Contact the Study Coordinator
Phone: (877) 240-9479
Email: information.center@astrazeneca.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.