Ibrutinib in Japanese patients with relapsed/refractory B-cell malignancies: final analysis of phase I study
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A phase I, open-label, dose-escalation study (first human study of ibrutinib in Japan) assessed the safety and antitumor activity of single-agent ibrutinib in Japanese patients with relapsed/refractory mature B-cell malignancies (RRBCM) (NCT01704963). The primary analysis was reported previously . Here we report the final analysis; median duration of follow-up was 32.4 months (range 5.1–48.8).
The study was conducted at four Japanese sites (September 2012–February 2017) and enrolled adults ≥ 20 years with RRBCM (≥ 1 prior treatment). Fifteen patients across three cohorts received ibrutinib, with multiple-dose regimens selected per approved dose levels in chronic lymphocytic leukemia (CLL) (420 mg) and mantle cell lymphoma (MCL) (560 mg):
Cohort 1 [N = 3: CLL/small lymphocytic lymphoma (SLL), n = 2; follicular lymphoma, n = 1] received ibrutinib in two phases: single-dose phase (140 mg and 280 mg) and multiple-dose phase (420 mg/day)
Cohort 2 (N = 6: CLL/SLL, n = 3; MCL, n = 2;...
This study was funded by Janssen Pharmaceutical K.K. We thank the patients who participated in this trial and their families. Writing assistance was provided by Safeer Mughal, PhD, of PAREXEL, and was funded by Janssen Global Services. The data sharing policy of Janssen Pharmaceutical Companies of Johnson & Johnson is available at https://www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at http://yoda.yale.edu.
Compliance with ethical standards
Conflict of interest
KT received grants and personal fees from Celgene, Chugai, Eisai, Janssen, Kyowa Hakko Kirin, Mundipharma, Ono, Takeda; personal fees from HUYA and Zenyaku Kogyo; grants from AbbVie, GSK SERVIER. NF received grants from Janssen. TU received personal fees from BMS, Celgene, Chugai, Eisai, Janssen, Kyowa Hakko Kirin, Novartis, Mundipharma, Nippon Shinyaku, Otsuka, Pfizer Takeda. TN is employed by Janssen.