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