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MESA Treatment for NK/T Cell Lymphoma

NCT ID: NCT01933282

Last Updated: 2013-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Lymphoma, Extranodal NK-T-Cell

Keywords

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MESA, chemotherapy,NK/T cell lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MESA chemotherapy

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

Group Type EXPERIMENTAL

MESA chemotherapy

Intervention Type DRUG

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

Intervention Type DRUG

Methotrexate etoposide dexamethasone Polyehylene glycol-asparaginase

Interventions

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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

Intervention Type DRUG

MESA

Methotrexate etoposide dexamethasone Polyehylene glycol-asparaginase

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Air Force Military Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Xie-qun Chen

Dean of Department of Hematology, Xijing Hosptial

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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RONG LIANG, professor

Role: CONTACT

Phone: 86 13384933870

Email: [email protected]

Li Zhu, nurse

Role: CONTACT

Phone: 96 029 84775203

Email: [email protected]

Facility Contacts

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rong liang, associate professor

Role: primary

Li Zhu, nurse

Role: backup

Other Identifiers

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MESA-NKT2013

Identifier Type: -

Identifier Source: org_study_id