A Multi-centre Study of MBVD in Elderly and/or Cardiopathic Patients Affected by Hodgkin's Lymphoma (HL) (HD0803)

This study has been completed.
Sponsor:
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: November 14, 2013
Last verified: November 2013
  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


Enrollment: 50
Study Start Date: November 2010
Study Completion Date: October 2013
Primary Completion Date: October 2013 (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:

  • -Stage I and IIA patients will go on with 1 more course of MBVD (total of 3 courses) followed by involved field radiotherapy (30 Gy-36 Gy).
  • -Advanced stage (IIB-IV) patients will go on with 4 more courses of MBVD (total of 6 courses). Radiotherapy limited to bulky or non complete responder areas (30 Gy) is optional.
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+ occult carriers (AntiHBc+, HbsAg-, AntiHBs+/-) Lamivudine prophylaxis 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 bilirubin 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 comorbidities will be scored and recorded, but they are not, if isolated, a sufficient reason for exclusion.
  • Frail patients, defined according 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01523847

Locations
Italy
AOU Clinica di Ematologia Ospedali Riuniti Umberto I
Ancona, AN, Italy, 60126
UO Oncologia ASL 3 Presidio Ospedaliero "Nicola Giannettasio" di Rossano - ASP Cosenza
Rossano, Cosenza, Italy, 87067
Casa sollievo della Sofferenza
San Giovanni Rotondo, Foggia, Italy, 71013
Ospedale Cardinale Giovanni Panico
Tricase, Lecce, Italy, 73039
A.S.U.R. Zona Territoriale n°8 - Ospedale di Civitanova Marche U.O. Medicina Interna ed Ematologia
Civitanova Marche, Macerata, Italy, 62012
Centro di riferimento oncologico
Rionero in Volture, Potenza, Italy, 85028
SC Medicina trasfusionale ed Ematologia Ospedale civile di Ivrea
Ivrea, Torino, Italy, 10015
Azienda Ospedaliera SS. Antonio e Biagio e C. Arrigo
Alessandria, Italy, 15121
Centro di riferimento Oncologico
Aviano, Italy
IRCC Istituto Tumori
Bari, Italy
Università Policlinico
Bari, Italy
Policlinico S. Orsola Malpighi
Bologna, Italy
Spedali Civili
Brescia, Italy
Ospedale "A. Perrino"
Brindisi, Italy, 72100
Ospedale Businco
Cagliari, Italy
Policlinico Universitario Careggi
Firenze, Italy
Ospedale S Martino
Genova, Italy
Ematologia Ospedale Vito Fazzi
Lecce, Italy, 73100
Area Vasta Romagna e IRST
Meldola (FC), Italy
AO Azienda Ospedaliera Ospedali Riuniti "Papardo-Piemonte" Ematologia-
Messina, Italy, 98158
Dip. di Oncologia ed Ematologia Università di Modena e Reggio Emilia Policlinico - COM Centro Oncologico Modenese
Modena, Italy, 41100
Oncoematologia - A.O.U. Federico II
Napoli, Italy, 80131
Ospedale A. Cardarelli
Napoli, Italy
Università deli studi A. Avogadro
Novara, Italy
Policlinico Giaccone
Palermo, Italy, 90127
Azienda Ospedaliera V.Cervello
Palermo, Italy, 90146
Azienda Ospedaliero - Universitaria di Parma
Parma, Italy, 43100
Oncologia Policlinico S. Matteo
Pavia, Italy, 27100
Fondazione Policlinico San Matteo
Pavia, Italy
Ospedale Guglielmo da Saliceto
Piacenza, Italy, 29100
Osp. S. Maria delle Croci
Ravenna, Italy
Azienda Ospedaliera "Bianchi Melacrino Morelli"
Reggio Calabria, Italy, 89124
Ematologia Azienda Ospedaliera Arcispedale "S. Maria Nuova"
Reggio Emilia, Italy, 42100
Divisione di Oncologia Ospedale civile degli Infermi
Rimini, Italy, 47900
Università "La Sapienza"
Roma, Italy
U.O.C. Ematologia IRCCS Istituti Fisioterapici Ospitalieri
Roma, Italy, 00144
Ospedale S. Eugenio
Roma, Italy
Cattedra e Unità Operativa di Ematologia Azienda Ospedaliera Università Senese
Siena, Italy, 53100
Ospedale Santa Maria
Terni, Italy
Struttura Complessa di Ematologia PO TREVISO
Treviso, Italy, 31100
Azienda Ospedaliero - Universitaria di Udine
Udine, Italy
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: November 14, 2013
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Fondazione Italiana Linfomi ONLUS:
Hodgkin Lymphoma
Cardiopathic
elderly
Myocet

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 30, 2014