Efficacy and Safety of Acalabrutinib Treatment in Very Old (≥80y) and/or Frail Patients with Chronic Lymphocytic Leukemia (CLL) - Primary Endpoint Analysis of the Phase II CLL-Frail Trial
Abstract
BACKGROUND: Very old and frail patients remain underrepresented in clinical trials, although accounting for roughly 20% of patients with CLL. A higher comorbidity burden and vulnerabilities in this cohort limit the use of results from younger and fit patients. The CLL-Frail trial aims to evaluate the efficacy and safety of acalabrutinib monotherapy in patients ≥80 years of age and/or a FRAIL scale score of ≥3. The FRAIL scale score is a 5-item self-assessment questionnaire for patients correlating with Fried's frailty phenotype (Abrahamian, 2017). We here present the primary endpoint analysis as pre-specified in the protocol. The analysis was performed after all patients had reached the initial response assessment (cycle 7, day 1 = approx. 6 months after initiation of therapy).
METHODS: Patients in need of treatment with previously treated and untreated CLL and ≥80 years of age and/or a FRAIL scale score ≥3 were eligible. A maximum of one previous therapy was allowed. Patients received acalabrutinib 100mg BID until progression or intolerance. The primary endpoint was overall response rate (ORR) at the initial response assessment for patients receiving at least 3 cycles of therapy (full analysis set, FAS) with the aim to test the null hypothesis of ORR ≤ 65%. Secondary endpoints included overall survival (OS), progression-free survival (PFS) as well as frequency and severity of adverse events.
RESULTS: 53 patients were included into the trial (ITT population), one patient…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 53 participants or records.
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