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

EJHaem Pub Date : 2025-05-13 DOI:10.1002/jha2.70033

Carrie van der Weyden, Mathias Bressel, Amit Khot, Henry Miles Prince, Michael Dickinson

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Abstract

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).

查看原文本刊更多论文

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

我们报告了一项关于brentuximab vedotin （BV）和来那度胺联合治疗复发/难治性t细胞淋巴瘤的初步研究结果。方法采用剂量递增试验设计。主要和次要终点包括最大耐受剂量（MTD）、不良事件和反应率。结果6例患者采用来那度胺治疗BV，疗程为21 d。方案确定的MTD为BV 1.8 mg/kg，来那度胺25 mg，然而，所有患者都需要在持续治疗的同时减少剂量。最常见的不良事件是周围神经病变，6例患者中有4例。2例患者达到完全缓解，3例达到部分缓解。讨论：该组合具有剂量衰减。需要进一步的研究来确定临床益处。该试验已在ClinicalTrials.gov上注册（NCT号03302728）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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EJHaem

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