A Multi-centre Study of MBVD in Elderly and/or Cardiopathic Patients Affected by Hodgkin's Lymphoma (HL) — HD0803  

Hodgkin Lymphoma Clinical Trial

Official title: A Phase II Multi-centre Study of MBVD in Elderly and/or Cardiopathic Patients Affected by Hodgkin's Lymphoma (HL)

Status Completed

Clinical Trial 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 the conventional ABVD regimen.

Clinical Trial 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

• 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

• 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.

STUDY DESIGN Multi-centre phase II study SAMPLE SIZE 50 patients

STUDY PROCEDURES

• Histologic diagnosis of Hodgkin Lymphoma.

• Early Staging evaluation including:

• Blood tests

• CT, PET and bone marrow biopsy.

• Heart and lung function evaluation.

• Geriatric assessment.

• Quality of life evaluation.

• 2 MBVD courses

• 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-36Gy).

• 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 (30-36 Gy) is optional.

• Final restaging including:

• Blood tests

• CT, PET

• bone marrow biopsy if positive at baseline.

• Heart and lung function evaluation.

• Geriatric assessment.

• Quality of life evaluation

Follow up procedures will include:

1. a clinical and laboratory evaluation (with troponin, proBNP / BNP, cardiology visit, ECG and echocardiogram) every 6 months in the first 2 years, then annually.

2. CT scans will be planned annually.

3. Compilation of geriatric evaluation scales every 6 months in the first 2 years, then annually.

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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma

• NCT number: NCT01523847
• Study type: Interventional
• Source: Fondazione Italiana Linfomi ONLUS
• Status: Completed
• Phase: Phase 2
• Start date: November 2010
• Completion date: October 2013