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NCT05527275

A Phase I/II Study of Mitoxantrone Liposome Combined With Chidamide in Relapsed/Refractory Peripheral T-cell Lymphoma

Status unknown Phase 1, PHASE2 Last updated 2 September 2022
What this trial tests

Phase 1, PHASE2 trial testing Mitoxantrone liposome combine with Chidamide in Relapsed and Refractory Peripheral T-cell Lymphoma in 78 participants. Status unknown.

Timeline
1 October 2022
Primary endpoint
1 September 2024
1 December 2024

Quick facts

Lead sponsorSun Yat-sen University
PhasePhase 1, PHASE2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment78
Start date1 October 2022
Primary completion1 September 2024
Estimated completion1 December 2024
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Sun Yat-sen University

Who can join

Adults 18 to 70, any sex, with Relapsed and Refractory Peripheral T-cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Peripheral T-cell lymphoma (PTCL) is a highly heterogeneous group of aggressive non-Hodgkin lymphoma (NHL) originating from mature thymus T cells.Mitoxantrone Hydrochloride Liposome Injection can accelerate the entry of mitoxantrone into cells, reduce the efflux of mitoxantrone, ensure the concentration of intracellular drugs, reverse the drug resistance mechanism, and enhance anti-tumor activity.We will explore the dose-limiting toxicity (DLT) of Mitoxantrone Hydrochloride Liposome Injection combined with Chidamide in the treatment of relapsed or refractory peripheral T-cell lymphoma, estimate the maximum tolerated dose (MTD) of the combination, and determine the phase II recommended dose RP2D.In the phase II study, we will evaluate the safety and efficacy of the combination regimen.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Case report: Good response to CMOP regimen containing mitoxantrone hydrochloride liposome (PLM60) as induction chemotherapy in patients with angioimmunoblastic T-cell lymphoma.
    Liang L, Jiang M. · · 2024 · cited 1× · PMID 38357199 · DOI 10.3389/fonc.2024.1331154
  2. Publication Only
    · 2025

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