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.
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