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Pharmacol"],"published-print":{"date-parts":[[2022,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Purpose<\/jats:title>\n                <jats:p>This phase I\/II clinical study was conducted to examine the safety, tolerability, pharmacokinetics, and efficacy of 10-min dosing of bendamustine in patients with previously untreated indolent B-cell non-Hodgkin lymphoma (iNHL) or mantle cell lymphoma (MCL) (Group 1) and patients with relapsed\/refractory diffuse large B-cell lymphoma (rrDLBCL) (Group 2).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Rituximab 375\u00a0mg\/m<jats:sup>2<\/jats:sup> was administered intravenously every 28\u00a0days to Group 1 patients on day 1 and every 21\u00a0days to Group 2 patients on day 1. Bendamustine 90\u00a0mg\/m<jats:sup>2<\/jats:sup>\/day was administered to the former on days 1 and 2; bendamustine 120\u00a0mg\/m<jats:sup>2<\/jats:sup>\/day was administered to the latter on days 2 and 3. Each regimen was delivered up to six cycles for both groups. The primary endpoints were safety and tolerability in Groups 1 and 2, respectively.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Among 37 enrolled patients, safety was assessed in 36. In Group 1 (<jats:italic>n<\/jats:italic>\u2009=\u200930), 27 patients (90%) had follicular lymphoma. Adverse events (AEs) were observed in all 30 patients in Group 1. Dose-limiting toxicities were observed in two of six patients in Group 2. Common AEs included lymphocyte count decreased (86.7%, 100%). In Group 1, overall response and complete response rates were 93.1% (95% confidence interval [CI] 77.2\u201399.2%) and 75.9% (95% CI 56.5\u201389.7%), respectively. The <jats:italic>C<\/jats:italic><jats:sub>max<\/jats:sub> and AUC of bendamustine tended to be higher in Group 2 than in Group 1.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>This study showed that bendamustine is safe, well-tolerated and effective for patients with previously untreated iNHL, MCL or rrDLBCL. Pharmacokinetic data were equivalent to those obtained outside of Japan.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Registration numbers<\/jats:title>\n                <jats:p>Registration NCT03900377; registered April 3, 2019.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s00280-022-04442-2","type":"journal-article","created":{"date-parts":[[2022,7,7]],"date-time":"2022-07-07T14:08:52Z","timestamp":1657202932000},"page":"83-95","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["A phase I\/II study of 10-min dosing of bendamustine hydrochloride (rapid infusion formulation) in patients with previously untreated indolent B-cell non-Hodgkin lymphoma, mantle cell lymphoma, or relapsed\/refractory diffuse large B-cell lymphoma in Japan"],"prefix":"10.1007","volume":"90","clinical-trial-number":[{"clinical-trial-number":"nct03900377","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4911-8889","authenticated-orcid":false,"given":"Kenichi","family":"Ishizawa","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masahiro","family":"Yokoyama","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Harumi","family":"Kato","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kazuhito","family":"Yamamoto","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masanori","family":"Makita","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kiyoshi","family":"Ando","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yasunori","family":"Ueda","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yoshimichi","family":"Tachikawa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Youko","family":"Suehiro","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mitsutoshi","family":"Kurosawa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yoshihiro","family":"Kameoka","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hirokazu","family":"Nagai","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nobuhiko","family":"Uoshima","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takayuki","family":"Ishikawa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michihiro","family":"Hidaka","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yoshikiyo","family":"Ito","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Atae","family":"Utsunomiya","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Koji","family":"Fukushima","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michinori","family":"Ogura","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2022,7,7]]},"reference":[{"key":"4442_CR1","doi-asserted-by":"publisher","first-page":"799","DOI":"10.1188\/08.CJON.799-806","volume":"12","author":"S Blumel","year":"2008","unstructured":"Blumel S, Goodrich A, Martin C, Dang NH (2008) Bendamustine: a novel cytotoxic agent for hematologic malignancies. 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Lancet 381:1203\u20131210. https:\/\/doi.org\/10.1016\/S0140-6736(12)61763-2","journal-title":"Lancet"}],"container-title":["Cancer Chemotherapy and Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00280-022-04442-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s00280-022-04442-2\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00280-022-04442-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,7,20]],"date-time":"2022-07-20T17:07:29Z","timestamp":1658336849000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s00280-022-04442-2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,7]]},"references-count":23,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2022,7]]}},"alternative-id":["4442"],"URL":"https:\/\/doi.org\/10.1007\/s00280-022-04442-2","relation":{},"ISSN":["0344-5704","1432-0843"],"issn-type":[{"type":"print","value":"0344-5704"},{"type":"electronic","value":"1432-0843"}],"subject":[],"published":{"date-parts":[[2022,7]]},"assertion":[{"value":"20 