NCT01933282

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 2, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

December 24, 2013

Status Verified

December 1, 2013

Enrollment Period

2 years

First QC Date

August 16, 2013

Last Update Submit

December 21, 2013

Conditions

Lymphoma, Extranodal NK-T-Cell

Keywords

MESA, chemotherapy,NK/T cell lymphoma

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • rate of survival

    1 year, 2 years, 3years

Study Arms (1)

MESA chemotherapy

EXPERIMENTAL

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

Drug: MESA chemotherapyDrug: MESA

Interventions

MESA chemotherapyDRUG

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 chemotherapy
MESADRUG

Methotrexate etoposide dexamethasone Polyehylene glycol-asparaginase

MESA chemotherapy

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasms

Central Study Contacts

RONG LIANG, professor

CONTACT

86 13384933870rongliang1017@gmail.com

Li Zhu, nurse

CONTACT

96 029 84775203xueyeke@fmmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dean of Department of Hematology, Xijing Hosptial

Study Record Dates

First Submitted

August 16, 2013

First Posted

September 2, 2013

Study Start

January 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

December 24, 2013

Record last verified: 2013-12

Locations

CN(1)