Clinical trial · Interventional
A Multi-centre Study of MBVD in Elderly and/or Cardiopathic Patients Affected by Hodgkin's Lymphoma (HL)
A Phase II Multi-centre Study of MBVD in Elderly and/or Cardiopathic Patients Affected by Hodgkin's Lymphoma (HL)
NCT01523847CI-TRIAL-00023365HD0803completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MBVD (Myocet+BVD) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MBVD (Myocet+BVD)
- description
- 2 MBVD courses, after early restaging with PET scan (PET-2) The subsequent treatment will be planned as follows: * -Stage I and IIA patients will go on with 1 more course of MBVD (total of 3 courses) followed by involved field radiotherapy (30 Gy-36 Gy). * -Advanced stage (IIB-IV) patients will go on with 4 more courses of MBVD (total of 6 courses). Radiotherapy limited to bulky or non complete responder areas (30 Gy) is optional.
- interventionNames
- Drug: MBVD (Myocet+BVD)
Primary outcomes (2)
- measure
- Complete Response (CR) at the end of the chemotherapy program
- timeFrame
- 24 weeks
- description
- CR is defined according to the Cheson 2007 response criteria.
- measure
- Cardiac Toxicity during the chemotherapy program measured by CTCAE v.3
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.