drugset / Trial / NCT01827605
A Phase III Multicenter, Randomized Study Comparing RIT Vs ASCT in Patients With Relapsed/Refractory (FL)
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase III, multicenter, open-label, randomized and controlled study to compare the efficacy of a consolidation therapy with RIT versus ASCT in patients with FL in CR or PR after second or third line chemotherapy supplemented with rituximab.
Timeline
- Start
- 2012-01
- Primary completion
- 2019-10
- Completion
- 2024-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cytarabine | Small molecule | 200 mg/m2 | Intravenous |
| Subject | Etoposide | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Melphalan | Small molecule | 140 mg/m2 | Intravenous |
| Subject | carmustine | Small molecule | 300 mg/m2 | Intravenous |
| Background | Lenograstim | Protein / enzyme biologic | 5 ug/kg | Subcutaneous |
| Background | filgrastim | Protein / enzyme biologic | 5 ug/kg | Subcutaneous |