RecruitingPhase 1Phase 2NCT07525466

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)

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): a Prospective, Multi-center, Single Arm, Phase Ib/II Clinical Trial


Sponsor

Beijing Tongren Hospital

Enrollment

25 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria10

  • 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 Criteria10

  • 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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Interventions

DRUGMitoxantrone 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).

DRUGEtoposide

100mg/m²/d,d1、d8,q3w

DRUGPegaspargase (PEG) Asparaginase

2000IU/m²/d,d5,q3w

DRUGmethylprednisolone

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

DRUGgolidocitinib

150mg/d,d1-d21,q3w


Locations(1)

Beijing Tongren Hospital, Capital Medical University

Beijing, China

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NCT07525466


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