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

Phase 2

• Conditions: Extranodal NK/T-cell Lymphoma, Nasal Type
• Interventions: Biological: Avastin; Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Pegaspargase; Drug: Dexamethasone

• Registration Number: NCT01921790
• Lead Sponsor: Sun Yat-sen University

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 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

Study Timeline

• Status Verified: 2013-08
• Study Start: 2013-08
• Study First Submitted: 2013-08-03
• Study First Submitted QC: 2013-08-12
• Study First Posted: 2013-08-13
• Last Update Submitted: 2013-08-20
• Last Update Posted: 2013-08-22
• Primary Completion: 2015-08
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Histologic diagnosis of NK/T Cell Lymphoma;
• Age:18-80 years;
• Eastern Cooperative Oncology Group (ECOG) status 0-3, Estimated survival time > 3 months;
• Normal haematological, liver and renal function (WBC count≥4×109/L, Hemoglobin≥100g/L, platelet count≥100×109/L, bilirubin<1.5×ULN, Alanine transaminase (ALT) or Aspartate Aminotransferase (AST)<2.5×ULN, serum creatinine<1.5×ULN), normal coagulation function and cardiac function;
• Appreciable and measurable lesions ;
• No history of other malignancies;
• No previous treatments including chemotherapy, radiotherapy, targeted therapy or stem cell transplantation;
• No other serious diseases which conflict with the treatment in the present trial;
• No concurrent treatments that conflict with the treatments in the present trial(including steroid drugs);
• Voluntary participation and signed the informed consent.

Exclusion Criteria

• The patients had the conditions below: clinically significant ventricular tachycardia (VT), atrial fibrillation (AF), heart block, myocardial infarction (MI), congestive heart failure (CHF), symptomatic coronary artery heart disease requiring medication;
• The patients suffered from organ transplant
• The patients participated in other clinical trials within the 30 days before enrollment or who are participating in other clinical studies;
• The patients with active bleeding or new thrombotic disease, who are taking anticoagulant drugs or with a history of bleeding tendencies;
• The patients suffered before surgery less than four weeks, or after less than six weeks;
• The patients with major vascular invasion;
• The patients with abnormal liver function (total bilirubin> 1.5 times the normal value, ALT / AST> 2.5 times normal), abnormal renal function (serum creatinine> 1.5 times normal), blood abnormalities (absolute neutrophil count <1.5 × 109 / L, platelets <80 × 109 / L, hemoglobin <90g /L) ;
• The patients with moderate to severe proteinuria;
• Severe hypertension,BP≥160/100mmHg;
• The patients with mentally ill / unable to obtain informed consent;
• The patients with drug addiction, alcohol abuse which affects the long-term evaluation of test results;
• The patients in pregnancy, lactation and women of childbearing age who do not want to take contraceptive measures subjects;
• Clinical and laboratory support brain metastases;
• The patients with a history of allergy to test drug;
• The patients not suitable to participate in the investigator judged by researchers.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Avastin+ GemAOD	Avastin	Avastin+ GemAOD means Avastin Combined With Gemcitabine, Oxaliplatin, Pegaspargase and Dexamethasone
Avastin+ GemAOD	Dexamethasone	Avastin+ GemAOD means Avastin Combined With Gemcitabine, Oxaliplatin, Pegaspargase and Dexamethasone
Avastin+ GemAOD	Gemcitabine	Avastin+ GemAOD means Avastin Combined With Gemcitabine, Oxaliplatin, Pegaspargase and Dexamethasone
Avastin+ GemAOD	Oxaliplatin	Avastin+ GemAOD means Avastin Combined With Gemcitabine, Oxaliplatin, Pegaspargase and Dexamethasone
Avastin+ GemAOD	Pegaspargase	Avastin+ GemAOD means Avastin Combined With Gemcitabine, Oxaliplatin, Pegaspargase and Dexamethasone

Primary Outcome Measures

Name	Time	Method
Overall Response Rate(ORR)	every 6 weeks,up to completion of treatment(approximately 6 months)	21 days(3 weeks) for one cycle,Efficacy was evaluated every two cycles

Secondary Outcome Measures

Name	Time	Method
Progress Free Survival(PFS)	up to end of follow-up-phase (approximately 5 years)
Overall Survival(OS)	up to the date of death (approximately 5 years)
The tolerance and the side effects of the treatment	every 3 weeks,up to completion of treatment(approximately 6 months)	21 days(3 weeks) for one cycle,Toxicity was evaluated every cycle

Trial Locations

Locations (1)

Department of Medical Oncology, Sun Yat-Sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China