Liposomal mitoxantrone monotherapy in patients with relapsed or refractory mature T-cell and natural killer-cell neoplasms: A phase 2, multicenter, open-label, single-arm trial.

ABSTRACT:

Introduction

The prognosis of relapsed or refractory mature T- and natural killer (NK)-cell lymphoma remains dismal. Novel agents are urgently needed to improve the outcomes for this population.

Methods

In this phase 2, multicenter, open-label, single-arm study (NCT03776279), the authors report the efficacy and safety of liposomal mitoxantrone (Lipo-MIT) monotherapy in patients with relapsed or refractory mature T- and NK-cell lymphoma. Lipo-MIT was administered intravenously at 20 mg/m² once every 4 weeks. The primary end points were the objective response rate (ORR) determined by the independent review committee (IRC) and investigators. Secondary end points included duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety.

SUBMITTER: Gao Y 

PROVIDER: S-EPMC11695808 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature