Phase II, Multicenter Trial to Evaluate the Efficacy and Safety of the Following Treatment Squeme:Ciclophosphamide, Vincristine, Lyposomal Doxorrubicine, Myocet and Prednisone,Combined With Rituximab in First Line Treatment for Patients With Aggresive No Hodgkin B Lymphoma and Cardiovascular Risk

Asociacion Doctor Peset Para el Estudio de la Hematología12 sites in 1 country44 target enrollmentAugust 2008

ConditionsNo Hodgkin B Lymphoma

InterventionsRCOMP-14 + rituximab

DrugsRCOMP-14 + rituximab

Overview

Phase: Phase 2
Intervention: RCOMP-14 + rituximab
Conditions: No Hodgkin B Lymphoma
Sponsor: Asociacion Doctor Peset Para el Estudio de la Hematología
Enrollment: 44
Locations: 12
Primary Endpoint: Evaluate treatment efficacy by measuring response to treatment
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the efficacy (and safety) of the following treatment squeme:Ciclophosphamide, Vincristine, lyposomal Doxorrubicine (Myocet) and Prednisone,combined with Rituximab in first line treatment for patients with aggresive No Hodgkin B lymphoma and cardiovascular risk

Detailed Description

Phase II, multicenter, open , 1-arm study.

Registry

clinicaltrials.gov

Start Date

August 2008

End Date

November 2010

Last Updated

17 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Asociacion Doctor Peset Para el Estudio de la Hematología

Eligibility Criteria

Inclusion Criteria

•Patients with histological diagnosis of Lymphoma no Hodgkin B CD20+ high degree of mailgnancy
•Patients no previously treated
•stage III o IV
•Informed consent
•At least one measurable injury
•Life expectancy \>6 months
•Cardiovascular risk defined as:Mild-moderate systolic dysfunction,isquemic cardiopathy, diabetes mellitus, hypertension,left ventricular hypertrophy, cardiac arrhythmia, moderate pulmonar hypertension
•adequate organic functionallity (creatinine\<2mg/dl;bilirubin\<2mg/dl; ALT-AST-FA\<5 FSN; neutrphyls total count \>1.5x 109/l and platellet count \>100x1097l)
•Use of a contraceptive method during study + 3 months -

Exclusion Criteria

•stage I or II with IPI=0
•Symptomatic tumoral affection of Nervous central system
•Lymphoma no hodgkin B indolent
•Lymphoma no hodgkin B mantle-cell
•Lymphoma no hodgkin T
•lymphoprolifertaive syndrome post-transplantation or immunosuppression associated
•cardiovacualr disease symptomatic
•Cronic infection or acute serious
•history of neoplasia in past 5 years
•not able to understand the study or poor protocol adherence