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

Diffuse Large B-Cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01009970
• Other study ID #: IIL-HEART01
• Secondary ID: 2009-012143-42
• Status: Unknown status
• Phase: Phase 2
• First received: November 6, 2009
• Last updated: October 12, 2011
• Start date: May 2010
• Est. completion date: May 2012

Study information

• Verified date: October 2011
• Source: Fondazione Italiana Linfomi ONLUS
• Contact: Daniela Denaro
• Phone: 0039-0131-206129
• Email: ddenaro[@]ospedale.al.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 50
• Est. completion date: May 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Diffuse Large B-Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Non-Hodgkin

Intervention

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

Locations

Country	Name	City	State
Italy	Ospedale SS Antonio Biagio e Cesare Arrigo	Alessandria
Italy	Università di Bari	Bari
Italy	Ospedale degli Infermi	Biella
Italy	Spedali Civili	Brescia
Italy	Ospedale Civitanova Marche	Civitanova Marche
Italy	AO Annunziata	Cosenza
Italy	Ospedale San Carlo	Cosenza
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	Ospedale San Raffaele	Milano
Italy	Centro oncologico modenese	Modena
Italy	AO Universitaria Paolo Giaccone	Palermo
Italy	Ospedale La Maddalena	Palermo
Italy	A O Universitaria di Parma	Parma
Italy	Ospedale Santa Maria della Misericordia	Perugia
Italy	Ausl Ravenna	Ravenna
Italy	Ospedale Bianchi Melacrino Morelli	Reggio Calabria
Italy	AO Santa Maria Nuova	Reggio Emilia
Italy	Ausl Rimini	Rimini
Italy	Istituto Regina Elena	Roma
Italy	Ospedale Sant'Eugenio	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	Ospedale Riuniti	Trieste
Italy	Santa Maria della Misericordia	Udine
Italy	Ospedale di circolo e Fondazione Macchi	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Italiana Linfomi ONLUS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of R-COMP in cardiopathic patients		2 years
Secondary	Response rates		1 year
Secondary	Progression free survival		2 years
Secondary	Overall Survival		3 years