MESA Treatment for NK/T Cell Lymphoma

• Status: Unknown status
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Study on the efficacy and safety of MESA chemotherapy for treating NK/T cell lymphoma

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

Details

• Lead Sponsor: Air Force Military Medical University, China; Fourth Military Medical University
• Treatments: Asparaginase; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Etoposide; Methotrexate

Criteria

Inclusion Criteria:

• Pathological diagnosis is NK/T cell lymphoma；

• At least one objective evaluation ( measurable ) lesions

• Age 15 ~ 60 years old, men and women are not limited

• ECOG(Eastern Cooperative Oncology Group）performance status 0~3，Expected to survive more than 3 months;

• Heart, kidney function in the normal range

• Liver function: transminase< 2 times the normal value

• pregnancy tests of women childbearing age must be negative; Men and women agree to use effective contraception during the treatment and the following year

• Before the test sign the written informed consent

Exclusion Criteria:

• The early use of methotrexate or/and L-asparaginase;

• Pregnant or nursing, psychiatric patients complicated with malignant tumor

• At the same time the application of other trial drug, drug contraindications exist in research;

• Serious infection or metabolic diseases

• Liver dysfunction, serum direct bilirubin, indirect bilirubin, transaminase 2 times higher than normal; serum total protein or albumin below normal;

• Renal insufficiency, creatinine clearance rate was 2 times higher than normal, especially the creatinine clearance rate is less than 30ml/min;

• Before entering the group, blood: White blood cell< 3×10E9/L; absolute neutrophil count<1.5×10E9/L; platelet<100×10E9/L ( bone marrow is not violated ); platelet count <75×10E9/L ( bone marrow invasion ); hemoglobin<100g/L.

• In the 6 months before entering the group, patients with uncontrolled or serious cardiovascular diseases, including myocardial infarction, III-IV class heart failure, uncontrolled angina or clinically significant pericardial disease, and diabetes and phlebitis;

• HIV antibody positive, HBsAg positive after antiviral HBV(hepatitis B virus) DNA titer in 104copies/ml the following groups. HIV antibody positive, HBsAg+ and DNA titer in 104copies/ml after antiviral HBV therapy

• Coagulation abnormalities.