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

IIL INTERGRUPPO ITALIANO LINFOMI ONLUS0 sites50 target enrollmentAugust 11, 2009

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Diffuse Non-Hodgkin`s lymphoma, large B cells of the cardiopathic patient
Sponsor: IIL INTERGRUPPO ITALIANO LINFOMI ONLUS
Enrollment: 50
Status: Active, not recruiting
Last Updated: 9 years ago

No summary available.

Registry

who.int

Start Date

August 11, 2009

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

IIL INTERGRUPPO ITALIANO LINFOMI ONLUS

•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

•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