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

Phase 1

Completed

• Conditions: Hodgkin's Disease

• Registration Number: NCT00147875
• Lead Sponsor: University of Cologne

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2005-09-02
• Study First Submitted QC: 2005-09-02
• Study First Posted: 2005-09-07
• Primary Completion: 2007-07
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-04
• Last Update Posted: 2009-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Phase I: Dose-limiting toxicities and dose reductions
Phase II: Treatment administration and complete response rate

Secondary Outcome Measures

Name	Time	Method
Toxicities
Supportive care (RBCT need, antibiotic need)
Early progression rate
Overall survival

Trial Locations

Locations (1)

University of Cologne; 🇩🇪 Cologne, NRW, Germany