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

NCT06953739 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-05-01

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Principal Investigators

  • Wei Xu · he First Affiliated Hospital with Nanjing Medical University, Nanjing, China

  • Jinhua Liang · he First Affiliated Hospital with Nanjing Medical University, Nanjing, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06953739 on ClinicalTrials.gov