Prospective study of acalabrutinib monotherapy for CLL in elderly and/or frail patients

Frail patients and patients aged 80 years or older are underrepresented in CLL clinical trial. The prospective CLL-Frail trial, in Germany and Austria, evaluated acalabrutinb monotherapy for these patients. The ORR for the 46 patients receiving ≥ 3 cycles was 93.5%, meeting the primary endpoint. The 12-months progression-free survival and overall survival rates were 93.3% and 95.7%, respectively. More than half (53.5%) of patients reported improvement in their self-perceived frailty. Although all patients experienced adverse events (grade ≥ 3 in 63.5%), there were no events of severe bleeding, and atrial fibrillation was rare. The authors conclude that these results suggest that acalabrutinib monotherapy is highly effective and safe as treatment for CLL in elderly and frail patients.