drugset
drugset / Trial / NCT06953739

A Study Comparing of P-GEMD Regimen Versus P-Gemox Regimen With Untreated Early-Stage NUAT or Advanced-Stage ENKTL.

NCT06953739 ↗

Phase 3 Not yet recruiting 60 enrolled The First Affiliated Hospital with Nanjing Medical University
RandomizedParallel-groupOpen-labelTreatment

Summary

Extranodal natural-killer (NK)/T-cell lymphoma (ENKTL) is an aggressive subtype of non-Hodgkin lymphoma with a poor prognosis. Notably, patients with advanced-stage disease or early-stage non-upper aero-digestive tract (NUAT) involvement frequently develop hemophagocytic lymphohistiocytosis (HLH), necessitating more effective therapeutic interventions. This Multicenter, Randomized Controlled Clinical Study aimed to compare the efficacy and safety of P-GEMD and P-Gemox in the treatment of newly diagnosed early NUAT or advanced-stage ENKTL.

Timeline

Start
2025-05-01
Primary completion
2027-12-31
Completion
2030-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Drug: Mitoxantrone hydrochloride liposome Mitoxantrone hydrochloride liposome (12 mg/m2) on day 1, every 3 weeks; Drug: Pegaspargase Pegaspargase(3750 IU) on day 2, every 3 weeks; Drug: Gemcitabine Gemcitabine (1000 mg/m2) on day 1, every 3 weeks; Drug: Etoposide Etoposide (65 mg/m2) on day 2-4, every 3 weeks. Drug: Dexamethasone Dexamethasone (40 mg/d) will be taken orally from day 1-4, every 3 weeks; Patients \u003e 65 years of age may be adjusted according to the investigator's decision. Unknown 40 mg Oral
Subject Etoposide Small molecule 65 mg/m2 Intravenous
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous
Subject Mitoxantrone hydrochloride liposome Unknown 12 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 130 mg/m2 Intravenous
Subject Pegaspargase Protein / enzyme biologic 2000 iu/kg Intravenous
Subject Pegaspargase Protein / enzyme biologic 2500 iu/kg Intravenous
Subject Pegaspargase Protein / enzyme biologic 3750 iu Intravenous

Indications

mature T-cell and NK-cell non-Hodgkin lymphoma