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Phase II study of MESA chemotherapy in patients with extranodal natural killer/T lymphoma

Phase II study of MESA chemotherapy in patients with extranodal natural killer/T lymphoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-PRNC-13003289
Enrollment
Unknown
Registered
2013-03-12
Start date
2012-08-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

extranodal NK/T cell lymphoma

Interventions

one cohort:methotrexate, etoposide, dexamethasone, Polyehylene glycol asparaginase

Sponsors

Department of Hematology, First Affiliated Hospitals (Xijing Hospital),Fourth Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Pathological diagnosis is NK/T cell lymphoma; 2. At least one objective evaluation ( measurable) lesions; 3. Aged 15 ~ 60 years old, men and women are not limited; 4. ECOG 0~3Expected to survive more than 3 months; 5. Heart, kidney function in the normal range; 6. Liver function: ALT < 2 times the normal value; 7. pregnancy tests of women childbearing age must be negative; Men and women agree to use effective contraception during the treatment and the following year; 8. Before the test sign the written informed consent.

Exclusion criteria

Exclusion criteria: 1. The early use of MTX or / and L-asparaginase; 2. Pregnant or nursing, psychiatric patients complicated with malignant tumor; 3. At the same time the application of other trial drug, drug contraindications exist in research; 4. Serious infection or metabolic diseases; 5. Liver dysfunction, serum direct bilirubin, indirect bilirubin, transaminas 2 times higher than normal; serum total protein or albumin below normal; 6. Renal insufficiency, creatinine clearance rate was 2 times higher than normal, especially the creatinine clearance rate is less than 30ml/min; 7. Before entering the group, blood: WBC < 3× 109/L; absolute neutrophil count < 1.5 ×109/L; platelet < 100*10^9/L (bone marrow is not violated); platelet count <75*10^9/L (bone marrow invasion); Hb < 100g/L; 8. 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; 9. HIV antibody positive, HBsAg positive after antiviral HBV DNA titer in 104copies/ml the following groups. HIV antibody positive, HBsAg+ and DNA titer in 104copies/ml after antiviral HBV therapy; 10. Coagulation abnormalities.

Design outcomes

Primary

MeasureTime frame
overall reactive rate;complete remission;

Countries

China

Contacts

Public ContactChen Xie-Qun, Liang Rong
xueyeke@fmmu.edu.cn+86 029-84775199, 84775209

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026