Study on the efficacy and safety of MESA chemotherapy for treating NK/T cell lymphoma
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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
Methotrexate etoposide dexamethasone Polyehylene glycol-asparaginase
Department of Hemaology, Xi jing Hospital,The Fourth Military Medical University
Xi'an, Shaanxi, China
RECRUITINGresponse 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
Time frame: 24 week
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.
Time frame: 1 year, 2 years, 3years
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