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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: 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, Pe

Brief 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 Summary: 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.
Sponsor: Sun Yat-sen University

Current Primary Outcome: Overall Response Rate (ORR) [ Time Frame: every 6 weeks, up to completion of treatment (approximately 6 months) ]

21 days (3 weeks) for one cycle, Efficacy was evaluated every two cycles


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Progress Free Survival (PFS) [ Time Frame: up to end of follow-up-phase (approximately 5 years) ]
  • Overall Survival (OS) [ Time Frame: up to the date of death (approximately 5 years) ]


Original Secondary Outcome: Same as current

Information By: Sun Yat-sen University

Dates:
Date Received: November 7, 2013
Date Started: November 2013
Date Completion: November 2020
Last Updated: June 11, 2016
Last Verified: June 2016