MESA Versus ESA in the Treatment of Early Stage NK/T-cell Lymphoma

• Status: Active, not recruiting
• Trial end date: 2022-07-17
• Target enrollment: 0
• Participant gender: All

Summary

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, with poor prognosis. Radiotherapy plus chemotherapy has improved the survival for these patients. But the optimal treatment schedule is controversial. The previous protocols usually contained high dose methotrexate, but the application of them is limited for the toxicity.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ruijin Hospital
• Treatments: Asparaginase; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Etoposide; Etoposide phosphate; Methotrexate; Pegaspargase

Criteria

Inclusion Criteria:

• Pathological diagnosis of extranodal NK/T cell lymphoma, nasal type, previously untreated

• Age 14 ~ 70 years old

• ECOG(Eastern Cooperative Oncology Group）performance status 0~2

• Stage I to II

• Life expectancy>6 months

• Informed consented

Exclusion Criteria:

• Chemotherapy before

• Bone marrow transplantation before

• History of malignancy

• Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease

• LVEF≤50%

• Other uncontrollable medical condition that may that may interfere the participation of the study

• Lab at enrollment ALT or AST >3*ULN, AKP or bilirubin >2.5*ULN Creatinine>1.5*ULN

• Not able to comply to the protocol for mental or other unknown reasons

• Pregnant or lactation

• HIV infection