No Hodgkin B Lymphoma Clinical Trial
Official title:
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
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
| Status | Recruiting |
| Enrollment | 44 |
| Est. completion date | November 2010 |
| Est. primary completion date | November 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Spain | hospital del Mar | Barcelona | |
| Spain | Hospital Vall D'Hebrón | Barcelona | |
| Spain | Hospital de Castellon | Castellon | |
| Spain | Hospital de Getafe | Madrid | |
| Spain | Hospital Severo Ochoa | Madrid | |
| Spain | Hospital Universitario Puerta de Hierro | Madrid | |
| Spain | Hospital son Llatzer | Mallorca | |
| Spain | Hospital Morales Messeguer | Murcia | |
| Spain | Hospital Santa Mª del Rosell | Murcia | |
| Spain | H. Arnau de Vilanova | Valencia | |
| Spain | Hospital general universitario de Valencia | Valencia | |
| Spain | Hospital Universitario Dr. Peset | Valencia |
| Lead Sponsor | Collaborator |
|---|---|
| Asociacion Doctor Peset Para el Estudio de la Hematología | Cephalon, Pivotal S.L. |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluate treatment efficacy by measuring response to treatment | at the end of study | No | |
| Secondary | evaluate cardiotoxicity and tolerability | At the end of study | Yes | |
| Secondary | Evaluate progression free survival | At the end of study | No | |
| Secondary | Evaluate event free survival | At the end of study | No | |
| Secondary | Evaluate tumor free survival | At the end of study | No | |
| Secondary | Evaluate overall survival | At the end of study | No | |
| Secondary | Evaluate response duration | At the end of study | No | |
| Secondary | treatment adherence | At the end of study | No | |
| Secondary | time to progression | At the end of the study | No | |
| Secondary | dose intensity and relative dose intensity | At the end of the study | No |