MESA Treatment for NK/T Cell Lymphoma

Lymphoma, Extranodal NK-T-Cell Clinical Trial

— MTN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01933282
• Other study ID #: MESA-NKT2013
• Status: Recruiting
• Phase: Phase 2
• First received: August 16, 2013
• Last updated: December 21, 2013
• Start date: January 2013
• Est. completion date: January 2015

Study information

• Verified date: December 2013
• Source: Fourth Military Medical University
• Contact: RONG LIANG, professor
• Phone: 86 13384933870
• Email: rongliang1017[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of HealthChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 60 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Extranodal NK-T-Cell
• Lymphoma, T-Cell

Intervention

Drug:
• MESA chemotherapy
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
• MESA
Methotrexate etoposide dexamethasone Polyehylene glycol-asparaginase

Locations

Country	Name	City	State
China	Department of Hemaology, Xi jing Hospital,The Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response 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	24 week	Yes
Secondary	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.	1 year, 2 years, 3years	Yes