Clinical trial · Interventional
MESA Treatment for NK/T Cell Lymphoma
Phase II Study of MESA Chemotherapy in Patients With Natural Killer/T Cell Lymphoma
NCT01933282CI-TRIAL-00013223MTNunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Study on the efficacy and safety of MESA chemotherapy for treating NK/T cell lymphoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Extranodal NK-T-Cell | Nasal Type Extranodal NK/T-Cell Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MESA | Drug | — | UNRESOLVED |
| MESA chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MESA chemotherapy
- 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
- interventionNames
- Drug: MESA chemotherapy
- Drug: MESA
Primary outcomes (1)
- measure
- response criteria for CR(complete remission)by physical examination,lymph nodes masses and bone marrow test.
- timeFrame
- 24 week
- description
- 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 outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.