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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)

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllBeijing Tongren Hospital
NCT07525466 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Mitoxantrone liposome
  • Etoposide
  • Pegaspargase (PEG) Asparaginase
  • methylprednisolone
  • golidocitinib
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Where

1 site
Beijing Tongren Hospital, Capital Medical University
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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