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

• Status: Unknown status
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborators: Eli Lilly and Company; Hoffmann-La Roche
• Treatments: Asparaginase; BB 1101; Bevacizumab; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Gemcitabine; Oxaliplatin; Pegaspargase

Criteria

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.