Status:
UNKNOWN
Ciclophosphamide, Vincristine, Myocet and Prednisone, With Rituximab in 1st-Line Treatment for Patients With No-Hodgkin B Lymphoma and Cardiovascular (CV) Risk
Lead Sponsor:
Asociacion Doctor Peset Para el Estudio de la Hematología
Collaborating Sponsors:
Cephalon
Pivotal S.L.
Conditions:
No Hodgkin B Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 Rituxi...
Detailed Description
Phase II, multicenter, open , 1-arm study.
Eligibility Criteria
Inclusion
- 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
- Age \>18
- ECOG 0-2
- 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
- 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
- Known Hypersensivity to any atudy drug
- pregnant/lactant women
- Previous participation in clinicla study in past 30 days
- Previous treatment with antraciclines or any drug used in this study
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2010
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00849355
Start Date
August 1 2008
End Date
November 1 2010
Last Update
February 23 2009
Active Locations (12)
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1
hospital del Mar
Barcelona, Spain, 08003
2
Hospital Vall D'Hebrón
Barcelona, Spain, 08035
3
Hospital de Castellon
Castellon, Spain, 12004
4
Hospital Severo Ochoa
Madrid, Spain, 28211