Status:
COMPLETED
Study of Prednisone, Vinblastine, Doxorubicin, and Gemcitabine in Elderly Patients With Advanced Stages Hodgkin's Lymphoma
Lead Sponsor:
University of Cologne
Collaborating Sponsors:
German Hodgkin's Lymphoma Study Group
Eli Lilly and Company
Conditions:
Hodgkin's Disease
Eligibility:
All Genders
60-75 years
Phase:
PHASE1
PHASE2
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 patien...
Eligibility Criteria
Inclusion
- 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
- The following histologies are excluded: lymphocyte predominant HD
- Leukocytes \< 2,500/microL
- Platelets \< 100,000/microL
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00147875
Start Date
March 1 2004
Last Update
September 7 2009
Active Locations (1)
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1
University of Cologne
Cologne, North Rhine-Westphalia, Germany, 50924