Status:
UNKNOWN
Avastin+ GemAOD As First-Line Treatment in NK/T Cell Lymphoma
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Hoffmann-La Roche
Eli Lilly and Company
Conditions:
Extranodal NK/T-cell Lymphoma, Nasal Type
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01921790
Start Date
August 1 2013
End Date
August 1 2020
Last Update
August 22 2013
Active Locations (1)
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1
Department of Medical Oncology, Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060