Lymphoma, Extranodal NK-T-Cell Clinical Trial
— MTNOfficial title:
Phase II Study of MESA Chemotherapy in Patients With Natural Killer/T Cell Lymphoma
Study on the efficacy and safety of MESA chemotherapy for treating NK/T cell lymphoma
Status | Recruiting |
Enrollment | 100 |
Est. completion date | January 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 15 Years to 60 Years |
Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Department of Hemaology, Xi jing Hospital,The Fourth Military Medical University | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
Fourth Military Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | response criteria for CR(complete remission)by physical examination,lymph nodes masses and bone marrow test. | After 6 cycle of MESA treatment,response assessments for CR,PR(partial remission) and NR(no remission) should include appropriate imaging studies(CT,MRI and PET-CT) based on the type of study performed at initial workup, endoscopy with visual inspection, repeat biopsies and measurement of EBV DNA | 24 week | Yes |
Secondary | rate of survival | prognosis assessment by rates of survival including PFS(Progression-Free-Survival) and OS(Overall survival)at 1 year,2 years,3 years after induction therapies and follow up therapies. | 1 year, 2 years, 3years | Yes |
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