{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T16:49:11Z","timestamp":1784306951750,"version":"3.55.0"},"reference-count":24,"publisher":"Oxford University Press (OUP)","issue":"7","license":[{"start":{"date-parts":[[2022,3,7]],"date-time":"2022-03-07T00:00:00Z","timestamp":1646611200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Acrotech Biopharma, LLC"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,7,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>We conducted an investigator-initiated, phase I trial of vincristine sulfate liposomal injection (VSLI) in combination with bendamustine and rituximab (BR) for indolent B-cell (BCL) or mantle cell lymphoma.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Participants received 6 cycles of standard BR with VSLI at patient-specific dose determined by the Escalation with Overdose Control (EWOC) model targeting 33% probability of dose-limiting toxicity (DLT). Maximum tolerated dose (MTD) was the primary endpoint; secondary endpoints included rates of adverse events (AEs), overall response rate (ORR), and complete response (CR). Vincristine sulfate liposomal injection is FDA approved for the treatment of patients with recurrent Philadelphia chromosome-negative (Ph\u2212) acute lymphoblastic leukemia (ALL).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Among 10 enrolled patients, VSLI was escalated from 1.80 to 2.24\u00a0mg\/m2, with one DLT (ileus) at 2.04\u00a0mg\/m2. Two patients discontinued VSLI early. The most common AE included lymphopenia (100%), constipation, nausea, infusion reaction (each 60%), neutropenia, and peripheral neuropathy (50%). Grade 3\/4 AE included lymphopenia (90%), neutropenia (20%), and ileus (10%), with prolonged grade \u22652 lymphopenia observed in most patients. Calculated MTD for VSLI was 2.25\u00a0mg\/m2 (95% Bayesian credible interval: 2.00-2.40). Overall response was 100% with 50% CR. With median follow-up 26 months, 4\/10 patients experienced recurrence and 1 died.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>Vincristine sulfate liposomal injection at 2.25\u00a0mg\/m2 can be safely combined with BR for indolent B-cell lymphoma, but given observed toxicities and recurrences, we did not pursue an expanded cohort.<\/jats:p>\n                  <jats:p>Clinical Trials Registration Number: ClinicalTrials.gov identifier NCT02257242.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/oncolo\/oyab079","type":"journal-article","created":{"date-parts":[[2022,1,1]],"date-time":"2022-01-01T05:00:52Z","timestamp":1641013252000},"page":"532-e542","source":"Crossref","is-referenced-by-count":14,"title":["Vincristine Sulfate Liposome Injection with Bendamustine and Rituximab as First-Line Therapy for B-Cell Lymphomas: A Phase I Study"],"prefix":"10.1093","volume":"27","author":[{"given":"Thomas","family":"Ollila","sequence":"first","affiliation":[{"name":"Department of Medicine, Alpert Medical School of Brown University , Providence, RI , USA"},{"name":"Division of Hematology-Oncology, Rhode Island Hospital , Providence, RI , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Butera","sequence":"additional","affiliation":[{"name":"Department of Medicine, Alpert Medical School of Brown University , Providence, RI , USA"},{"name":"Division of Hematology-Oncology, Rhode Island Hospital , Providence, RI , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pamela","family":"Egan","sequence":"additional","affiliation":[{"name":"Department of Medicine, Alpert Medical School of Brown University , Providence, RI , USA"},{"name":"Division of Hematology-Oncology, Rhode Island Hospital , Providence, RI , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Reagan","sequence":"additional","affiliation":[{"name":"Department of Medicine, Alpert Medical School of Brown University , Providence, RI , USA"},{"name":"Division of Hematology-Oncology, Rhode Island Hospital , Providence, RI , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anthony","family":"Thomas","sequence":"additional","affiliation":[{"name":"Department of Medicine, Alpert Medical School of Brown University , Providence, RI , USA"},{"name":"Division of Hematology-Oncology, Rhode Island Hospital , Providence, RI , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Inna","family":"Yakirevich","sequence":"additional","affiliation":[{"name":"Division of Hematology-Oncology, Rhode Island Hospital , Providence, RI , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kelsey","family":"MacKinnon","sequence":"additional","affiliation":[{"name":"Brown University Oncology Research Group (BrUOG) , Providence, RI , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeannine","family":"Margolis","sequence":"additional","affiliation":[{"name":"Brown University Oncology Research Group (BrUOG) , Providence, RI , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica","family":"McMahon","sequence":"additional","affiliation":[{"name":"Lifespan Oncology Clinical Research , Providence, RI , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valerie","family":"Rosati","sequence":"additional","affiliation":[{"name":"Lifespan Oncology Clinical Research , Providence, RI , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6472-6658","authenticated-orcid":false,"given":"Adam J","family":"Olszewski","sequence":"additional","affiliation":[{"name":"Department of Medicine, Alpert Medical School of Brown University , Providence, RI , USA"},{"name":"Division of Hematology-Oncology, Rhode Island Hospital , Providence, RI , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2022,3,7]]},"reference":[{"issue":"9873","key":"2022070520265544500_CIT0001","doi-asserted-by":"crossref","first-page":"1203","DOI":"10.1016\/S0140-6736(12)61763-2","article-title":"Bendamustine plus rituximab versus CHOP plus rituximab as first-line treatment for patients with indolent and mantle-cell lymphomas: an open-label, multicentre, randomised, phase 3 non-inferiority trial.","volume":"381","author":"Rummel","year":"2013","journal-title":"Lancet."},{"issue":"6","key":"2022070520265544500_CIT0002","doi-asserted-by":"crossref","first-page":"676","DOI":"10.1200\/JCO.2012.46.2309","article-title":"High-dose vincristine sulfate 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long-term follow-up and biomarker analysis.","volume":"4","author":"Noy","year":"2020","journal-title":"Blood Adv."},{"key":"2022070520265544500_CIT0023","doi-asserted-by":"crossref","first-page":"42","DOI":"10.1182\/blood-2020-135839","article-title":"Mosunetuzumab shows promising efficacy in patients with multiply relapsed follicular lymphoma: updated clinical experience from a phase I dose-escalation trial.","volume":"136","author":"Assouline","year":"2020","journal-title":"Blood"},{"key":"2022070520265544500_CIT0024","doi-asserted-by":"crossref","first-page":"3935","DOI":"10.2147\/CMAR.S267258","article-title":"Chemotherapy-free management of follicular and marginal zone lymphoma.","volume":"13","author":"Ollila","year":"2021","journal-title":"Cancer Manag Res."}],"container-title":["The 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