The purpose of this study is to evaluate the efficacy and safety of High dose of Methotrexate combined with gemcitabine, pegaspargase and dexamethasone (GAD-M regimen) as first-line treatment in patients with de novo extranodal NK/T cell lymphoma.
Studies have shown that effects of P glycoprotein mediated chemotherapy resistance reduce the therapeutic efficacy of anthracycline-based chemotherapy of NK/T cell lymphoma, and agents like pegaspargase and large doses of Methotrexate is not affected by the P glycoprotein. A number of reports suggest that gemcitabine combined with other chemotherapy drugs has good application prospect in the treatment of lymphomas. Dexamethasone is used in combination with other agents for the treatment of lymphomas which may be implicated in the development or growth of some cancers. So we explored to evaluate the efficacy and safety of High dose of methotrexate combined with gemcitabine, pegaspargase and dexamethasone (GAD-M regimen) as first-line treatment in patients with untreated extranodal NK/T cell lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Methotrexate 3.0g/Kg, intravenous drip D1
Gemcitabine 1g/m2 intravenous drip D1,D8
Pegaspargase 2500U/m2 intramuscular injection (IM) D1
Department of Medical Oncology, Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Overall Response Rate (ORR)
21 days (3 weeks) for one cycle, Efficacy was evaluated every two cycles
Time frame: every 6 weeks, up to completion of treatment (approximately 6 months)
Progress Free Survival (PFS)
Time frame: up to end of follow-up-phase (approximately 5 years)
Overall Survival (OS)
Time frame: up to the date of death (approximately 5 years)
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Dexamethasone 20mg/d intravenous drip D1, po D2-3