MESA Treatment for NK/T Cell Lymphoma

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

Detailed Description
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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.

Official Title
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Phase II Study of MESA Chemotherapy in Patients With Natural Killer/T Cell Lymphoma

Conditions
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Lymphoma, Extranodal NK-T-Cell

Intervention / Treatment
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* Drug: MESA chemotherapy
* Drug: MESA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MESA chemotherapy<br>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 | Drug: MESA chemotherapy<br>* 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<br>Drug: MESA<br>* Methotrexate etoposide dexamethasone Polyehylene glycol-asparaginase<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MESA, chemotherapy,NK/T cell lymphoma