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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)
Phase 1, PHASE2 trial testing Mitoxantrone liposome in Extranodal NK T Cell Lymphoma in 25 participants. Currently enrolling.
31 March 2028
Quick facts
| Lead sponsor | Beijing Tongren Hospital |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 25 |
| Start date | 1 April 2026 |
| Primary completion | 31 March 2028 |
| Estimated completion | 30 September 2028 |
| Sites | 1 location across China |
Drugs / interventions tested
- Mitoxantrone liposome
- Etoposide (etoposide) — full drug profile →
- Pegaspargase (PEG) Asparaginase — full drug profile →
- methylprednisolone (methylprednisolone) — full drug profile →
- golidocitinib
Conditions studied
- Extranodal NK T Cell Lymphoma — all drugs for Extranodal NK T Cell Lymphoma →
- Hemophagocytic Lymphohistiocytosis (HLH) — all drugs for Hemophagocytic Lymphohistiocytosis (HLH) →
Sponsor
Beijing Tongren Hospital
Who can join
18 and older, any sex, with Extranodal NK T Cell Lymphoma or Hemophagocytic Lymphohistiocytosis (HLH). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07525466
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07525466 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Beijing Tongren Hospital
- Last refreshed: 13 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07525466.
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