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

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione Italiana Linfomi ONLUS
• Collaborator: Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
• Treatments: Doxorubicin

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