A phase II multi-centre study of MBVD in elderly and/or cardiopathic patients affected by Hodgkin s lymphoma (HL). - ND

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-013839-37-IT

Enrollment

Unknown

Registered

2010-03-29

Start date

2010-03-30

Completion date

Unknown

Last updated

2017-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

elderly and/or cardiopathic patients affected by Hodgkin s lymphoma (HL). MedDRA version: 9.1 Level: HLGT Classification code 10025319

Interventions

Trade Name: MYOCET Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Doxorubicin Concentration unit: mg/m2 milligram(s)/square meter Concentration type: equal Concentrati

Eligibility

Sex/Gender

All

Inclusion 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+ 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

Exclusion criteria

Exclusion criteria: - Lymphocyte predominance subgroup - Age 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

Design outcomes

Primary

Measure	Time frame
Main Objective: 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;Secondary Objective: To compare in a pair-match retrospective analysis the results obtained with MBVD with those obtained in patients comparable for clinical variables and treated with ABVD or with the reduced intensity VEPEMB schedule.;Primary end point(s): Evaluation of cardiac toxicity of MBVD in elderly and/or cardiopathic patients with Hodgkin s lymphoma at the end of treatment.	—

Measure

Time frame

Main Objective: 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;Secondary Objective: To compare in a pair-match retrospective analysis the results obtained with MBVD with those obtained in patients comparable for clinical variables and treated with ABVD or with the reduced intensity VEPEMB schedule.;Primary end point(s): Evaluation of cardiac toxicity of MBVD in elderly and/or cardiopathic patients with Hodgkin s lymphoma at the end of treatment.

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026