A phase II multi-centre study of MBVD in elderly and/or cardiopathic patients affected by Hodgkin s lymphoma (HL). - ND
- Conditions
- elderly and/or cardiopathic patients affected by Hodgkin s lymphoma (HL).MedDRA version: 9.1Level: HLGTClassification code 10025319
- Registration Number
- EUCTR2009-013839-37-IT
- Lead Sponsor
- IIL INTERGRUPPO ITALIANO LINFOMI ONLUS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- 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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method