Treatment With Infusional Dose-adjusted Etoposide/Vincristine/Doxorubicin/Bolus Cyclophosphamide/Dexamethasone and Rituximab (DA-EDOCH14-R) in Patients With Poor-prognosis Diffuse Large B-cell Lymphoma
Medication, Dose and Method for Administration:
- Rituximab: 375 mg/m2, endovenous, according to the protocol of the service, day 1
(except in the first cycle, in which it will be on day 5).
- Etoposide: 50 mg/m2/day, in continuous 24-hour infusion, days 1 to 4.
- Adriamycin: 10 mg/m2/day, in continuous 24-hour infusion of, days 1 to 4.
- Vincristine: 0.4 mg/m2/day, in continuous 24-hour infusion, days 1 to 4
- Dexamethasone: 40 mg, endovenous, days 1 to 5. Followed by prednisone 30 mg (day +6),
20 mg (day +7), and 10 mg (day +8).
- Cyclophosphamide: 750 mg/m2, endovenous, in 30 minutes, day 5, after ending the
continuous infusion of adriamycin, etoposide and vincristine.
- MESNA (If the dose of Cyclophosphamide is > 1 g/m2
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
efficacy of the EDOCH14-R scheme at an adjusted dose
Between December 2009 and January 2012
Yes
Julio Garcia-Suarez, MD, PhD
Principal Investigator
Service of Hematology, Principe de Asturias University Hospital,
Spain: Ethics Committee
DA-EDOCH14-R/07
NCT01066429
December 2009
December 2012
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