NCT01921790

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

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 With Untreated NK/T Cell Lymphoma

• 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 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 description

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

Conditions

• Extranodal NK/T-cell Lymphoma, Nasal Type

Interventions

Type	Name	Description
BIOLOGICAL	Avastin	Avastin 7.5mg/Kg, intravenous drip D1
DRUG	Gemcitabine	Gemcitabine 1g/m2 intravenous drip D1,D8
DRUG	Oxaliplatin	Oxaliplatin 130mg/m2 intravenous drip D1
DRUG	Pegaspargase	Pegaspargase 2500U/m2 intramuscular injection (IM) D1
DRUG	Dexamethasone	Dexamethasone 20mg/d intravenous drip D1, po D2-3

Timeline

• Start date: 2013-08-01
• Primary completion: 2015-08-01
• Completion: 2020-08-01
• First posted: 2013-08-13
• Last updated: 2013-08-22

Locations

1 site across 1 country: China