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

Asociacion Doctor Peset Para el Estudio de la Hematología

Status and phase: Unknown; Phase 2

Conditions: No Hodgkin B Lymphoma

Treatments: Drug: RCOMP-14 + rituximab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00849355

ADOPEH-LINFMYO-2007

Details and patient eligibility

About

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

Full description

Phase II, multicenter, open , 1-arm study.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

unique

Experimental group

Description:

RCOMP-14 with Rituximab

Treatment:

Drug: RCOMP-14 + rituximab