PVAG - Phase I/II Dose Finding Trial in Elderly Patients (> 60 Years) With Advanced Stages Hodgkin's Lymphoma
60 Years
75 Years
Both
Hodgkin's Disease
Trial Information
PVAG - Phase I/II Dose Finding Trial in Elderly Patients (> 60 Years) 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Phase I: Dose-limiting toxicities and dose reductions
Principal Investigator
Andreas Engert
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Cologne
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
PVAG elderly
NCT ID:
NCT00147875
Start Date:
March 2004
Completion Date:
Related Keywords:
- Hodgkin's Disease
- Lymphoma
- Gemcitabine
- Advanced stages Hodgkin's lymphoma
- Elderly
- Hodgkin Disease
- Lymphoma
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