drugset / Trial / NCT03479918
R-BL-M-04 Versus R-(DA)-EPOCH and Autologous Stem Cells Transplantation in Patients With High-Grade B-cell Lymphoma Double-hit (HGBL DH) and High-Grade B-cell Lymphoma Not Otherwise Specified (HGBL NOS)
RandomizedParallel-groupOpen-labelTreatment
Summary
Purpose: to evaluate an efficacy of chemotherapy regimens R-DA-EPOCH-21 and R-BL-04 with and without autologous hematopoietic stem cells transplantation (auto-SCT) in newly diagnosed patients with High-Grade B-cell Lymphoma Double-hit and High-Grade B-cell Lymphoma Not Otherwise Specified.
Timeline
- Start
- 2018-03-15
- Primary completion
- 2021-03-15
- Completion
- 2024-03-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cytarabine | Small molecule | 30 mg | Intravenous |
| Comparator | Cytarabine | Small molecule | 150 mg/m2 | Intravenous |
| Comparator | Cytarabine | Small molecule | 2000 mg/m2 | Intravenous |
| Comparator | Dexamethasone | Small molecule | 4 mg | Intravenous |
| Comparator | Dexamethasone | Small molecule | 10 mg/m2 | Intravenous |
| Comparator | Doxorubicin | Other / unclassified | 50 mg/m2 | Intravenous |
| Comparator | Etoposide | Small molecule | 100 mg/m2 | Intravenous |
| Comparator | Etoposide | Small molecule | 150 mg/m2 | Intravenous |
| Comparator | Ifosfamide | Small molecule | 800 mg/m2 | Intravenous |
| Comparator | Methotrexate | Small molecule | 15 mg | Intravenous |
| Comparator | Methotrexate | Small molecule | 1500 mg/m2 | Intravenous |
| Comparator | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Comparator | Vinblastine | Small molecule | 5 mg/m2 | Intravenous |
| Comparator | Vincristine | Small molecule | 2 mg | Intravenous |