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

This study has been completed.
German Hodgkin's Lymphoma Study Group
Eli Lilly and Company
Information provided by:
University of Cologne Identifier:
First received: September 2, 2005
Last updated: September 4, 2009
Last verified: September 2009
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.

Condition Intervention Phase
Hodgkin's Disease Drug: Prednisone Drug: Vinblastine Drug: Doxorubicin (Adriamycin) Drug: Gemcitabine Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PVAG - Phase I/II Dose Finding Trial in Elderly Patients (> 60 Years) With Advanced Stages Hodgkin's Lymphoma

Resource links provided by NLM:

Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • Phase I: Dose-limiting toxicities and dose reductions
  • Phase II: Treatment administration and complete response rate

Secondary Outcome Measures:
  • Toxicities
  • Supportive care (RBCT need, antibiotic need)
  • Early progression rate
  • Overall survival

Enrollment: 60
Study Start Date: March 2004
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   60 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00147875

University of Cologne
Cologne, NRW, Germany, 50924
Sponsors and Collaborators
University of Cologne
German Hodgkin's Lymphoma Study Group
Eli Lilly and Company
Principal Investigator: Andreas Engert University of Cologne
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00147875     History of Changes
Other Study ID Numbers: PVAG elderly
Study First Received: September 2, 2005
Last Updated: September 4, 2009

Keywords provided by University of Cologne:
Advanced stages Hodgkin's lymphoma

Additional relevant MeSH terms:
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Liposomal doxorubicin
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on September 19, 2017