This multicenter, open-label, phase I study assessed the safety and antitumor activity of acalabrutinib in Japanese patients with relapsed/refractory (r/r) B-cell malignancies. Parts 1 (dose-confirmation) and 2 (dose-expansion) of this three-part study are reported. Treatment was a single dose of 100 mg acalabrutinib (Day 1), followed by a washout period and then twice daily 100 mg acalabrutinib in part 1, or twice daily 100 mg acalabrutinib in part 2. Patients from parts 1 and 2 with r/r chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and r/r mantle cell lymphoma (MCL) were assessed as r/r CLL and r/r MCL cohorts, respectively. Twenty-five patients received treatment (part 1, n=6). Median age was 71.0 years. Nine (one patient from part 1) and 13 (two patients from part 1) patients were included in the r/r CLL and r/r MCL cohorts, respectively. Treatment-related AEs occurred in 88% of patients (grade ≥3, 36%); the most common were headache (28%) and purpura (24%), both grade 1/2. No AEs resulted in treatment discontinuation or death. Median duration of treatment was 31, 20, and 7 months for part 1, r/r CLL/SLL cohort, and r/r MCL cohort, respectively. ORR was 89% and 62% for the r/r CLL/SLL and r/r MCL cohorts, respectively. The median PFS was not reached for the r/r CLL/SLL cohort and was 7 months for the r/r MCL cohort. Acalabrutinib (100 mg twice daily) was generally safe and well-tolerated in adult Japanese patients with B-cell malignancies.This article is protected by copyright. All rights reserved.
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Koji Izutsu
Kiyoshi Ando
Daisuke Ennishi
Hirohiko Shibayama
Junji Suzumiya
Kazuhito Yamamoto
Satoshi Ichikawa
Koji Kato
Kyoya Kumagai
Priti Patel
Sakura Iizumi
Nobuya Hayashi
Hisashi Kawasumi
Kosho Murayama
Hirokazu Nagai
References
PubMed