drugset / Trial / NCT01361191
Early Treatment Stratification Based on PET Scan Response to Chemotherapy in Patients With Diffuse Large B-cell Lymphoma
NaSingle-groupOpen-labelTreatment
Summary
The aim of the study is to evaluate the event free survival at three years in patients with diffuse large B-cell lymphoma with poor prognostic factors receiving R-MegaCHOP as induction therapy. Patients with positive PET after three cycles of R-MegaCHOP receive early salvage treatment with R-IFE and autologous stem cell transplantation. Patients with negative PET after three cycles of R-MegaCHOP are treated with three additional cycles of R-MegaCHOP without transplant.
Timeline
- Start
- 2007-06
- Primary completion
- 2012-09
- Completion
- 2012-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CYCLOPHOSPHAMIDE ANHYDROUS | Small molecule | 1500 mg/m2 | Intravenous |
| Subject | Doxorubicin | Other / unclassified | 65 mg/m2 | Intravenous |
| Subject | Etoposide | Small molecule | 900 mg/m2 | Intravenous |
| Subject | Ifosfamide | Small molecule | 10 g | Intravenous |
| Subject | Prednisone | Other / unclassified | 60 mg/m2 | Intravenous |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Subject | Vincristine | Small molecule | 1.4 mg/m2 | Intravenous |