NCT01066429

DA-EDOCH14-R in Poor-prognosis Diffuse Large B-cell Lymphoma

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Hospital Universitario Principe de Asturias · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Diffuse Large B-Cell Lymphoma (DLBCL)

Interventions

Type	Name	Description
DRUG	Dexamethasone and dose-dense immunochemoterapy	Administration every 14 days of the EDOCH-R scheme.

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-12-01
• Completion: 2012-12-01
• First posted: 2010-02-10
• Last updated: 2010-02-12

Locations

1 site across 1 country: Spain