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

2014-07-24 14:10:01 | BioPortfolio

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.

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

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

Conditions

Diffuse Large B-Cell Lymphoma (DLBCL)

Intervention

Dexamethasone and dose-dense immunochemoterapy

Location

Principe de Asturias University Hospital
Alcala de Henares
Madrid
Spain
28805

Status

Recruiting

Source

Hospital Universitario Principe de Asturias

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:10:01-0400

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