Study of Prednisone, Vinblastine, Doxorubicin, and Gemcitabine in Elderly Patients With Advanced Stages Hodgkin's Lymphoma

PVAG - Phase I/II Dose Finding Trial in Elderly Patients (> 60 Years) With Advanced Stages Hodgkin's Lymphoma

The objectives of this study are to assess the feasibility and efficacy of a combination chemotherapy (PVAG) in elderly patients with advanced stages Hodgkin's lymphoma.

Gemcitabine shows promising activity in patients with relapsed lymphoma either administered as single agent or in combination with other cytotoxic agents. No trial to date evaluated its role in patients with primary Hodgkin's lymphoma. We therefore developed a three-weekly regimen based on the standard ABVD regimen.

Inclusion Criteria:

• Hodgkin's lymphoma (histologically proven)
• Clinical stage IIB (with risk factors bulky mediastinal mass and/or extranodal involvement), III, or IV
• No prior antitumor therapy
• Age 60 to 75 years
• WHO performance status 0-2
• Normal pulmonary function
• Written informed consent

Exclusion Criteria:

• The following histologies are excluded: lymphocyte predominant HD
• Leukocytes < 2,500/microL
• Platelets < 100,000/microL