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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00849355

Enrollment

Registered

2009-02-23

Start date

2008-08-31

Completion date

2010-11-30

Last updated

2009-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

No Hodgkin B Lymphoma

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.

Interventions

DRUGRCOMP-14 + rituximab

Pretreatment: vincristine 1mg at day -6 and Methylprednisolone 100 mg from -6 to day 0. Treatment: rituximab 375m/m2 + ciclophosphamide 750 mg/m2 + Vincristine 1.4 mg/m2 + Doxorrubicine 50 mg/m2 at day 1 and every 14d. Prednisone 100 mg/d from day 1 to 5 and every 14 d.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Evaluate treatment efficacy by measuring response to treatment	at the end of study

Secondary

Measure	Time frame
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 cardiotoxicity and tolerability	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
Evaluate response duration	At the end of study

Countries

Spain

Contacts

Primary ContactSecundino Ferrer

ferrer_sec@gva.es+34961622536

Backup ContactFelix Carbonell

carbonell_fel@gav.es+34961972000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026