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MESA Treatment for NK/T Cell Lymphoma (MTN)

Primary Purpose

Lymphoma, Extranodal NK-T-Cell

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

MESA chemotherapy

MESA

About this trial

This is an interventional treatment trial for Lymphoma, Extranodal NK-T-Cell focused on measuring MESA, chemotherapy,NK/T cell lymphoma

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

Department of Hemaology, Xi jing Hospital,The Fourth Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MESA chemotherapy

Arm 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01933282

First Posted

August 16, 2013

Last Updated

December 21, 2013

Sponsor

Air Force Military Medical University, China

1. Study Identification

Unique Protocol Identification Number

NCT01933282

Brief Title

MESA Treatment for NK/T Cell Lymphoma

Acronym

MTN

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Unknown status

Study Start Date

January 2013 (undefined)

Primary Completion Date

January 2015 (Anticipated)

Study Completion Date

January 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Air Force Military Medical University, China

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma, Extranodal NK-T-Cell

Keywords

MESA, chemotherapy,NK/T cell lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MESA chemotherapy

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

MESA chemotherapy

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

MESA

Intervention Description

Methotrexate etoposide dexamethasone Polyehylene glycol-asparaginase

Primary Outcome Measure Information:

Title

response criteria for CR(complete remission)by physical examination,lymph nodes masses and bone marrow test.

Description

Time Frame

24 week

Secondary Outcome Measure Information:

Title

rate of survival

Description

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.

Time Frame

1 year, 2 years, 3years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

RONG LIANG, professor

Phone

86 13384933870

rongliang1017@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Li Zhu, nurse

Phone

96 029 84775203

xueyeke@fmmu.edu.cn

Facility Information:

Facility Name

Department of Hemaology, Xi jing Hospital,The Fourth Military Medical University

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

rong liang, associate professor

Phone

86 13384933870

rongliang1017@gmail.com

First Name & Middle Initial & Last Name & Degree

Li Zhu, nurse

Phone

86 29 775202

xueyeke@fmmu.edu.cn

First Name & Middle Initial & Last Name & Degree

xie qun chen, professor

First Name & Middle Initial & Last Name & Degree

Rong Liang, associate professor

12. IPD Sharing Statement

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MESA Treatment for NK/T Cell Lymphoma

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