drugset / Trial / NCT00556127
Rituximab in Addition to Chemotherapy With Autologous Stem Cell Transplantation as Treatment Diffuse Large B-Cell Lymphoma
Phase 2
Completed
94 enrolled
Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this trial was to evaluate efficacy and safety of adding Rituximab to dose-dense and High-Dose Chemotherapy (HDC) with Autologous Stem Cell Transplantation (ASCT) as first line treatment in young patients with DLBCL at Intermediate-High and High risk aaIPI score
Timeline
- Start
- 2002-06
- Primary completion
- —
- Completion
- 2006-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | — |
| Background | Cyclophosphamide | Other / unclassified | 1200 mg/m2 | — |
| Background | Cytarabine | Small molecule | 2 g | — |
| Background | Dexamethasone | Small molecule | 4 mg/m2 | — |
| Background | Epirubicin | Small molecule | 110 mg/m2 | — |
| Background | Etoposide | Small molecule | 100 mg/m2 | — |
| Background | Granulocyte colony-stimulating factor | Protein / enzyme biologic | 5 ug/kg | — |
| Background | Melphalan | Small molecule | 140 mg/m2 | — |
| Background | Mitoxantrone | Small molecule | 8 mg/m2 | — |
| Background | Prednisone | Other / unclassified | 40 mg/m2 | — |
| Background | Vincristine | Small molecule | 1.4 mg/m2 | — |
| Background | carmustine | Small molecule | 300 mg/m2 | — |