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

Sun Yat-sen University

Status and phase

Unknown

Phase 2

Conditions

Extranodal NK/T-cell Lymphoma, Nasal Type

Treatments

Drug: Oxaliplatin

Biological: Avastin

Drug: Pegaspargase

Drug: Gemcitabine

Drug: Dexamethasone

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01921790

B2013-017-01

Details and patient eligibility

About

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

Full 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

Enrollment

30 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.