Clinical trial NCT01933282: MESA Treatment for NK/T Cell Lymphoma
Official title: Phase II Study of MESA Chemotherapy in Patients With Natural Killer/T Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lymphoma, Extranodal NK-T-Cell
Keywords: MESA, chemotherapy,NK/T cell lymphoma
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2013-09-02
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: response criteria for CR(complete remission)by physical examination,lymph nodes masses and bone marrow test.
timeFrame: 24 week
Secondary outcomes:
measure: rate of survival
timeFrame: 1 year, 2 years, 3years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of Hemaology, Xi jing Hospital,The Fourth Military Medical University
state: Shaanxi
Study officials:
References: