Trial | NCT00849355  Report issue

Title

Ciclophosphamide, Vincristine, Myocet and Prednisone, With Rituximab in 1st-Line Treatment for Patients With No-Hodgkin B Lymphoma and Cardiovascular (CV) Risk
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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    44
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
Phase II, multicenter, open , 1-arm study.
Study Started
Aug 31
2008
Primary Completion
Nov 30
2009
Anticipated
Study Completion
Nov 30
2010
Anticipated
Last Update
Feb 23
2009
Estimate

Drug RCOMP-14 + rituximab

Pretreatment: vincristine 1mg at day -6 and Methylprednisolone 100 mg from -6 to day 0. Treatment: rituximab 375m/m2 + ciclophosphamide 750 mg/m2 + Vincristine 1.4 mg/m2 + Doxorrubicine 50 mg/m2 at day 1 and every 14d. Prednisone 100 mg/d from day 1 to 5 and every 14 d.

unique Experimental

RCOMP-14 with Rituximab

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
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 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
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
No Results Posted