Publication date: Sep 04, 2025
Because frail and patients ≥80 years with 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 endpoint was the overall response rate (ORR) after 6 cycles of treatment to test the null hypothesis of ORR ≤ 65%. 53 patients were included into the trial and 34 patients are still on therapy. Adverse events (AEs) were the most frequent reason for early discontinuation (ten patients), whereas five 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 ≥3 cycles of treatment was 93. 5% (95% confidence interval 82. 1 – 98. 6) meeting the primary endpoint of this trial (p
| Concepts | Keywords |
|---|---|
| Month | Acalabrutinib |
| Old | Aes |
| Therapy | Clinical |
| Underrepresented | Cll |
| Cycles | |
| Endpoint | |
| Events | |
| Frail | |
| Orr | |
| Patients | |
| Primary | |
| Treatment | |
| Trial | |
| Trials | |
| Years |
Semantics
| Type | Source | Name |
|---|---|---|
| drug | DRUGBANK | Acalabrutinib |
| drug | DRUGBANK | Pentaerythritol tetranitrate |
| disease | MESH | death |
| disease | MESH | frailty |
| disease | MESH | bleeding |
| disease | MESH | atrial fibrillation |