Clinical trial NCT00849355: Ciclophosphamide, Vincristine, Myocet and Prednisone, With Rituximab in 1st-Line Treatment for Patients With No-Hodgkin B Lymphoma and Cardiovascular (CV) Risk
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: No Hodgkin B Lymphoma
Lead sponsor: Asociacion Doctor Peset Para el Estudio de la Hematología
Sponsor class: OTHER
Collaborators: name: Cephalon
name: Pivotal S.L.
First posted: 2009-02-23
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Evaluate treatment efficacy by measuring response to treatment
timeFrame: at the end of study
Secondary outcomes:
measure: evaluate cardiotoxicity and tolerability
timeFrame: At the end of study
measure: Evaluate progression free survival
timeFrame: At the end of study
measure: Evaluate event free survival
timeFrame: At the end of study
measure: Evaluate tumor free survival
timeFrame: At the end of study
measure: Evaluate overall survival
timeFrame: At the end of study
measure: Evaluate response duration
timeFrame: At the end of study
measure: treatment adherence
timeFrame: At the end of study
measure: time to progression
timeFrame: At the end of the study
measure: dose intensity and relative dose intensity
timeFrame: At the end of the study
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Vall D'Hebrón
city: Castellon
country: Spain
facility: Hospital de Castellon
city: Madrid
country: Spain
facility: Hospital Severo Ochoa
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Madrid
country: Spain
facility: Hospital de Getafe
city: Mallorca
country: Spain
facility: Hospital son Llatzer
city: Murcia
country: Spain
facility: Hospital Morales Messeguer
city: Murcia
country: Spain
facility: Hospital Santa Mª del Rosell
city: Valencia
country: Spain
facility: Hospital general universitario de Valencia
city: Valencia
country: Spain
facility: H. Arnau de Vilanova
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset
Study officials:
References: