Multicenter study of phase II with Rituximab, cyclophosphamide, doxorubicin liposomal (Myocet), vincristine, Prednisone, (R-COMP) in diffuse Non-Hodgkin`s lymphoma, large B cells of the cardiopathic patient - HEART01

Phase 1

• Conditions: Diffuse Non-Hodgkin`s lymphoma, large B cells of the cardiopathic patient; MedDRA version: 9.1Level: PTClassification code 10012818

• Registration Number: EUCTR2009-012143-42-IT
• Lead Sponsor: IIL INTERGRUPPO ITALIANO LINFOMI ONLUS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-11
• Last Update Posted: 31 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. NHL histological diagnosis of diffuse large B cell CD20 + (de novo or shift from low-grade NHL if not pretreated), grade IIIb follicular NHL; 2.Age >= 18 years; 3.Presence of at least 1 factor that defines the cardiopathy(see Annex F); 4.Life expectancy > 3 months; 5.In the case of women of childbearing age absence of pregnancy at the beginning of the chemotherapy; 6.Written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Histology different from NHL diffuse large cell CD20 + or follicular IIIb 2.Age < 18 years 3.Inability to sign informed consent; 4.HIV positivity; 5.Patients HBsAg positive; 6.AST / ALT > 2 times the standard; 7.Bilirubin > 2 times the standard; 8.Creatinina > 2.5 mg / dl; 9.Location of CNS disease; 10.Pregnancy ongoing; 11.Damage to that organ or medical problems that could interfere with the therapy; 12.Current uncontrolled infection; 13.Senile dementia

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified