Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extranodal NK T Cell Lymphoma | Nasal Type Extranodal NK/T-Cell Lymphoma | ALIAS | 0.90 |
| Hemophagocytic Lymphohistiocytosis (HLH) | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Etoposide | Drug | Etoposide | ALIAS |
| golidocitinib | Drug | — | UNRESOLVED |
| methylprednisolone | Drug | — | UNRESOLVED |
| Mitoxantrone liposome | Drug | — | UNRESOLVED |
| Pegaspargase (PEG) Asparaginase | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MEPL-G group
- description
- All enrolled patients may initiate induction therapy with the MEPL-G regimen after completing baseline imaging and laboratory examinations. The detailed administration is as follows: Doses of etoposide, golidocitinib, pegaspargase, and methylprednisolone are fixed. The optimal dose of liposomal mitoxantrone will be determined based on dose-limiting toxicity (DLT). 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. One cycle is 3 weeks, for a total of 6 cycles. Patients achieving CR or PR after 2 cycles may be referred for allogeneic hematopoietic stem cell transplantation. Patients with CR or PR after 2 cycles who are ineligible for transplantation may continue MEPL-G for a total of 6 cycles, followed by maintenance therapy with golidocitinib monotherapy
- interventionNames
- Drug: Mitoxantrone liposome
- Drug: Etoposide
- Drug: Pegaspargase (PEG) Asparaginase
- Drug: methylprednisolone
- Drug: golidocitinib
Primary outcomes (1)
- measure
- 6-month overall survival (OS) rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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