A Multi-centre Study of MBVD in Elderly and/or Cardiopathic Patients Affected by Hodgkin's Lymphoma (HL) (HD0803)
This study is currently recruiting participants.
Verified May 2009 by Fondazione Italiana Linfomi ONLUS
Sponsor:
Fondazione Italiana Linfomi ONLUS
Collaborator:
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Information provided by (Responsible Party):
Fondazione Italiana Linfomi ONLUS
ClinicalTrials.gov Identifier:
NCT01523847
First received: June 22, 2011
Last updated: January 30, 2012
Last verified: May 2009
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Purpose
The study has the purpose to evaluate in elderly and/or cardiopathic HL patients, the cardiologic toxicity of the MBVD regimen, where liposomal doxorubicin (Myocet®) is substituted for doxorubicin in the conventional ABVD regimen.
| Condition | Intervention | Phase |
|---|---|---|
|
Hodgkin Lymphoma |
Drug: MBVD |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Multi-centre Study of MBVD in Elderly and/or Cardiopathic Patients Affected by Hodgkin's Lymphoma (HL) |
Resource links provided by NLM:
Further study details as provided by Fondazione Italiana Linfomi ONLUS:
Primary Outcome Measures:
- Complete Response (CR) at the end of the chemotherapy program [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]CR is defined according to the Cheson 2007 response criteria.
- Cardiac Toxicity during the chemotherapy program measured by CTCAE v.3 [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]Evaluation of Cardiac Toxicity during the chemotherapy program measured by CTCAE v.3
Secondary Outcome Measures:
- Cardiac toxicity of MBVD after two courses of MBVD measured by CTCAE v.3 [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]Evaluation of cardiac toxicity of MBVD in elderly and/or cardiopathic patients with Hodgkin's lymphoma after two courses of MBVD.
- Progression Free Survival (PFS) [ Time Frame: 24 months ] [ Designated as safety issue: No ]PFS will be measured from the day of enrolment to the date of disease progression, relapse or death due to any cause
- Relapse Free Survival (RFS) of patients entering complete remission [ Time Frame: 24 months ] [ Designated as safety issue: No ]RFS is defined only for patients who achieve CR, and is measured from the date of attaining the disease-free state until the date of relapse or death from any cause
- Overall Survival (OS) [ Time Frame: 24 months ] [ Designated as safety issue: No ]OS will be measured from the day of enrolment to the date of relapse or death due to any cause
- Change from the theoretical total amount of drug delivered in a one-week period (dose-intensity) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Proportion of dose-intensity delivered to patients
- Change in cardiac markers during and at the end of chemotherapy [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]Evaluate Change in cardiac markers during and at the end of chemotherapy
| Estimated Enrollment: | 50 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | August 2015 |
| Estimated Primary Completion Date: | August 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm1: MBVD
2 MBVD courses, after early restaging with PET scan (PET-2) The subsequent treatment will be planned as follows:
|
Drug: MBVD
MBVD will be scheduled as follows: Myocet 25 mg/mq i.v. day 1 and 15 Bleomycin 10 mg/mq i.v. day 1 and 15 Vinblastine 6 mg/mq i.v. day 1 and 15 Dacarbazine 375 mg/mq i.v. day 1 and 15 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically confirmed Hodgkin's lymphoma, except for nodular lymphocyte predominance subgroup.
- Previously untreated
- Age ≥ 70.
- Age> 18 in presence of cardiopathy according to inclusion criteria…
- Patients with HCV and HBV infection can be included. For patients HBV+ and occult carriers (AntiHBc+, HbsAg-, AntiHBs+/-) Lamivudine prophilaxis is mandatory.
- Life expectancy >3 months
- Informed consent.
- Staging with PET-CT.
- Preliminary geriatric assessment (ADL, IADL, co-morbidity and frailness scores).
Exclusion Criteria:
- Lymphocyte predominance subgroup
- Age < 70 (no cardiopathy)
- Age < 18 (with cardiopathy).
- HIV infection.
- Previous treatments for Hodgkin's lymphoma.
- Other concomitant or previous malignancies, with the exception of basal cell skin tumors, adequately treated carcinoma in situ of the cervix and any cancer that has been in complete remission for > 5 years.
- Renal failure (creatinine higher than twice the normal level) or liver disease (AST/ALT or bilirubine level higher than 2.5 times the normal level)
- Other clinical situations that contraindicate, to the judgment of investigators, the administration of a mild-dose chemotherapy. Isolated co-morbidities will be scored and recorded, but they are not, if isolated, a sufficient reason for exclusion.
