Official Title: “Multicenter Study of Phase II With Rituximab, Cyclophosphamide, Doxorubicin Liposomal (Myocet ®), Vincristine, Prednisone, (R-COMP) in Non-Hodgkin's Lymphoma Diffuse Large B Cell in Cardiopathic Patients”

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.

Study Type: Interventional

Study Design: Treatment, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: May 2011

Intervention(s) in this Clinical Trial

• Drug: Rituximab
  • 375 mg/m2 day 1
• Drug: Cyclophosphamide
  • 750 mg/m2 day 2
• Drug: Vincristine
  • 1,4 mg/m2 (max 2 mg) day 2
• Drug: Prednisone
  • 40 mg/m2 day 2-6
• Drug: Doxorubicin
  • 50 mg/m2 day 2

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • R-COMP

Primary Measures

• Feasibility of R-COMP in cardiopathic patients
  • Time Frame: 2 years
    Safety Issue?: Yes

Secondary Measures

• Response rates
  • Time Frame: 1 year
    Safety Issue?: Yes
• Progression free survival
  • Time Frame: 2 years
    Safety Issue?: Yes
• Overall Survival
  • Time Frame: 3 years
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Months

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Fondazione Intergruppo Italiano Linfomi Onlus

Overall Clinical Trial Officials and Contacts

Michele Spina, MD Study Director Centro di riferimento Oncologico di Aviano  

Overall Contact: Daniela Denaro 0039-0131-206129 ddenaro@ospedale.al.it

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01009970

Study ID Number: IIL-HEART01

ClinicalTrials.gov Identifier: NCT01009970

Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health