drugset / Trial / NCT00791947
A Nordic Phase II Study of PTCL Based on Dose-intensive Induction and High-dose Consolidation With ASCT
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is a phase II prospective non-randomised clinical trial in newly diagnosed and previously untreated adult patients in the age range 18-60 (67) years with peripheral T-cell lymphoma. The treatment schedule will consist of three phases: induction and high-dose consolidation, followed by autologous stem cell rescue. There will be two different induction schedules: one for patients in the age range 18-60 years and one for patients aged over 60 years.
Timeline
- Start
- 2001-10
- Primary completion
- 2008-08
- Completion
- 2010-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 750 mg/m2 | Intravenous |
| Subject | Cytarabine | Small molecule | 200 mg/m2 | Intravenous |
| Subject | Cytarabine | Small molecule | 400 mg/m2 | Intravenous |
| Subject | Doxorubicin | Other / unclassified | 50 mg/m2 | Intravenous |
| Subject | Etoposide | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Melphalan | Small molecule | 140 mg/m2 | Intravenous |
| Subject | Prednisone | Other / unclassified | 100 mg | Oral |
| Subject | Vincristine | Small molecule | 1.4 mg/m2 | Intravenous |
| Subject | carmustine | Small molecule | 300 mg/m2 | Intravenous |