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

Diffuse Large B-Cell Lymphoma (DLBCL) Clinical Trial

Official title: 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 Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diffuse Large B-Cell Lymphoma (DLBCL)
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

• NCT number: NCT01066429
• Study type: Interventional
• Source: Hospital Universitario Principe de Asturias
• Contact: Julio Garcia-Suarez, MD, PhD
• Phone: 34-91-8878100
• Email: jgarciasu.hupa@salud.madrid.org
• Status: Recruiting
• Phase: Phase 2
• Start date: December 2009
• Completion date: December 2012