Pralatrexate injection combined with oral leucovorin for mucositis management in PTCL/CTCL treatment: a multicenter phase 2 trial

{"title":"Pralatrexate injection combined with oral leucovorin for mucositis management in PTCL/CTCL treatment: a multicenter phase 2 trial","authors":"Swaminathan P. Iyer ,&nbsp;Shaker Dakhil ,&nbsp;Michi M. Shinohara ,&nbsp;Jasmine Zain ,&nbsp;Mark Acosta ,&nbsp;Francine Foss","doi":"10.1016/j.bneo.2024.100055","DOIUrl":null,"url":null,"abstract":"<div><h3>Abstract</h3><div>Pralatrexate (Folotyn) is an antifolate indicated for the treatment of relapsed/refractory peripheral T-cell lymphoma (PTCL), and although durable clinical benefit has been demonstrated, oral and gastrointestinal mucositis and/or skin reactions are frequent toxicity complications associated with pralatrexate treatment. Leucovorin (d,l-folinic acid) administration has been used as a standard rescue for patients receiving high-dose methotrexate therapy and has recently been studied in patients with PTCL and cutaneous T-cell lymphoma receiving pralatrexate. We describe results from a multicenter, phase 2, single-arm, open-label trial, conducted with the primary objective of evaluating the effect of leucovorin in preventing or reducing the incidence of grade 2 or higher oral mucositis associated with pralatrexate treatment in cycle 1. Patients were administered pralatrexate, 30 mg/m² as an IV push, once weekly for 6 weeks in each cycle, followed by a week of rest (no treatment). Leucovorin 25 mg tablets were administered 3 times daily for 2 days (a total of 6 doses [150 mg cumulative weekly dose]), initiated 24 hours (±2 hours) after each pralatrexate dose. The evaluable population included 34 patients, with a mean age of 63.7 years and 60% males, of whom 2 (5.9%) developed grade 2 oral mucositis during the study period (<em>P</em> &lt; .0001) and there were no reports of grade 3 or higher oral mucositis. Dose modifications, including omissions, delays, or reductions, due to oral mucositis were limited to 1 patient. Coadministration of leucovorin resulted in a significant reduction in mucositis and can be considered a prophylactic therapy in patients receiving pralatrexate treatment. This trial was registered at <span><span>www.clinicaltrials.gov</span><svg><path></path></svg></span> as #<span><span>NCT02106650</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":100189,"journal":{"name":"Blood Neoplasia","volume":"2 1","pages":"Article 100055"},"PeriodicalIF":0.0000,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Blood Neoplasia","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2950328024000554","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}