Clinical trial NCT01009970: Study With Rituximab, Cyclophosphamide, Doxorubicin Liposomal (Myocet®), Vincristine, Prednisone, (R-COMP) to Treat Non-Hodgkin's Lymphoma
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diffuse Large B-Cell Lymphoma
Keywords: Diffuse Large B-Cell Lymphoma
Lead sponsor: Fondazione Italiana Linfomi - ETS
Sponsor class: OTHER
First posted: 2009-11-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Feasibility of R-COMP in cardiopathic patients
timeFrame: 2 years
Secondary outcomes:
measure: Response rates
timeFrame: 1 year
measure: Progression free survival
timeFrame: 2 years
measure: Overall Survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: Ospedale SS Antonio Biagio e Cesare Arrigo
city: Bari
country: Italy
facility: Università di Bari
city: Biella
country: Italy
facility: Ospedale degli Infermi
city: Brescia
country: Italy
facility: Spedali Civili
city: Civitanova Marche
country: Italy
facility: Ospedale Civitanova Marche
city: Cosenza
country: Italy
facility: AO Annunziata
city: Cosenza
country: Italy
facility: Ospedale San Carlo
city: Lecce
country: Italy
facility: Ospedale Vito Fazzi
city: Meldola (FC)
country: Italy
facility: Istituto Scientifico Romagnolo per lo studio e la cura dei tumori (IRST)
city: Messina
country: Italy
facility: A O Papardo
city: Milano
country: Italy
facility: Ospedale Niguarda Cà Granda
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Modena
country: Italy
facility: Centro oncologico modenese
city: Palermo
country: Italy
facility: AO Universitaria Paolo Giaccone
city: Palermo
country: Italy
facility: Ospedale La Maddalena
city: Parma
country: Italy
facility: A O Universitaria di Parma
city: Perugia
country: Italy
facility: Ospedale Santa Maria della Misericordia
city: Ravenna
country: Italy
facility: Ausl Ravenna
city: Reggio Calabria
country: Italy
facility: Ospedale Bianchi Melacrino Morelli
city: Reggio Emilia
country: Italy
facility: AO Santa Maria Nuova
city: Rimini
country: Italy
facility: Ausl Rimini
city: Roma
country: Italy
facility: Istituto Regina Elena
city: Roma
country: Italy
facility: Ospedale Sant'Eugenio
city: Roma
country: Italy
facility: Università La Sapienza
city: Rozzano (MI)
country: Italy
facility: Clinica Humanitas
city: San giovanni Rotondo
country: Italy
facility: Casa sollievo della sofferenza
city: Sassari
country: Italy
facility: Università di Sassari
city: Siena
country: Italy
facility: Azienda Ospedaliera senese
city: Torino
country: Italy
facility: Ospedale San Giovanni Battista Molinette
city: Trieste
country: Italy
facility: Ospedale Riuniti
city: Udine
country: Italy
facility: Santa Maria della Misericordia
city: Varese
country: Italy
facility: Ospedale di circolo e Fondazione Macchi
Study officials:
affiliation: Centro di riferimento Oncologico di Aviano
name: Michele Spina, MD
role: STUDY_DIRECTOR
References: