Study With Rituximab, Cyclophosphamide, Doxorubicin Liposomal (Myocet®), Vincristine, Prednisone, (R-COMP) to Treat Non-Hodgkin's Lymphoma
Overview[ - collapse ][ - ]
| Purpose | 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 | Diffuse Large B-Cell Lymphoma |
| Intervention | Drug: Rituximab Drug: Cyclophosphamide Drug: Vincristine Drug: Prednisone Drug: Doxorubicin |
| Phase | Phase 2 |
| Sponsor | Fondazione Italiana Linfomi ONLUS |
| Responsible Party | Fondazione Italiana Linfomi ONLUS |
| ClinicalTrials.gov Identifier | NCT01009970 |
| First Received | November 6, 2009 |
| Last Updated | October 12, 2011 |
| Last verified | October 2011 |
Tracking Information[ + expand ][ + ]
| First Received Date | November 6, 2009 |
|---|---|
| Last Updated Date | October 12, 2011 |
| Start Date | May 2010 |
| Estimated Primary Completion Date | May 2012 |
| Current Primary Outcome Measures | Feasibility of R-COMP in cardiopathic patients [Time Frame: 2 years] [Designated as safety issue: Yes] |
| Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
| Brief Title | 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 |
| 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 Provided |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Diffuse Large B-Cell Lymphoma |
| Intervention | 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 |
| Study Arm (s) | Experimental: 1 R-COMP |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 50 |
| Estimated Completion Date | May 2012 |
| Estimated Primary Completion Date | May 2011 |
| 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 |
| Gender | Both |
| Ages | 18 Months |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Daniela Denaro 0039-0131-206129 ddenaro@ospedale.al.it |
| Location Countries | Italy |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01009970 |
|---|---|
| Other Study ID Numbers | IIL-HEART01 |
| Has Data Monitoring Committee | No |
| Information Provided By | Fondazione Italiana Linfomi ONLUS |
| Study Sponsor | Fondazione Italiana Linfomi ONLUS |
| Collaborators | Not Provided |
| Investigators | Study Director: Michele Spina, MD Centro di riferimento Oncologico di Aviano |
| Verification Date | October 2011 |
Locations[ + expand ][ + ]
| Ospedale SS Antonio Biagio e Cesare Arrigo | Alessandria, Italy Principal Investigator: Alessandro Levis, MDRecruiting |
|---|---|
| Università di Bari | Bari, Italy Principal Investigator: Giorgina Specchia, MDNot yet recruiting |
| Ospedale degli Infermi | Biella, Italy Principal Investigator: Anna Tonso, MDNot yet recruiting |
| Spedali Civili | Brescia, Italy Principal Investigator: Giuseppe Rossi, MDNot yet recruiting |
| Ospedale Civitanova Marche | Civitanova Marche, Italy Principal Investigator: Riccardo Centurioni, MDNot yet recruiting |
| Ospedale San Carlo | Cosenza, Italy Principal Investigator: Attilio Olivieri, MDNot yet recruiting |
| AO Annunziata | Cosenza, Italy Not yet recruiting |
| Ospedale Vito Fazzi | Lecce, Italy Principal Investigator: Nicola Di Renzo, MDNot yet recruiting |
| Istituto Scientifico Romagnolo per lo studio e la cura dei tumori (IRST) | Meldola (FC), Italy Principal Investigator: Dino Amadori, MDNot yet recruiting |
| A O Papardo | Messina, Italy Principal Investigator: Maura Brugiatelli, MDNot yet recruiting |
| Ospedale Niguarda Cà Granda | Milano, Italy Principal Investigator: Livio Gargantini, MDNot yet recruiting |
| Ospedale San Raffaele | Milano, Italy Principal Investigator: Andres Ferreri, MDNot yet recruiting |
| Centro oncologico modenese | Modena, Italy Principal Investigator: Massimo Federico, MDRecruiting |
| AO Universitaria Paolo Giaccone | Palermo, Italy Principal Investigator: Salvatrice Mancuso, MDNot yet recruiting |
| Ospedale La Maddalena | Palermo, Italy Principal Investigator: Maurizio Musso, MDNot yet recruiting |
| A O Universitaria di Parma | Parma, Italy Principal Investigator: Vittorio Rizzoli, MDNot yet recruiting |
| Ospedale Santa Maria della Misericordia | Perugia, Italy Principal Investigator: Leonardo Flenghi, MDNot yet recruiting |
| Ausl Ravenna | Ravenna, Italy Principal Investigator: Alfonso Zaccaria, MDNot yet recruiting |
| Ospedale Bianchi Melacrino Morelli | Reggio Calabria, Italy Principal Investigator: Caterina Stelitano, MDNot yet recruiting |
| AO Santa Maria Nuova | Reggio Emilia, Italy Principal Investigator: Francesco Merli, MDNot yet recruiting |
| Ausl Rimini | Rimini, Italy Principal Investigator: Pier Paolo Fattori, MDNot yet recruiting |
| Ospedale Sant'Eugenio | Roma, Italy Principal Investigator: Elisabetta Abruzzese, MDNot yet recruiting |
| Università La Sapienza | Roma, Italy Principal Investigator: Maurizio Martelli, MDNot yet recruiting |
| Istituto Regina Elena | Roma, Italy Principal Investigator: Antonio Spadea, MDNot yet recruiting |
| Clinica Humanitas | Rozzano (MI), Italy Principal Investigator: Balzarotti Monica, MDNot yet recruiting |
| Casa sollievo della sofferenza | San giovanni Rotondo, Italy Principal Investigator: Nicola Cascavilla, MDNot yet recruiting |
| Università di Sassari | Sassari, Italy Principal Investigator: Maurizio Longinotti, MDNot yet recruiting |
| Azienda Ospedaliera senese | Siena, Italy Principal Investigator: Alberto Fabbri, MDNot yet recruiting |
| Ospedale San Giovanni Battista Molinette | Torino, Italy Principal Investigator: Umberto Vitolo, MDNot yet recruiting |
| Ospedale Riuniti | Trieste, Italy Principal Investigator: Gabriele Pozzato, MDNot yet recruiting |
| Santa Maria della Misericordia | Udine, Italy Principal Investigator: Francesco Zaja, MDNot yet recruiting |
| Ospedale di circolo e Fondazione Macchi | Varese, Italy Principal Investigator: Gabriella Pinotti, MDNot yet recruiting |