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)
| NCT ID | NCT07525466 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Beijing Tongren Hospital |
| Condition | Extranodal NK T Cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 25 participants in total. It began in 2026-04-01 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Liang Wang
PRINCIPAL INVESTIGATOR
Beijing Tongren Hospital
Frequently Asked Questions
Who can join the NCT07525466 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Extranodal NK T Cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07525466 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07525466 currently recruiting?
Yes, NCT07525466 is actively recruiting participants. Contact the research team at wangliangtrhos@126.com for enrollment information.
Where is the NCT07525466 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07525466 clinical trial?
NCT07525466 is sponsored by Beijing Tongren Hospital. The principal investigator is Liang Wang at Beijing Tongren Hospital. The trial plans to enroll 25 participants.