{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,7]],"date-time":"2026-11-07T10:29:29Z","timestamp":1794047369265,"version":"4.8.0"},"reference-count":37,"publisher":"Ferrata Storti Foundation (Haematologica)","issue":"11","license":[{"start":{"date-parts":[[2020,10,29]],"date-time":"2020-10-29T00:00:00Z","timestamp":1603929600000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["haematol"],"abstract":"<jats:p>Venetoclax (Ven), an orally administered, potent BCL-2 inhibitor, has demonstrated efficacy in chronic lymphocytic leukemia (CLL) in combination with rituximab (R) or obinutuzumab (G). Our aim was to investigate the addition of bendamustine (B) to these Ven-containing regimens in relapsed\/refractory (R\/R) or first-line (1L) CLL. This multi-arm, nonrandomized, open-label, phase Ib study was designed to evaluate the maximum tolerated dose (MTD) and safety\/tolerability of Ven with BR\/BG, with 3+3 dose-escalation followed by safety expansion. Patients received Ven (schedule A) or BR\/BG first (schedule B) to compare safety and determine dose\/schedule for expansion. Six Ven-BR\/-BG cycles were to be administered, then Ven monotherapy until disease progression (R\/R) or fixed-duration 1- year treatment (1L). Overall, 33 R\/R and 50 1L patients were enrolled. No dose-limiting toxicities were observed (doses 100\u2013400 mg), and the MTD was not reached. Safety was similar between schedules; no tumor lysis syndrome occurred during dose-finding. Schedule B and Ven 400 mg were chosen for expansion. The most frequent grade 3\u20134 toxicity was neutropenia: R\/R 64%, 1L Ven-BR 85%, 1L Ven-BG 55%. Grade 3\u20134 infection rate was: R\/R 27%, 1L Ven-BR 0%, 1L Ven-BG 27%. During expansion, one clinical and two laboratory tumor lysis syndrome cases occurred. Fewer than half the patients completed six combination therapy cycles with all study drugs; rates of bendamustine discontinuation were high. Overall response rate was 91% in R\/R and 100% in 1L patients (16 of 49 1L patients received Ven for &gt;1 year). In conclusion, addition of bendamustine to Ven-R\/-G increased toxicity without apparent efficacy benefit (clinicaltrial gov. Identifier: NCT01671904).<\/jats:p>","DOI":"10.3324\/haematol.2020.261107","type":"journal-article","created":{"date-parts":[[2020,10,29]],"date-time":"2020-10-29T14:42:29Z","timestamp":1603982549000},"page":"2834-2844","source":"Crossref","is-referenced-by-count":5,"title":["Venetoclax plus bendamustine-rituximab or bendamustine-obinutuzumab in chronic lymphocytic leukemia: final results of a phase Ib study (GO28440)"],"prefix":"10.3324","volume":"106","author":[{"given":"Stephan","family":"Stilgenbauer","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Franck","family":"Morschhauser","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Clemens-Martin","family":"Wendtner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guillaume","family":"Cartron","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Hallek","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barbara","family":"Eichhorst","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark F.","family":"Kozloff","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Giever","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gerard","family":"Lozanski","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yanwen","family":"Jiang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Huang","family":"Huang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniela Soriano","family":"Pignataro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","family":"Schary","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathryn","family":"Humphrey","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mehrdad","family":"Mobasher","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gilles","family":"Salles","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1856","published-online":{"date-parts":[[2020,10,29]]},"reference":[{"key":"30777","doi-asserted-by":"crossref","unstructured":"Gribben JG, O'Brien S. 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