drugset / Trial / NCT01719835

CHOP vs GEM-P in 1st Line Treatment of T-cell Lymphoma, Multicentre Phase II Study

NCT01719835

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomised, open-label phase II study comparing GEM-P chemotherapy (experimental arm) with CHOP (control arm) in previously untreated T-cell lymphoma. Eligible patients will be randomised 1:1 between 4-weekly GEM-P or 3-weekly CHOP chemotherapy.

Timeline

Start
2012-03
Primary completion
2016-11-30
Completion
2022-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 100 mg/m2 Intravenous
Comparator Cyclophosphamide Other / unclassified 750 mg/m2 Intravenous
Comparator Doxorubicin Other / unclassified 50 mg/m2 Intravenous
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous
Subject Methylprednisolone Other / unclassified 1000 mg Oral
Comparator Prednisolone Other / unclassified 100 mg Oral
Comparator Vincristine Small molecule 1.4 mg/m2 Intravenous