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

Study Overview
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Brief Summary
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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
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Phase II, multicenter, open , 1-arm study.

Official Title
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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

Conditions
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No Hodgkin B Lymphoma

Intervention / Treatment
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* Drug: RCOMP-14 + rituximab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: unique<br>RCOMP-14 with Rituximab | Drug: RCOMP-14 + rituximab<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate treatment efficacy by measuring response to treatment |  | at the end of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate cardiotoxicity and tolerability |  | At the end of study | 
| Evaluate progression free survival |  | At the end of study | 
| Evaluate event free survival |  | At the end of study | 
| Evaluate tumor free survival |  | At the end of study | 
| Evaluate overall survival |  | At the end of study | 
| Evaluate response duration |  | At the end of study | 
| treatment adherence |  | At the end of study | 
| time to progression |  | At the end of the study | 
| dose intensity and relative dose intensity |  | At the end of the study |