MEPL-G combination therapy for NK/T‑cell lymphoma with 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
This trial will test whether the MEPL-G drug combination (liposomal mitoxantrone, etoposide, pegaspargase, methylprednisolone, and golidocitinib) can control both the lymphoma and the life‑threatening HLH inflammation in adults with NK/T‑cell lymphoma–associated HLH.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beijing Tongren Hospital Academic / other |
| Drugs / interventions | Golidocitinib, chemotherapy |
| Locations | 1 site (Beijing) |
| Trial ID | NCT07525466 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed extranodal NK/T‑cell lymphoma who meet HLH‑2004 diagnostic criteria and who meet cardiac, infection, and viral hepatitis safety requirements are the intended candidates.
Not a fit: Patients with significant cardiac dysfunction (NYHA ≥ II or LVEF <50%), uncontrolled infections, pregnancy or breastfeeding, or certain concurrent malignancies are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, this regimen could rapidly control both the lymphoma and the fatal HLH cytokine storm, improving short‑term survival and enabling patients to reach longer‑term therapies.
How similar studies have performed: Components such as golidocitinib and pegaspargase have shown anti‑NKTCL or anti‑HLH activity in preclinical or early clinical work, but the full MEPL‑G combination is novel and not yet validated in large trials.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.