DA-EDOCH14-R in Poor-prognosis Diffuse Large B-cell Lymphoma
Summary
Poor prognosis dufuse large B-cell lymphoma (DLBCL) represents 50% of all DLBCL with overall cure rates ranging from 50-60% with modern dose-dense immunochemotherapy regimens such as R-CHOP14. Using an alternative strategy, as infusional and dose-adjusted R-EPOCH, the investigators have shown an 83% of complete responses (CR), with an estimated 5-year overall survival (OS) rate of 75% (García-Suárez et al. British Journal of Haematology 2007, 136:276). Despite this improvement in outcome, the search for new treatment strategies should continue. Therefore, compared with prior R-EPOCH the investigators decided to investigate whether the introduction of dexamethasone (40 mg IV on days 1-5) in place of prednisone (based upon data which demonstrated that the former was associated with enhanced Central Nervious System penetration) and the reduction of treatment intervals from 3 to 2 weeks would be feasible and might improve the outcome in this group of patients.
Timeline
- Start
- 2009-12
- Primary completion
- 2010-12
- Completion
- 2012-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclophosphamide | Other / unclassified | 750 mg/m2 | Intravenous |
| Comparator | Dexamethasone | Small molecule | 40 mg | Intravenous |
| Comparator | Doxorubicin | Other / unclassified | 10 mg/m2 | — |
| Comparator | Etoposide | Small molecule | 50 mg/m2 | — |
| Comparator | Prednisone | Other / unclassified | — | — |
| Comparator | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Comparator | Vincristine | Small molecule | 0.4 mg/m2 | — |
| Comparator | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | — | — |