Ciclophosphamide, Vincristine, Myocet and Prednisone, With Rituximab in 1st-Line Treatment for Patients With No-Hodgkin B Lymphoma and Cardiovascular (CV) Risk
Conditions
No Hodgkin B Lymphoma
Conditions: official terms
Lymphoma
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: RCOMP-14 + rituximab
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
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
Locations
hospital del Mar
Barcelona, Spain
Status: Active, not recruiting
Hospital Vall D'Hebrón
Barcelona, Spain
Status: Active, not recruiting
Hospital de Castellon
Castellon, Spain
Status: Active, not recruiting
Hospital de Getafe
Madrid, Spain
Status: Recruiting
Contact: Jose García - +34916839360 - garciavela.joseantonio@gmail.com
Hospital Severo Ochoa
Madrid, Spain
Status: Not yet recruiting
Contact: Pedro Sanchez - +34914818000 - psanchez.hsvo@salud.madrid.org
Hospital Universitario Puerta de Hierro
Madrid, Spain
Status: Active, not recruiting
Hospital son Llatzer
Mallorca, Spain
Status: Active, not recruiting
Hospital Morales Messeguer
Murcia, Spain
Status: Not yet recruiting
Contact: Jose Sanchez - +34606388315 - josej.sanchezz3@carm.es
Hospital Santa Mª del Rosell
Murcia, Spain
Status: Not yet recruiting
Contact: Antonio Martinez - +34968504800 - amartifran@ono.com
H. Arnau de Vilanova
Valencia, Spain
Status: Active, not recruiting
Hospital general universitario de Valencia
Valencia, Spain
Status: Active, not recruiting
Hospital Universitario Dr. Peset
Valencia, Spain
Status: Active, not recruiting
Start Date
August 2008
Completion Date
November 2010
Sponsors
Asociacion Doctor Peset Para el Estudio de la Hematología
Source
Asociacion Doctor Peset Para el Estudio de la Hematología
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page