December 2021","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"21 February 2022","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"7 July 2022","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"K. Ishizawa reports grants from SymBio, during the conduct of the study; grants from Sanofi, grants and personal fees from Novartis, grants from AbbVie, grants from Bayer, personal fees from Takeda, personal fees from Celgene, personal fees from Ono, personal fees from Chugai, personal fees from Eisai, grants from IQVIA, personal fees from SRD, personal fees from MSD, grants from Otsuka, personal fees from Micron, personal fees from Janssen, personal fees from Kyowa Kirin, outside the submitted work; M. Yokoyama reports personal fees from Chugai, outside the submitted work; H. Kato reports personal fees and others from SymBio, during the conduct of the study; others from Zenyaku Kogyo, others from Chugai, others from Incyte, others from Mundipharma, outside the submitted work; K. Yamamoto reports grants and non-financial support from SymBio, during the conduct of the study; grants and personal fees from AbbVie, personal fees from ADC, grants and personal fees from AstraZeneca, grants from Bayer, grants and personal fees from Bristol Myers Squibb\/Celgene, grants and personal fees from Chugai, personal fees from Daiichi Sankyo, grants and personal fees from Eisai, grants from IQVIA\/Genmab, personal fees from IQIVA\/HUYA, grants from IQIVA\/Incyte, personal fees from Janssen, personal fees from Kyowa Kirin, grants and personal fees from Meiji Seika Pharma, personal fees from Micron, personal fees from MSD, grants from Mundipharma, grants and personal fees from Nippon Shinyaku, grants and personal fees from Novartis, grants and personal fees from Ono, grants and personal fees from Otsuka, personal fees from Pfizer, personal fees from Sanofi, grants from Solasia, personal fees from Stemline, personal fees from Sumitomo Dainippon, grants and personal fees from SymBio, grants and personal fees from Takeda, grants and personal fees from Yakult, grants and personal fees from Zenyaku Kogyo, outside the submitted work; K. Ando reports grants from SymBio, during the conduct of the study; grants from Chugai grants from Celgene, grants from Astellas, grants from Kyowa Kirin, grants from Takeda, outside the submitted work; Y. Ueda reports other from Otsuka, during the conduct of the study; Y. Suehiro reports grants from SymBio, during the conduct of the study; grants and personal fees from Chugai, grants from Novartis, grants from Bayer, grants and personal fees from Eisai, grants and personal fees from Ono, grants and personal fees from Otsuka, grants from Pfizer, grants from Amgen Astellas BioPharma, grants and personal fees from Celgene, grants from Takeda, grants from Incyte, grants and personal fees from Kyowa Kirin, grants from Teijin, outside the submitted work; Y. Kameoka reports personal fees from Pfizer, personal fees from Kyowa Kirin, personal fees from SymBio, personal fees from HUYA, personal fees from Celgene, personal fees from Janssen, outside the submitted work; H. Nagai reports grants from the National Hospital Organization, during the conduct of the study; grants and personal fees from Janssen, grants and personal fees from Celgene, grants and personal fees from Mundipharma, grants from Bayer, grants from Abbvie, grants and personal fees from Takeda, grants and personal fees from Kyowa Hakko Kirin, grants and personal fees from Eisai, grants and personal fees from Bristol Myers Squibb, grants and personal fees from Ono, grants and personal fees from Zenyaku Kogyo, grants from Solasia, grants and personal fees from AstraZeneca, grants and personal fees from SymBio, personal fees from Sanofi, grants from IQVIA, grants from Nippon Shinyaku, personal fees from MSD, grants and personal fees from Chugai, personal fees from Novartis, personal fees from Chordia, personal fees from Sumitomo Dainippon, outside the submitted work; N. Uoshima reports grants from SymBio, grants from Otsuka, personal fees from Eisai, outside the submitted work; M. Hidaka reports grants, personal fees and non-financial support from SymBio, during the conduct of the study; grants from Chugai, outside the submitted work; A. Utsunomiya reports personal fees from Novartis, personal fees from Kyowa Kirin, personal fees from Daiichi Sankyo, personal fees from Bristol Myers, personal fees from Celgene, personal fees from Pfizer, personal fees from Minophagen, personal fees from Jansen, personal fees from JIMRO, personal fees from Chugai, personal fees from Meiji Seika Pharma, personal fees from Otsuka Medical Devices, outside the submitted work; M. Ogura reports personal fees from SymBio, during the conduct of the study; personal fees from Celgene, personal fees from Celltrion, personal fees from Meiji Seika Pharma, personal fees from Mundipharma, personal fees from Verastem, personal fees from DenovoBiopharma, personal fees from Chugai, personal fees from Yakult, personal fees from Takeda, outside the submitted work; and K. Fukushima is an employee of SymBio. The rest of authors do not have any relationships to disclose.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The present study was conducted in accordance with the International Conference on Harmonization Good Clinical Practice and with the Declaration of Helsinki and was approved by the designated ethics committees and institutional review boards at each site.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"All participants provided written informed consent.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}}]}}