drugset / Trial / NCT02842931
R-Dose-adjusted (DA) - EPOCH-21 Versus R-modified Non-Hodgkin Lymphoma (NHL)-Berlin-Frankfurt-Munster (BFM)-90 Program (mNHL-BFM-90) and Autologous Stem Cells Transplantation (Auto-SCT) in DLBCL With Poor Prognosis
Phase 3
Unknown
300 enrolled
National Research Center for Hematology, Russia
National Research Center for Hematology · collab
RandomizedFactorialOpen-labelTreatment
Summary
Purpose: to evaluate an efficacy of chemotherapy regimens R-DA-EPOCH-21 and R-mNHL-BFM-90 with and without autologous hematopoietic stem cells transplantation (auto-SCT) in newly diagnosed patients with DLBCL with intermediate and high risk.
Timeline
- Start
- 2015-02
- Primary completion
- 2020-02
- Completion
- 2023-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclophosphamide | Other / unclassified | 200 mg/m2 | Intravenous |
| Comparator | Cytarabine | Small molecule | 100 mg/m2 | Intravenous |
| Comparator | Dexamethasone | Small molecule | 10 mg/m2 | Intravenous |
| Comparator | Doxorubicin | Other / unclassified | 25 mg/m2 | Intravenous |
| Comparator | Etoposide | Small molecule | 100 mg/m2 | Intravenous |
| Comparator | Ifosfamide | Small molecule | 800 mg/m2 | Intravenous |
| Comparator | Methotrexate | Small molecule | 1000 mg/m2 | Intravenous |
| Comparator | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Comparator | Vincristine | Small molecule | 2 mg | Intravenous |