Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01009970
Recruitment Status : Unknown
Verified October 2011 by Fondazione Italiana Linfomi ONLUS.
Recruitment status was:  Recruiting
First Posted : November 9, 2009
Last Update Posted : October 13, 2011
Sponsor:
Information provided by (Responsible Party):
Fondazione Italiana Linfomi ONLUS

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.

Condition or disease Intervention/treatment Phase
Diffuse Large B-Cell Lymphoma Drug: Rituximab Drug: Cyclophosphamide Drug: Vincristine Drug: Prednisone Drug: Doxorubicin Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2010
Actual Primary Completion Date : May 2011
Estimated Study Completion Date : May 2012


Arm Intervention/treatment
Experimental: 1
R-COMP
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




Primary Outcome Measures :
  1. Feasibility of R-COMP in cardiopathic patients [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Response rates [ Time Frame: 1 year ]
  2. Progression free survival [ Time Frame: 2 years ]
  3. Overall Survival [ Time Frame: 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01009970


Contacts
Layout table for location contacts
Contact: Daniela Denaro 0039-0131-206129 ddenaro@ospedale.al.it

Locations
Layout table for location information
Italy
Ospedale SS Antonio Biagio e Cesare Arrigo Recruiting
Alessandria, Italy
Principal Investigator: Alessandro Levis, MD         
Università di Bari Not yet recruiting
Bari, Italy
Principal Investigator: Giorgina Specchia, MD         
Ospedale degli Infermi Not yet recruiting
Biella, Italy
Principal Investigator: Anna Tonso, MD         
Spedali Civili Not yet recruiting
Brescia, Italy
Principal Investigator: Giuseppe Rossi, MD         
Ospedale Civitanova Marche Not yet recruiting
Civitanova Marche, Italy
Principal Investigator: Riccardo Centurioni, MD         
AO Annunziata Not yet recruiting
Cosenza, Italy
Ospedale San Carlo Not yet recruiting
Cosenza, Italy
Principal Investigator: Attilio Olivieri, MD         
Ospedale Vito Fazzi Not yet recruiting
Lecce, Italy
Principal Investigator: Nicola Di Renzo, MD         
Istituto Scientifico Romagnolo per lo studio e la cura dei tumori (IRST) Not yet recruiting
Meldola (FC), Italy
Principal Investigator: Dino Amadori, MD         
A O Papardo Not yet recruiting
Messina, Italy
Principal Investigator: Maura Brugiatelli, MD         
Ospedale Niguarda Cà Granda Not yet recruiting
Milano, Italy
Principal Investigator: Livio Gargantini, MD         
Ospedale San Raffaele Not yet recruiting
Milano, Italy
Principal Investigator: Andres Ferreri, MD         
Centro oncologico modenese Recruiting
Modena, Italy
Principal Investigator: Massimo Federico, MD         
AO Universitaria Paolo Giaccone Not yet recruiting
Palermo, Italy
Principal Investigator: Salvatrice Mancuso, MD         
Ospedale La Maddalena Not yet recruiting
Palermo, Italy
Principal Investigator: Maurizio Musso, MD         
A O Universitaria di Parma Not yet recruiting
Parma, Italy
Principal Investigator: Vittorio Rizzoli, MD         
Ospedale Santa Maria della Misericordia Not yet recruiting
Perugia, Italy
Principal Investigator: Leonardo Flenghi, MD         
Ausl Ravenna Not yet recruiting
Ravenna, Italy
Principal Investigator: Alfonso Zaccaria, MD         
Ospedale Bianchi Melacrino Morelli Not yet recruiting
Reggio Calabria, Italy
Principal Investigator: Caterina Stelitano, MD         
AO Santa Maria Nuova Not yet recruiting
Reggio Emilia, Italy
Principal Investigator: Francesco Merli, MD         
Ausl Rimini Not yet recruiting
Rimini, Italy
Principal Investigator: Pier Paolo Fattori, MD         
Istituto Regina Elena Not yet recruiting
Roma, Italy
Principal Investigator: Antonio Spadea, MD         
Ospedale Sant'Eugenio Not yet recruiting
Roma, Italy
Principal Investigator: Elisabetta Abruzzese, MD         
Università La Sapienza Not yet recruiting
Roma, Italy
Principal Investigator: Maurizio Martelli, MD         
Clinica Humanitas Not yet recruiting
Rozzano (MI), Italy
Principal Investigator: Balzarotti Monica, MD         
Casa sollievo della sofferenza Not yet recruiting
San giovanni Rotondo, Italy
Principal Investigator: Nicola Cascavilla, MD         
Università di Sassari Not yet recruiting
Sassari, Italy
Principal Investigator: Maurizio Longinotti, MD         
Azienda Ospedaliera senese Not yet recruiting
Siena, Italy
Principal Investigator: Alberto Fabbri, MD         
Ospedale San Giovanni Battista Molinette Not yet recruiting
Torino, Italy
Principal Investigator: Umberto Vitolo, MD         
Ospedale Riuniti Not yet recruiting
Trieste, Italy
Principal Investigator: Gabriele Pozzato, MD         
Santa Maria della Misericordia Not yet recruiting
Udine, Italy
Principal Investigator: Francesco Zaja, MD         
Ospedale di circolo e Fondazione Macchi Not yet recruiting
Varese, Italy
Principal Investigator: Gabriella Pinotti, MD         
Sponsors and Collaborators
Fondazione Italiana Linfomi ONLUS
Investigators
Layout table for investigator information
Study Director: Michele Spina, MD Centro di riferimento Oncologico di Aviano

Layout table for additonal information
Responsible Party: Fondazione Italiana Linfomi ONLUS
ClinicalTrials.gov Identifier: NCT01009970     History of Changes
Other Study ID Numbers: IIL-HEART01
2009-012143-42
First Posted: November 9, 2009    Key Record Dates
Last Update Posted: October 13, 2011
Last Verified: October 2011
Keywords provided by Fondazione Italiana Linfomi ONLUS:
Diffuse Large B-Cell Lymphoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Prednisone
Cyclophosphamide
Rituximab
Doxorubicin
Liposomal doxorubicin
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors