Carrie van der Weyden, Mathias Bressel, Amit Khot, Henry Miles Prince, Michael Dickinson
{"title":"Brentuximab Vedotin和来那度胺联合治疗复发或难治性t细胞淋巴瘤的耐受性和最佳剂量评估：一项单中心1期剂量递增研究的结果","authors":"Carrie van der Weyden, Mathias Bressel, Amit Khot, Henry Miles Prince, Michael Dickinson","doi":"10.1002/jha2.70033","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Objective</h3>\n \n <p>We report the results of a pilot study investigating the combination of brentuximab vedotin (BV) and lenalidomide in patients with relapsed/ refractory T-cell lymphoma.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>A dose escalation study design was utilized. Primary and secondary endpoints included maximum tolerated dose (MTD), adverse events, and response rates.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>Six patients were treated with BV and two dose levels of lenalidomide, in 21-day cycles. The protocol-determined MTD was BV 1.8 mg/kg and lenalidomide 25 mg, however, all patients required subsequent dose reductions with ongoing treatment. The most common adverse event was peripheral neuropathy in four of six patients. Two patients achieved complete responses and three achieved partial responses.</p>\n </section>\n \n <section>\n \n <h3> Discussion:</h3>\n \n <p>The combination is deliverable with dose attenuation. Further study is needed to define clinical benefit.</p>\n </section>\n \n <section>\n \n <h3> Clinical Trial Registration</h3>\n \n <p>This trial was registered on ClinicalTrials.gov (NCT number 03302728).</p>\n </section>\n </div>","PeriodicalId":72883,"journal":{"name":"EJHaem","volume":"6 3","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jha2.70033","citationCount":"0","resultStr":"{\"title\":\"Assessment of the Tolerability and Optimal Dosing of the Combination of Brentuximab Vedotin and Lenalidomide in Patients With Relapsed or Refractory T-cell Lymphoma: Results of a Single-centre Phase 1 Dose-escalation Study\",\"authors\":\"Carrie van der Weyden, Mathias Bressel, Amit Khot, Henry Miles Prince, Michael Dickinson\",\"doi\":\"10.1002/jha2.70033\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Objective</h3>\\n \\n <p>We report the results of a pilot study investigating the combination of brentuximab vedotin (BV) and lenalidomide in patients with relapsed/ refractory T-cell lymphoma.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>A dose escalation study design was utilized. Primary and secondary endpoints included maximum tolerated dose (MTD), adverse events, and response rates.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>Six patients were treated with BV and two dose levels of lenalidomide, in 21-day cycles. The protocol-determined MTD was BV 1.8 mg/kg and lenalidomide 25 mg, however, all patients required subsequent dose reductions with ongoing treatment. The most common adverse event was peripheral neuropathy in four of six patients. Two patients achieved complete responses and three achieved partial responses.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Discussion:</h3>\\n \\n <p>The combination is deliverable with dose attenuation. Further study is needed to define clinical benefit.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Clinical Trial Registration</h3>\\n \\n <p>This trial was registered on ClinicalTrials.gov (NCT number 03302728).</p>\\n </section>\\n </div>\",\"PeriodicalId\":72883,\"journal\":{\"name\":\"EJHaem\",\"volume\":\"6 3\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-05-13\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jha2.70033\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"EJHaem\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1002/jha2.70033\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"EJHaem","FirstCategoryId":"1085","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/jha2.70033","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Assessment of the Tolerability and Optimal Dosing of the Combination of Brentuximab Vedotin and Lenalidomide in Patients With Relapsed or Refractory T-cell Lymphoma: Results of a Single-centre Phase 1 Dose-escalation Study
Objective
We report the results of a pilot study investigating the combination of brentuximab vedotin (BV) and lenalidomide in patients with relapsed/ refractory T-cell lymphoma.
Methods
A dose escalation study design was utilized. Primary and secondary endpoints included maximum tolerated dose (MTD), adverse events, and response rates.
Results
Six patients were treated with BV and two dose levels of lenalidomide, in 21-day cycles. The protocol-determined MTD was BV 1.8 mg/kg and lenalidomide 25 mg, however, all patients required subsequent dose reductions with ongoing treatment. The most common adverse event was peripheral neuropathy in four of six patients. Two patients achieved complete responses and three achieved partial responses.
Discussion:
The combination is deliverable with dose attenuation. Further study is needed to define clinical benefit.
Clinical Trial Registration
This trial was registered on ClinicalTrials.gov (NCT number 03302728).
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
