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

Phase 2

• Conditions: Diffuse Large B-Cell Lymphoma
• Interventions: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Prednisone; Drug: Doxorubicin

• Registration Number: NCT01009970
• Lead Sponsor: Fondazione Italiana Linfomi - ETS

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-11-06
• Study First Submitted QC: 2009-11-06
• Study First Posted: 2009-11-09
• Study Start: 2010-05
• Primary Completion: 2011-05
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-12
• Last Update Posted: 2011-10-13
• Study Completion: 2012-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Vincristine	R-COMP
1	Rituximab	R-COMP
1	Cyclophosphamide	R-COMP
1	Prednisone	R-COMP
1	Doxorubicin	R-COMP

Primary Outcome Measures

Name	Time	Method
Feasibility of R-COMP in cardiopathic patients	2 years

Secondary Outcome Measures

Name	Time	Method
Response rates	1 year
Progression free survival	2 years
Overall Survival	3 years

Trial Locations

Locations (32)

Ospedale Sant'Eugenio; 🇮🇹 Roma, Italy

Ospedale Riuniti; 🇮🇹 Trieste, Italy

Ospedale SS Antonio Biagio e Cesare Arrigo; 🇮🇹 Alessandria, Italy

Ospedale Civitanova Marche; 🇮🇹 Civitanova Marche, Italy

Università di Bari; 🇮🇹 Bari, Italy

Ospedale degli Infermi; 🇮🇹 Biella, Italy

Ospedale San Carlo; 🇮🇹 Cosenza, Italy

Ospedale Santa Maria della Misericordia; 🇮🇹 Perugia, Italy

Ospedale Vito Fazzi; 🇮🇹 Lecce, Italy

Istituto Scientifico Romagnolo per lo studio e la cura dei tumori (IRST); 🇮🇹 Meldola (FC), Italy

A O Papardo; 🇮🇹 Messina, Italy

Ospedale Niguarda Cà Granda; 🇮🇹 Milano, Italy

Istituto Regina Elena; 🇮🇹 Roma, Italy

Università La Sapienza; 🇮🇹 Roma, Italy

Clinica Humanitas; 🇮🇹 Rozzano (MI), Italy

Casa sollievo della sofferenza; 🇮🇹 San giovanni Rotondo, Italy

Università di Sassari; 🇮🇹 Sassari, Italy

Azienda Ospedaliera senese; 🇮🇹 Siena, Italy

Ospedale San Giovanni Battista Molinette; 🇮🇹 Torino, Italy

Santa Maria della Misericordia; 🇮🇹 Udine, Italy

Ospedale di circolo e Fondazione Macchi; 🇮🇹 Varese, Italy

Spedali Civili; 🇮🇹 Brescia, Italy

AO Annunziata; 🇮🇹 Cosenza, Italy

Ospedale San Raffaele; 🇮🇹 Milano, Italy

Centro oncologico modenese; 🇮🇹 Modena, Italy

AO Universitaria Paolo Giaccone; 🇮🇹 Palermo, Italy

A O Universitaria di Parma; 🇮🇹 Parma, Italy

Ausl Rimini; 🇮🇹 Rimini, Italy

Ospedale La Maddalena; 🇮🇹 Palermo, Italy

Ospedale Bianchi Melacrino Morelli; 🇮🇹 Reggio Calabria, Italy

Ausl Ravenna; 🇮🇹 Ravenna, Italy

AO Santa Maria Nuova; 🇮🇹 Reggio Emilia, Italy