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

Fondazione Italiana Linfomi - ETS

Status and phase: Unknown; Phase 2

Conditions: Diffuse Large B-Cell Lymphoma

Treatments: Drug: Doxorubicin; Drug: Prednisone; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Vincristine

Study type: Interventional

Funder types: Other

Identifiers

NCT01009970

IIL-HEART01

2009-012143-42

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

1

Experimental group

Description:

R-COMP

Treatment:

Drug: Vincristine

Drug: Prednisone

Drug: Doxorubicin

Drug: Cyclophosphamide

Drug: Rituximab