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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

May 1, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2030

Conditions
NK-T-Cell Lymphoma, Extranodal
Interventions
DRUG

P-GEMD

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 \> 65 years of age may be adjusted according to the investigator's decision.

DRUG

P-Gemox

Drug: Pegaspargase Pegaspargase(2000-2500 IU/m2) on day 1, every 3 weeks; Drug: Gemcitabine Gemcitabine (1000 mg/m2) on day 1 and day 8, every 3 weeks; Drug: Oxaliplatin Oxaliplatin (130mg/m2) on day 1, every 3 weeks; Patients \> 65 years of age may be adjusted according to the investigator's decision.

All Listed Sponsors
lead

The First Affiliated Hospital with Nanjing Medical University

OTHER