Status:
COMPLETED
A Multi-centre Study of MBVD in Elderly and/or Cardiopathic Patients Affected by Hodgkin's Lymphoma (HL)
Lead Sponsor:
Fondazione Italiana Linfomi - ETS
Collaborating Sponsors:
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Conditions:
Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
STUDY POPULATION Patients affected by Hodgkin's lymphoma, any stage, older than 69 years. Patients affected by Hodgkin's Lymphoma with concomitant cardiopaty, older than 18 years. AIMS OF THE STUDY ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01523847
Start Date
November 1 2010
End Date
October 1 2013
Last Update
August 4 2016
Active Locations (26)
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1
Azienda Ospedaliera SS. Antonio e Biagio e C. Arrigo
Alessandria, Alessandria, Italy, 15121
2
Ospedale "A. Perrino"
Brindisi, Brindisi, Italy, 72100
3
Ematologia Ospedale Vito Fazzi
Lecce, Lecce, Italy, 73100
4
Ospedale Cardinale Giovanni Panico
Tricase, Lecce, Italy, 73039