Pegaspargase and Methotrexate Based Regimens for Newly Diagnosed Extranodal NK/T Cell Lymphoma

• Status: Completed
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Extranodal NK/T cell lymphoma is an aggressive tumor with higher incidence in Asia.Traditional CHOP/CHOP-like regiment can't produce satisfied outcome for the patients. Asparaginase-based treatment has been demonstrated as promising response rate and survival superiority. Stage-specified regimen may bring out exciting efficacy with good safety.

• Phase: Phase 2
• 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