Clinical Trial: Avastin+ GemAOD As First-Line Treatment in NK/T Cell Lymphoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: An Open-Label, Uncontrolled, Single Centered Phase Ⅱ Study of Avastin Combined With Gemcitabine, Oxaliplatin, Pegaspargase and Dexamethasone (Avastin+ GemAOD) As First-Line Treatment in Patients

Brief Summary: The purpose of this study is to evaluate the efficacy and safety of avastin combined with gemcitabine, oxaliplatin, pegaspargase and dexamethasone(Avastin+ GemAOD) as first-line treatment in patients with untreated natural killer(NK)/T cell lymphoma

Detailed Summary: Recent study showed that vascular endothelial growth factor (VEGF) was associated with a poorer outcome in patients with Non-Hodgkin's Lymphoma,and Avastin impacted on tumor endothelial cells to make standard chemotherapy work better for T cell lymphoma. Many researches on Gemcitabine combined with Oxaliplatin for treatments of recurrent and refractory Non-Hodgkin's lymphoma showed patients could benefit from the combination treatment . Pegaspargase plays an important role for treatment of NK/T cell lymphoma. 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 Avastin combined with gemcitabine, oxaliplatin, pegaspargase and dexamethasone(Avastin+ GemAOD) as first-line treatment in patients with untreated 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) ]
  • The tolerance and the side effects of the treatment [ Time Frame: every 3 weeks,up to completion of treatment(approximately 6 months) ]
    21 days(3 weeks) for one cycle,Toxicity was evaluated every cycle


Original Secondary Outcome: Same as current

Information By: Sun Yat-sen University

Dates:
Date Received: August 3, 2013
Date Started: August 2013
Date Completion: August 2020
Last Updated: August 20, 2013
Last Verified: August 2013