drugset / Trial / NCT02359162

Efficacy and Safety Study of P-Gemox vs.EPOCH as First-line Chemotherapy to Treat NK/T-cell Lymphoma With Early Stage

NCT02359162

Phase 3 Terminated 50 enrolled Sun Yat-sen University
RandomizedParallel-groupOpen-labelTreatment

Summary

Purpose :To compare the efficacy and and safety of the P-Gemox chemotherapy regimen with those of the EPOCH regimen for stage IE to IIE ENKTL.

Timeline

Start
2015-05
Primary completion
2017-06
Completion
2017-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cyclophosphamide Other / unclassified 750 mg/m2 Intravenous
Comparator Doxorubicin Other / unclassified 10 mg/m2
Comparator Etoposide Small molecule 50 mg/m2
Subject Gemcitabine Small molecule 1250 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous
Subject Pegaspargase Protein / enzyme biologic 2500 iu Intramuscular
Comparator Prednisone Other / unclassified 60 mg/m2
Comparator Vincristine Small molecule 0.4 mg/m2