A Phase 2 interventional study of MBVD (Myocet+BVD) in Hodgkin Lymphoma, sponsored by Fondazione Italiana Linfomi - ETS. Completed at 26 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-04.
Sponsored by Fondazione Italiana Linfomi - ETS · Phase 2, Interventional, and Treatment
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.
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
STUDY DESIGN Multi-centre phase II study SAMPLE SIZE 50 patients
STUDY PROCEDURES
Early Staging evaluation including:
The subsequent treatment will be planned as follows:
Final restaging including:
Follow up procedures will include:
MBVD will be scheduled as follows (4 weeks):
Myocet 25 mg/mq i.v. day 1 and 15 Bleomycin 10 mg/mq i.v. day 1 and 15 Vinblastine 6 mg/mq i.v. day 1 and 15 Dacarbazine 375 mg/mq i.v. day 1 and 15 Supportive treatment with G-CSF and/or Erythropoietin will be planned according to international guide-lines.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 50 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Fondazione Italiana Linfomi - ETS is the lead sponsor of 89 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: MBVD (Myocet+BVD)
MBVD will be scheduled as follows: Myocet 25 mg/mq i.v. day 1 and 15 Bleomycin 10 mg/mq i.v. day 1 and 15 Vinblastine 6 mg/mq i.v. day 1 and 15 Dacarbazine 375 mg/mq i.v. day 1 and 15
Also known as: MBVD
Complete Response (CR) at the end of the chemotherapy program
CR is defined according to the Cheson 2007 response criteria.
Time frame: 24 weeks
Cardiac Toxicity during the chemotherapy program measured by CTCAE v.3
Evaluation of Cardiac Toxicity during the chemotherapy program measured by CTCAE v.3
Time frame: 24 weeks
Cardiac toxicity of MBVD after two courses of MBVD measured by CTCAE v.3
Evaluation of cardiac toxicity of MBVD in elderly and/or cardiopathic patients with Hodgkin's lymphoma after two courses of MBVD.
Time frame: 8 weeks
Progression Free Survival (PFS)
PFS will be measured from the day of enrolment to the date of disease progression, relapse or death due to any cause
Time frame: 24 months
Relapse Free Survival (RFS) of patients entering complete remission
RFS is defined only for patients who achieve CR, and is measured from the date of attaining the disease-free state until the date of relapse or death from any cause
Time frame: 24 months
Overall Survival (OS)
OS will be measured from the day of enrolment to the date of relapse or death due to any cause
Time frame: 24 months
Change from the theoretical total amount of drug delivered in a one-week period (dose-intensity)
Proportion of dose-intensity delivered to patients
Time frame: 24 weeks
Change in cardiac markers during and at the end of chemotherapy
Evaluate Change in cardiac markers during and at the end of chemotherapy
Time frame: 24 weeks
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Fondazione Italiana Linfomi - ETS