Clinical Trial: MESA Treatment for NK/T Cell Lymphoma

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

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

Detailed Summary: 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.
Sponsor: Fourth Military Medical University

Current Primary Outcome: response criteria for CR(complete remission)by physical examination,lymph nodes masses and bone marrow test. [ Time Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome: rate of survival [ Time Frame: 1 year, 2 years, 3years ]

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.


Original Secondary Outcome: PFS(Progression-Free-Survival),OS(Overall survival),ORR(overall reactive rate) [ Time Frame: 1 year, 2 years, 3years ]

prognosis assessment by PFS(Progression-Free-Survival). OS(Overall survival)and ORR(overall reactive rate)at 1 year,2 years,3 years after induction therapies and follow up therapies.


Information By: Fourth Military Medical University

Dates:
Date Received: August 16, 2013
Date Started: January 2013
Date Completion: January 2015
Last Updated: December 21, 2013
Last Verified: December 2013