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

University of Cologne

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hodgkin's Disease

Treatments: Drug: Vinblastine; Drug: Gemcitabine; Drug: Doxorubicin (Adriamycin); Drug: Prednisone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00147875

PVAG elderly

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 60 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)