NCT04405375

GPED Regimen for Relapsed/Refractory or Advanced ENKTCL

Gemcitabine, Pegaspargase, Etoposide, and Dexamethasone (GPED) for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma : a Single Arm,Open-lable,Phase II Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Beijing Tongren Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of gemcitabine, pegaspargase, etoposide, and dexamethasone (GPED) in the treatment of Relapsed/Refractory or advanced NK/T-cell lymphoma patients (ENKTCL).

Detailed description

Pegaspargase is the cornor stone for the treatment of ENKTCL, and gemcitabine has been shown to be active in ENKTCL. For several patients with relapsed/refractory or advance ENKTCL, hemophagocytic sysdrome (HPS) occurs, and the prognosis is very poor. Studies have found that etoposide and dexamethasone may be effective in controlling HPS. Thus, this study aims to evaluate the role of gemcitabine, pegaspargase, etoposide, and dexamethasone (GPED) in the treatment of relapsed/refractory or advance ENKTCL, wishing to improve the prognosis for these patients.

Conditions

• Extranodal NK/T-cell Lymphoma, Nasal Type

Interventions

Type	Name	Description
DRUG	gemcitabin	1.25g/㎡ d1, repeated every 21 days
DRUG	Pegaspargase	2500IU/㎡ d1, total dose=\<3750IU, repeated every 21 days
DRUG	Etoposide	75mg/㎡ d1-3, repeated every 21 days
DRUG	Dexamethasone	20mg d1-4

Timeline

• Start date: 2020-03-21
• Primary completion: 2023-04-30
• Completion: 2023-04-30
• First posted: 2020-05-28
• Last updated: 2020-05-28

Locations

1 site across 1 country: China