1. Phase 1/2 multicenter trial of acalabrutinib in Chinese patients with relapsed/refractory mantle cell lymphoma.
- Author
-
Song, Yuqin, Li, Jianyong, Zhou, Keshu, Ke, Xiaoyan, Cai, Zhen, Zhang, Huilai, Yao, Tingting, Xia, Zhen, Wang, Yiqiu, Lai, Peiqiong, Liu, Xiaofeng, and Zhu, Jun
- Subjects
MANTLE cell lymphoma ,CHINESE people ,PROTEIN-tyrosine kinases ,APLASTIC anemia ,TERMINATION of treatment - Abstract
Acalabrutinib studies have limited Asian participation. This phase 1/2 study (NCT03932331) assessed acalabrutinib in Chinese patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL). Primary endpoint was blinded independent central review (BICR)-assessed overall response rate (ORR). Overall, 34 patients were enrolled. Most patients were men (88%); median age was 63 years and 59% had ≥3 prior treatments. Median treatment duration was 14 months (range, 1–24). Any-grade adverse events (AEs) and grade ≥3 AEs occurred in 85.3% and 44.1% of patients, respectively. AEs causing treatment discontinuation were aplastic anemia, thrombocytopenia, and gastrointestinal infection (n = 1 each). Fatal AEs occurred in 2 patients (aplastic anemia and multiple organ dysfunction syndrome [n = 1 each]). BICR-assessed ORR was 82.4% (95% confidence interval [CI]: 65.5, 93.2); 12 (35.3%) patients achieved complete response. Estimated 12-month OS was 84.5% (95% CI: 66.6, 93.3). Acalabrutinib yielded tolerable safety and high response rates in Chinese patients with R/R MCL. [ABSTRACT FROM AUTHOR]
- Published
- 2024
- Full Text
- View/download PDF