Combination of Mitoxantrone Liposome and Etoposide, Dexamethasone, Pegaspargase and Golidocitinib… (NCT07525466) | Clinical Trial Compass
RecruitingPhase 1/2
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)
China25 participantsStarted 2026-04-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
6-month overall survival (OS) rate
Timeframe: From the date of initiation of MEPL-G as of 6 months after initiation of MEPL-G