Study With Rituximab, Cyclophosphamide, Doxorubicin Liposomal (Myocet®), Vincristine, Prednisone, (R-COMP) to Treat Non-Hodgkin's Lymphoma

• Status: Unknown status
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter study phase II, open-label for cardiopathic patients affected by Non-Hodgkin's lymphoma diffuse large B cell CD20 + grade IIIb follicular. The purpose is to study the feasibility of R-COMP in this cohort of patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione Italiana Linfomi ONLUS
• Treatments: Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Prednisone; Rituximab; Vincristine

Criteria

Inclusion Criteria:

• NHL histological diagnosis of diffuse large B cell CD20 + (de novo or shift from low-grade NHL if not pretreated), grade IIIb follicular NHL;

• Age >= 18 years;

• Presence of at least 1 factor that defines the cardiopathy;

• Life expectancy > 3 months;

• In the case of women of childbearing age absence of pregnancy at the beginning of the chemotherapy;

• Written informed consent.

Exclusion Criteria:

• Histology different from NHL diffuse large cell CD20 + or follicular IIIb

• Age < 18 years

• Inability to sign informed consent;

• HIV positivity;

• Patients HBsAg positive;

• AST/ALT > 2 times the standard;

• Bilirubin > 2 times the standard;

• Creatinine > 2.5 mg / dl;

• Location of CNS disease;

• Pregnancy ongoing;

• Damage to that organ or medical problems that could interfere with the therapy;

• Current uncontrolled infection;

• Senile dementia