drugset / Trial / NCT01501149

Summary

The purpose of this study is to evaluate the efficacy and safety of DDGP regiment (gemcitabine,pegaspargase,cisplatin,dexamethasone) for patients with stage Ⅲ/Ⅳ Natural Killer (NK)/T Cell Lymphoma.

Timeline

Start
2011-01
Primary completion
2015-12
Completion
2019-05

Outcome

Met primary endpoint

paper At a median follow-up of 41.5 months, the median PFS was not reached in the DDGP group vs 6.8 months in the SMILE group (HR, 0.42; 95% CI, 0.23-0.77; P = .004) PMID 35708709 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject 2-MERCAPTOETHANESULFONIC ACID Small molecule 240 mg/m2 Intravenous
Subject Cisplatin Other / unclassified 20 mg/m2 Intravenous
Subject Dexamethasone Small molecule 15 mg/m2 Intravenous
Subject Dexamethasone Small molecule 40 mg Intravenous
Subject Etoposide Small molecule 100 mg/m2 Intravenous
Subject Gemcitabine Small molecule 800 mg/m2 Intravenous
Subject Ifosfamide Small molecule 1.5 g Intravenous
Subject L-asparaginase Protein / enzyme biologic 6000 unknown Intravenous
Subject Methotrexate Small molecule 2 g Intravenous
Subject Pegaspargase Protein / enzyme biologic 2500 iu Intramuscular