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

• 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

• 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

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.

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