drugset / Trial / NCT01719835
CHOP vs GEM-P in 1st Line Treatment of T-cell Lymphoma, Multicentre Phase II Study
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |