Overview

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

Status:
Unknown status

Trial end date:
2010-11-01

Target enrollment:
0

Participant gender:
All

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

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Asociacion Doctor Peset Para el Estudio de la Hematología

Collaborators:

Cephalon
Pivotal S.L.

Treatments:

Prednisone
Rituximab
Vincristine

Criteria

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