- Frail patients, defined accordino to comorbidity scale: patients with 1 grade 4 comorbidity, or >3 grade 3 comorbidities, are excluded. (see appendix.6)
- Unresponsive sepsis
- Dementia
- Impossibility to subscribe the informed consent
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01523847
Contacts
| Contact: Valentina Lenti, PhD | 0131/206132 | vlenti@ospedale.al.it |
| Contact: Daniela Gioia, PhD | 0131/206066 | dgioia@ospedale.al.it |
Locations
| Italy | |
| Ospedale Cardinale Giovanni Panico | Recruiting |
| Tricase, Lecce, Italy, 73039 | |
| Contact: Linda Ferrara | |
| Principal Investigator: Vincenzo Pavone, MD | |
| Azienda Ospedaliera SS. Antonio e Biagio e C. Arrigo | Recruiting |
| Alessandria, Italy, 15121 | |
| Contact: Valentina Lenti, PhD 0131/206132 vlenti@ospedale.al.it | |
| Contact: Daniela Gioia, PhD 0131/206066 dgioia@ospedale.al.it | |
| Principal Investigator: Aessandro Levis, MD | |
| Divisione di Medicina A Ospedale Cardinal Massaia | Not yet recruiting |
| Asti, Italy | |
| Principal Investigator: Giorgio Ciravegna, MD | |
| Centro di riferimento Oncologico | Not yet recruiting |
| Aviano, Italy | |
| Principal Investigator: Michele Spina, MD | |
| IRCC Istituto Tumori | Not yet recruiting |
| Bari, Italy | |
| Principal Investigator: Attilio Guarini, MD | |
| Università Policlinico | Not yet recruiting |
| Bari, Italy | |
| Principal Investigator: Vincenzo Liso, MD | |
| Policlinico S. Orsola Malpighi | Not yet recruiting |
| Bologna, Italy | |
| Principal Investigator: Pierluigi Zinzani, MD | |
| Spedali Civili | Recruiting |
| Brescia, Italy | |
| Principal Investigator: Giuseppe Rossi, MD | |
| Ospedale Businco | Recruiting |
| Cagliari, Italy | |
| Principal Investigator: Emanuele Angelucci, PhD | |
| Università Cattolica Campobasso | Not yet recruiting |
| Campobasso, Italy | |
| Principal Investigator: Sergio Storti, MD | |
| Policlinico Universitario Careggi | Not yet recruiting |
| Firenze, Italy | |
| Principal Investigator: Alberto Bosi, MD | |
| Ospedale S Martino | Not yet recruiting |
| Genova, Italy | |
| Principal Investigator: Marco Gobbi, MD | |
| Area Vasta Romagna e IRST | Recruiting |
| Meldola (FC), Italy | |
| Principal Investigator: Dino Amadori, MD | |
| Istituto Europeo di Oncologia IEO | Not yet recruiting |
| Milano, Italy | |
| Principal Investigator: Giovanni Martinelli, MD | |
| Istituto Clinico Humanitas | Not yet recruiting |
| Milano, Italy | |
| Principal Investigator: Armando Santoro, MD | |
| Ospedale Niguarda Cà Granda | Not yet recruiting |
| Milano, Italy | |
| Principal Investigator: Livio Gargantini, MD | |
| Istituto Pascale | Not yet recruiting |
| Napoli, Italy | |
| Principal Investigator: Antonello Pinto, MD | |
| Ospedale A. Cardarelli | Not yet recruiting |
| Napoli, Italy | |
| Principal Investigator: Felicetto Ferrara, MD | |
| Università deli studi A. Avogadro | Not yet recruiting |
| Novara, Italy | |
| Principal Investigator: Gianluca Gaidano, MD | |
| Ospedale S. Francesco | Not yet recruiting |
| Nuoro, Italy | |
| Principal Investigator: Attilio Gabbas, MD | |
| Fondazione Policlinico San Matteo | Not yet recruiting |
| Pavia, Italy | |
| Principal Investigator: Ercole Brusamolino, MD | |
| Ospedale San Carlo | Not yet recruiting |
| Potenza, Italy | |
| Principal Investigator: MIchele Pizzuti, MD | |
| Osp. S. Maria delle Croci | Recruiting |
| Ravenna, Italy | |
| Principal Investigator: Alfonso Zaccaria, MD | |
| Azienda Ospedaliera "Bianchi Melacrino Morelli" | Recruiting |
| Reggio Calabria, Italy, 89124 | |
| Contact: Elisa Montechiarello | |
| Principal Investigator: Francesco Nobile, MD | |
| Sub-Investigator: Caterina Stelitano, MD | |
| Ospedale S. Eugenio | Not yet recruiting |
| Roma, Italy | |
| Principal Investigator: Elisabetta Abruzzese, MD | |
| Università "La Sapienza" | Recruiting |
| Roma, Italy | |
| Principal Investigator: Alessandro Pulsoni, MD | |
| Policlinico Università Tor-Vergata | Not yet recruiting |
| Roma, Italy | |
| Principal Investigator: Maria Cantonetti, MD | |
| Università Cattolica Policlinico Gemelli | Not yet recruiting |
| Roma, Italy | |
| Principal Investigator: Giuseppe Leone, MD | |
| AO Universitaria di Sassari | Not yet recruiting |
| Sassari, Italy | |
| Principal Investigator: Maurizio Longinotti, MD | |
| Ospedale Santa Maria | Recruiting |
| Terni, Italy | |
| Principal Investigator: Marina Liberati, MD | |
| Ematologia II OspedaleSan Giovanni Battista Molinette | Not yet recruiting |
| Torino, Italy | |
| Principal Investigator: Umberto Vitolo, MD | |
| Azienda Ospedaliero - Universitaria di Udine | Not yet recruiting |
| Udine, Italy | |
| Principal Investigator: Francesco Zaja, MD | |
| Ospedale di Circolo e Fondazione Macchi | Not yet recruiting |
| Varese, Italy | |
| Principal Investigator: Graziella Pinotti, MD | |
Sponsors and Collaborators
Fondazione Italiana Linfomi ONLUS
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Investigators
| Study Director: | Alessandro Levis, PhD | Azienda Ospedaliera SS Antonio, Biagio e Cesare Arrigo |
More Information
No publications provided
| Responsible Party: | Fondazione Italiana Linfomi ONLUS |
| ClinicalTrials.gov Identifier: | NCT01523847 History of Changes |
| Other Study ID Numbers: | IIL - HD0803, EudraCT Number 2009-013839-37 |
| Study First Received: | June 22, 2011 |
| Last Updated: | January 30, 2012 |
| Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
Keywords provided by Fondazione Italiana Linfomi ONLUS:
|
Hodgkin Lymphoma Cardiophatic elderly Myocet |
Additional relevant MeSH terms:
|
Hodgkin Disease Lymphoma Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013