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Pegaspargase Combined With Gemcitabine, Etoposide, Liposomal Mitoxantrone Hydrochloride and Dexamethasone (P-GEMD) in the Treatment of Untreated Early Non-upper Respiratory Tract or Advanced Extranodal NK/T-cell Lymphoma

NCT05774028 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-03-17

No results posted yet for this study

Summary

NK/T-cell lymphoma (NKTCL) is one of the most common types of extranodal lymphoma.NKTCL originates from NK cells and T lymphocytes and is highly invasive. There is a lack of efficient and specific treatment methods in clinical practice, and the prognosis is poor. The molecular heterogeneity of NKTCL is strong, and molecular typing and risk stratification are of great significance for understanding the disease and improving the curative effect.Based on the preclinical studies of mitoxantrone liposomes, the investigators put forward a hypothesis: mitoxantrone liposome injection combined with pegaspargase, gemcitabine, and dexamethasone (P-GEMD) in the treatment of early non-upper respiratory digestive tract It is safe and can improve the therapeutic effect in patients with gastric or advanced extranodal NK/T cell lymphoma.

Conditions

  • NK-T-Cell Lymphoma, Extranodal

Interventions

DRUG

Pegaspargase Combined With Gemcitabine, Etoposide, Liposomal Mitoxantrone Hydrochloride and Dexamethasone (P-GEMD) regimen

P-GEMD regimen (Every 3 weeks as a cycle, a total of 6 cycles) : Pegaspargase 3750 IU, d2; Gemcitabine 1000mg/m2, d1; Etoposide 65mg/m2, d2-d4; Mitoxantrone hydrochloride liposome 12mg/m2, d1; Dexamethasone 40mg/d, d1- d4.

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-30
Primary Completion
2024-04-30
Completion
2025-04-30

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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 NCT05774028 on ClinicalTrials.gov