- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00147875
Study of Prednisone, Vinblastine, Doxorubicin, and Gemcitabine in Elderly Patients With Advanced Stages Hodgkin's Lymphoma
September 4, 2009 updated by: University of Cologne
PVAG - Phase I/II Dose Finding Trial in Elderly Patients (> 60 Years) With Advanced Stages Hodgkin's Lymphoma
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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NRW
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Cologne, NRW, Germany, 50924
- University of Cologne
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Phase I: Dose-limiting toxicities and dose reductions
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Phase II: Treatment administration and complete response rate
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Secondary Outcome Measures
Outcome Measure |
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Overall survival
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Toxicities
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Supportive care (RBCT need, antibiotic need)
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Early progression rate
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andreas Engert, University of Cologne
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2004
Primary Completion (Actual)
July 1, 2007
Study Registration Dates
First Submitted
September 2, 2005
First Submitted That Met QC Criteria
September 2, 2005
First Posted (Estimate)
September 7, 2005
Study Record Updates
Last Update Posted (Estimate)
September 7, 2009
Last Update Submitted That Met QC Criteria
September 4, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Hodgkin Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Gemcitabine
- Prednisone
- Doxorubicin
- Liposomal doxorubicin
- Vinblastine
Other Study ID Numbers
- PVAG elderly
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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