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 · tracked via the Priya Life Science China tracker

Sponsor

Beijing Tongren Hospital

Phase

Phase 1/2

Started

2026-04-01

Last updated

2026-04-13

Condition(s) studied

Extranodal NK T Cell LymphomaHemophagocytic Lymphohistiocytosis (HLH)

Investigational drug(s) / intervention(s)

Mitoxantrone liposomeEtoposide →Pegaspargase (PEG) Asparaginasemethylprednisolone →golidocitinib →

Mitoxantrone liposome: In the Phase Ib part, 3 patients will be enrolled at the starting dose of liposomal mitoxantrone: 18 mg/m²/d on day 1, every 3 weeks (q3w). If no DLT occurs, the recommended phase 2 dose (RP2D) will be 18 mg/m²/d on day 1 q3w. If DLT occurs, the dose will be de-escalated sequentially (18→16→14→12 mg/m²/d on day 1 q3w).

Etoposide: 100mg/m²/d，d1、d8，q3w

Pegaspargase (PEG) Asparaginase: 2000IU/m²/d，d5，q3w

methylprednisolone: 15mg/kg/d，d1-3 7.5mg/kg/d，d4-7 1mg/kg/d d8-14 10mg/d，d15-21

golidocitinib: 150mg/d，d1-d21，q3w

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Histologically confirmed extranodal NK/T-cell lymphoma. * Meeting the HLH-2004 diagnostic criteria (≥ 5 criteria). * Age ≥ 18 years, regardless of gender. * Negative HIV antigen or antibody. * Left ventricular ejection fraction (LVEF) ≥ 50% on cardiac echocardiography. * No active visceral bleeding (e.g., gastrointestinal, pulmonary, cerebral). * No uncontrolled infection (e.g., pulmonary infection, intestinal infection). * Negative HCV antibody; or positive HCV antibody with negative HCV RNA. * Negative HBsAg and negative HBcAb. If either is positive, peripheral blood HBV DNA load must be \< 1×10³ copies/mL to be eligible. * Signed written informed consent and ability to understand and comply with all study requirements. Exclusion Criteria: * New York Heart Association (NYHA) cardiac function class ≥ II; * Female patients who are pregnant or breastfeeding; * Known hypersensitivity to any of the study drugs; * Presence of other concurrent malignancies (except non-melanoma skin cancer); * Concurrent central nervous system lymphoma infiltration; * Severe psychiatric disorders or inability to comply with follow-up; * Severe renal dysfunction (glomerular filtration rate \< 15 mL/min); * Severe liver cirrhosis (MELD score \> 20); * History of acute or chronic pancreatitis; * Simultaneous participation in another clinical trial.

Primary outcome measure(s)

6-month overall survival (OS) rate — From the date of initiation of MEPL-G as of 6 months after initiation of MEPL-G
OS was defined from the date of initiation of MEPL-G to the date fo death.

Trial sites (1)

Facility	City	Region	Status
Beijing Tongren Hospital, Capital Medical University	Beijing	China	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07525466 on ClinicalTrials.gov ↗ ← All trials in China