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This open-label, phase I dose-escalation trial (NCT02624492) was conducted to determine the maximum tolerated dose (MTD), safety\/tolerability, and preliminary efficacy of BI 836826 in combination with gemcitabine and oxaliplatin in patients with relapsed\/refractory diffuse large B-cell lymphoma (DLBCL). <jats:italic>Methods<\/jats:italic> Eligible patients received intravenous infusions of BI 836826 on day 8 and gemcitabine 1000\u00a0mg\/m<jats:sup>2<\/jats:sup> plus oxaliplatin 100\u00a0mg\/m<jats:sup>2<\/jats:sup> on day 1, for up to six 14-day treatment cycles. Dose escalation followed the standard 3\u2009+\u20093 design. <jats:italic>Results<\/jats:italic> Of 21 treated patients, 17 had relapsed\/refractory DLBCL and four had follicular lymphoma transformed to DLBCL. BI 836826 dosing started at 25\u00a0mg and proceeded through 50\u00a0mg and 100\u00a0mg. Two dose-limiting toxicities (DLTs) occurred during cycle 1, both grade 4 thrombocytopenia lasting\u2009&gt;\u20097 days, affecting 1\/6 evaluable patients (17%) in both the 50\u00a0mg and 100\u00a0mg cohorts. Due to early termination of the study, the MTD was not determined. The most common adverse events related to BI 836826 treatment were neutropenia (52%), thrombocytopenia (48%), and anemia (48%). Eight patients (38%) experienced BI 836826-related infusion-related reactions (two grade 3). Overall objective response rate was 38%, including two patients (10%) with complete remission and six patients (29%) with partial remission. <jats:italic>Conclusions<\/jats:italic> BI 836826 in combination with GemOx was generally well tolerated but did not exceed the MTD at doses up to 100\u00a0mg given every 14 days.<\/jats:p>","DOI":"10.1007\/s10637-020-01054-6","type":"journal-article","created":{"date-parts":[[2021,2,1]],"date-time":"2021-02-01T14:07:32Z","timestamp":1612188452000},"page":"1028-1035","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["A phase Ib, open-label, dose-escalation trial of the anti-CD37 monoclonal antibody, BI 836826, in combination with gemcitabine and oxaliplatin in patients with relapsed\/refractory diffuse large B-cell lymphoma"],"prefix":"10.1007","volume":"39","author":[{"given":"Monica","family":"Balzarotti","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Massimo","family":"Magagnoli","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Miguel \u00c1ngel","family":"Canales","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paolo","family":"Corradini","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carlos","family":"Grande","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Juan-Manuel","family":"Sancho","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francesco","family":"Zaja","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anne-Marie","family":"Quinson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Val\u00e9rie","family":"Belsack","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniela","family":"Maier","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3144-0124","authenticated-orcid":false,"given":"Carmelo","family":"Carlo-Stella","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2021,2,1]]},"reference":[{"issue":"1","key":"1054_CR1","doi-asserted-by":"publisher","first-page":"74","DOI":"10.1016\/j.pathol.2017.09.006","volume":"50","author":"S Li","year":"2018","unstructured":"Li S, Young KH, Medeiros LJ (2018) Diffuse large B-cell lymphoma. 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Paolo Corradini received honoraria as a lecturer from AbbVie, Amgen, Celgene, Gilead\/Kite, Janssen, Jazz Pharmaceutics, Novartis, Roche, Sanofi, Sandoz, Takeda, and consulting fees from AbbVie, ADC Therapeutics, Amgen, Celgene, Daiichi Sankyo, Gilead, Incyte, Janssen, Kite, KiowaKirin, Novartis, Roche, Sanofi, Servier and Takeda.\u00a0Francesco Zaja received honoraria from Novartis, Amgen, Janssen, Takeda, Celgene, Abbvie, Roche, Mundipharma and Grifols.\u00a0Juan-Manuel Sancho received advisory council or committee fees from Roche, Gilead, Janssen, Celgene, Incyte, Celltrion, Novartis, and honoraria as a speaker from Roche, Gilead, Janssen, Celgene, Incyte, Takeda, Novartis, Sanofi and Servier.\u00a0Anne-Marie Quinson, Val\u00e9rie Belsack and Daniela Maier are employees of Boehringer Ingelheim.\u00a0Carmelo Carlo-Stella received honoraria from Bristol-Myers Squibb, Merck Sharp & Dohme, Servier, Amgen, Janssen Oncology, Sanofi, ADC Therapeutics, Novartis, and AstraZeneca; provided consultancy to Boehringer Ingelheim, Genenta Science, Sanofi, ADC Therapeutics, and received research funding from Rhizen Pharmaceuticals.\u00a0Monica Balzarotti, Massimo Magagnoli and Carlos Grande report no conflict of interest.\u00a0","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and\/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.\u00a0","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"Informed consent was obtained from all individual participants included in the study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}