NCT01991158

GAD-M Regimen As First-Line Treatment in Untreated Extranodal NK/T Cell Lymphoma

An Open, Single-center, Phase II Clinical Trial for Treatment of Untreated Extranodal NK/T Cell Lymphoma With High Dose of Methotrexate in Combination With Gemcitabine, Pegaspargase and Dexamethasone (GAD-M Regimen)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of High dose of Methotrexate combined with gemcitabine, pegaspargase and dexamethasone (GAD-M regimen) as first-line treatment in patients with de novo extranodal NK/T cell lymphoma.

Detailed description

Studies have shown that effects of P glycoprotein mediated chemotherapy resistance reduce the therapeutic efficacy of anthracycline-based chemotherapy of NK/T cell lymphoma, and agents like pegaspargase and large doses of Methotrexate is not affected by the P glycoprotein. A number of reports suggest that gemcitabine combined with other chemotherapy drugs has good application prospect in the treatment of lymphomas. Dexamethasone is used in combination with other agents for the treatment of lymphomas which may be implicated in the development or growth of some cancers. So we explored to evaluate the efficacy and safety of High dose of methotrexate combined with gemcitabine, pegaspargase and dexamethasone (GAD-M regimen) as first-line treatment in patients with untreated extranodal NK/T cell lymphoma.

Conditions

• Extranodal NK/T-cell Lymphoma, Nasal Type

Interventions

Type	Name	Description
DRUG	High dose of methotrexate	Methotrexate 3.0g/Kg, intravenous drip D1
DRUG	Gemcitabine	Gemcitabine 1g/m2 intravenous drip D1,D8
DRUG	Pegaspargase	Pegaspargase 2500U/m2 intramuscular injection (IM) D1
DRUG	Dexamethasone	Dexamethasone 20mg/d intravenous drip D1, po D2-3

Timeline

• Start date: 2013-11-01
• Primary completion: 2016-12-01
• Completion: 2020-11-01
• First posted: 2013-11-25
• Last updated: 2016-06-14

Locations

1 site across 1 country: China