MEPL-G combination therapy for NK/T‑cell lymphoma with HLH

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 1/2, open‑label trial combining a selective JAK1 inhibitor (golidocitinib) with liposomal mitoxantrone and established HLH-directed agents (etoposide, pegaspargase, methylprednisolone) to treat adults with extranodal NK/T‑cell lymphoma complicated by HLH. The approach pairs targeted inhibition of JAK/STAT‑driven inflammation with cytotoxic and anti‑HLH agents to try to control both tumor burden and cytokine storm. Primary objectives include safety, tolerability, dose finding and preliminary efficacy endpoints such as response rate and short‑term survival. Patients receive treatment at Beijing Tongren Hospital with close monitoring of cardiac function, infections, and viral hepatitis markers.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Tongren Hospital, Capital Medical University
  Beijing, China Recruiting

Study contacts

• Principal investigator: Liang Wang — Beijing Tongren Hospital
• Study coordinator: Liang Wang, M.D.
• Email: wangliangtrhos@126.com
• Phone: +861058266633

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.