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

Phase 2

• Conditions: No Hodgkin B Lymphoma
• Interventions: Drug: RCOMP-14 + rituximab

• Registration Number: NCT00849355
• Lead Sponsor: Asociacion Doctor Peset Para el Estudio de la Hematología

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.

Study Timeline

• Study Start: 2008-08
• Status Verified: 2009-02
• Study First Submitted: 2009-02-20
• Study First Submitted QC: 2009-02-20
• Last Update Submitted: 2009-02-20
• Study First Posted: 2009-02-23
• Last Update Posted: 2009-02-23
• Primary Completion: 2009-11
• Study Completion: 2010-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

1. Patients with histological diagnosis of Lymphoma no Hodgkin B CD20+ high degree of mailgnancy
2. Patients no previously treated
3. stage III o IV
4. Informed consent
5. At least one measurable injury
6. Age >18
7. ECOG 0-2
8. Life expectancy >6 months
9. Cardiovascular risk defined as:Mild-moderate systolic dysfunction,isquemic cardiopathy, diabetes mellitus, hypertension,left ventricular hypertrophy, cardiac arrhythmia, moderate pulmonar hypertension
10. 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)
11. Use of a contraceptive method during study + 3 months -

Exclusion Criteria

1. stage I or II with IPI=0
2. Symptomatic tumoral affection of Nervous central system
3. Lymphoma no hodgkin B indolent
4. Lymphoma no hodgkin B mantle-cell
5. Lymphoma no hodgkin T
6. lymphoprolifertaive syndrome post-transplantation or immunosuppression associated
7. cardiovacualr disease symptomatic
8. Cronic infection or acute serious
9. history of neoplasia in past 5 years
10. not able to understand the study or poor protocol adherence
11. Known Hypersensivity to any atudy drug
12. pregnant/lactant women
13. Previous participation in clinicla study in past 30 days
14. Previous treatment with antraciclines or any drug used in this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
unique	RCOMP-14 + rituximab	RCOMP-14 with Rituximab

Primary Outcome Measures

Name	Time	Method
Evaluate treatment efficacy by measuring response to treatment	at the end of study

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (12)

Hospital son Llatzer; 🇪🇸 Mallorca, Spain

hospital del Mar; 🇪🇸 Barcelona, Spain

Hospital Universitario Puerta de Hierro; 🇪🇸 Madrid, Spain

Hospital de Castellon; 🇪🇸 Castellon, Spain

Hospital Severo Ochoa; 🇪🇸 Madrid, Spain

Hospital Vall D'Hebrón; 🇪🇸 Barcelona, Spain

Hospital de Getafe; 🇪🇸 Madrid, Spain

Hospital general universitario de Valencia; 🇪🇸 Valencia, Spain

Hospital Santa Mª del Rosell; 🇪🇸 Murcia, Spain

Hospital Morales Messeguer; 🇪🇸 Murcia, Spain

H. Arnau de Vilanova; 🇪🇸 Valencia, Spain

Hospital Universitario Dr. Peset; 🇪🇸 Valencia, Spain