Phase II Study of MESA Chemotherapy in Patients With Natural Killer/T Cell Lymphoma
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- response criteria for CR(complete remission)by physical examination,lymph nodes masses and bone marrow test.
研究概览
简要总结
Study on the efficacy and safety of MESA chemotherapy for treating NK/T cell lymphoma
详细描述
Extranodal natural killer (NK)/T-cell lymphoma (ENKTL), nasal type, is a distinct and heterogeneous histopathologic subtype of non-Hodgkin lymphoma (NHL), accounting for 5%~10%. The frequency of ENKTL among NHL patients is significantly higher in Asia than in Western countries. Despite radiotherapy and chemotherapy, the prognosis for ENKTL patients is poor, with 5-year median survival time for primary nasal site was 5 years, for non-nasal extranodal sites 6 months. ENKTL is so aggressive and has high mortality rate and till now there is no standard therapy. In recent years SMILE chemotherapy has clinical efficacy and is one of first line therapy for ENKTL. However it is apparent that this regimen is extremely toxic with grade 4 neutropenia especially for Asian patients. On these grounds, new therapy MESA is used for Asian patients with ENKTL in order to achieve good efficacy and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
MESA chemotherapy
Methotrexate etoposide dexamethasone Polyehylene glycol-asparaginase Methotrexate 2g/ m2，IV d1 etoposide 100mg/ m2，VD d2，d3，d4 dexamethasone 20mg/ m2，VD d2，d3，d4，d5 Polyehylene glycol-asparaginase muscular injection 2500IU/ m2, d5
干预措施: MESA chemotherapy (Drug)
MESA chemotherapy
Methotrexate etoposide dexamethasone Polyehylene glycol-asparaginase Methotrexate 2g/ m2，IV d1 etoposide 100mg/ m2，VD d2，d3，d4 dexamethasone 20mg/ m2，VD d2，d3，d4，d5 Polyehylene glycol-asparaginase muscular injection 2500IU/ m2, d5
干预措施: MESA (Drug)
结局指标
主要结局
response criteria for CR(complete remission)by physical examination,lymph nodes masses and bone marrow test.
时间窗: 24 week
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
次要结局
- rate of survival(1 year, 2 years, 3years)
研究者
Xie-qun Chen
Dean of Department of Hematology, Xijing Hosptial
Air Force Military Medical University, China