{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T19:45:05Z","timestamp":1791229505865,"version":"4.1.0"},"reference-count":41,"publisher":"American Society of Hematology","issue":"26","content-domain":{"domain":["ashpublications.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2025,12,25]]},"abstract":"<jats:sec>\n                    <jats:title>Abstract<\/jats:title>\n                    <jats:p>Because frail patients and patients aged \u226580 years with chronic lymphocytic leukemia (CLL) are still underrepresented in clinical trials, the CLL-Frail trial aimed to evaluate the efficacy and safety of acalabrutinib in these patients. The primary end point was the overall response rate (ORR) after 6 cycles of treatment to test the null hypothesis of ORR \u226465%. Fifty-three patients were included in the trial, and 34 patients are still on therapy. Adverse events (AEs) were the most frequent reason for early discontinuation (10 patients), whereas 5 patients stopped treatment because of death. Median age was 81 years, and 47.2% of patients were frail. The ORR for the 46 patients receiving \u22653 cycles of treatment was 93.5% (95% confidence interval, 82.1-98.6) meeting the primary end point of this trial (P &amp;lt; .001). The estimated 12-month progression-free and overall survival rates were 93.3% and 95.7%, respectively, after a median follow-up of 19 months. 53.5% of patients reported an improvement in their self-perceived frailty. Although all patients experienced AEs, and severe (Common Terminology Criteria of \u22653) events were reported in 63.5% of patients, there were no events of severe bleeding and atrial fibrillation was rare (2 cases of Common Terminology Criteria Grades 2 and 3). Five patients died, of which 4 deaths happened during or &amp;lt;28 days after treatment. Infections\/COVID-19 were the cause of death in 3 cases. To our knowledge, this is the first prospective trial in older and\/or frail patients with CLL demonstrating a high efficacy and safe treatment with acalabrutinib monotherapy. This trial was registered at www.ClinicalTrials.gov as #NCT04883749.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1182\/blood.2025028550","type":"journal-article","created":{"date-parts":[[2025,9,4]],"date-time":"2025-09-04T19:23:07Z","timestamp":1757013787000},"page":"3153-3162","update-policy":"https:\/\/doi.org\/10.1182\/blood.2019cm0000","source":"Crossref","is-referenced-by-count":15,"title":["Acalabrutinib treatment for older (aged \u226580 years) and\/or frail patients with CLL: primary end point analysis of the CLL-Frail trial"],"prefix":"10.1182","volume":"146","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2700-3717","authenticated-orcid":false,"given":"Florian","family":"Simon","sequence":"first","affiliation":[{"name":"1Department I of Internal Medicine and Center of Integrated Oncology Aachen, Bonn, Cologne, D\u00fcsseldorf, Faculty of Medicine and University Hospital of Cologne, University of Cologne, Cologne, 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