drugset / Trial / NCT07525466

Combination of Mitoxantrone Liposome and Etoposide, Dexamethasone, Pegaspargase and Golidocitinib (MEPL-G) in the Treatment of NK/T-cell Lymphoma Associated Hemophagocytic Lymphohistiocytosis (NKTCL-HLH)

NCT07525466

Phase 1/2 Recruiting 25 enrolled Beijing Tongren Hospital
NaSingle-groupOpen-labelTreatment

Summary

Extranodal NK/T-cell lymphoma (NKTCL) is an aggressive EBV-associated lymphoma with poor prognosis, highly prevalent in China. Early-stage NKTCL achieves favorable long-term survival, while advanced disease shows dismal outcomes with no standard therapy. Notably, 10%-20% of patients develop secondary hemophagocytic lymphohistiocytosis (NKTCL-HLH), a life-threatening complication with median survival \<2 months and mortality over 90%. Current treatments fail to simultaneously control lymphoma and hyperinflammation, with poor tolerance and high resistance. The JAK/STAT pathway drives EBV-induced inflammation and tumor progression. Golidocitinib, a selective JAK1 inhibitor, demonstrates potent anti-NKTCL activity and rapid inflammation control. Liposomal mitoxantrone offers targeted efficacy with lower toxicity, while etoposide, methylprednisolone, and pegaspargase provide synergistic anti-tumor and anti-HLH effects. This study proposes the novel MEPL-G regimen (liposomal mitoxantrone, etoposide, methylprednisolone, pegaspargase, golidocitinib) for NKTCL-HLH. By targeting both HLH and NKTCL, this combination aims to achieve rapid disease control, improve tolerance, and prolong survival, addressing the unmet critical clinical need for this high-risk population.

Timeline

Start
2026-04-01
Primary completion
2028-03-31
Completion
2028-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Etoposide Small molecule 100 mg/m2
Subject Golidocitinib Small molecule 150 mg
Subject Methylprednisolone Other / unclassified 10 mg
Subject Mitoxantrone Small molecule 12 mg/m2
Subject Mitoxantrone Small molecule 14 mg/m2
Subject Mitoxantrone Small molecule 16 mg/m2
Subject Mitoxantrone Small molecule 18 mg/m2
Subject Pegaspargase Protein / enzyme biologic 2000 unknown