MESA Treatment for NK/T Cell Lymphoma (MTN)

Air Force Military Medical University of People's Liberation Army

Status and phase: Unknown; Phase 2

Conditions: Lymphoma, Extranodal NK-T-Cell

Treatments: Drug: MESA; Drug: MESA chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01933282

MESA-NKT2013

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 15 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

MESA chemotherapy

Experimental group

Description:

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

Treatment:

Drug: MESA chemotherapy

Drug: MESA