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

Primary Purpose

Hodgkin's Disease

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Prednisone
Vinblastine
Doxorubicin (Adriamycin)
Gemcitabine
Sponsored by
University of Cologne
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hodgkin's Disease focused on measuring Lymphoma, Gemcitabine, Advanced stages Hodgkin's lymphoma, Elderly

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Cologne

Outcomes

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

Full Information

First Posted
September 2, 2005
Last Updated
September 4, 2009
Sponsor
University of Cologne
Collaborators
German Hodgkin's Lymphoma Study Group, Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00147875
Brief Title
Study of Prednisone, Vinblastine, Doxorubicin, and Gemcitabine in Elderly Patients With Advanced Stages Hodgkin's Lymphoma
Official Title
PVAG - Phase I/II Dose Finding Trial in Elderly Patients (> 60 Years) With Advanced Stages Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Cologne
Collaborators
German Hodgkin's Lymphoma Study Group, Eli Lilly and Company

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin's Disease
Keywords
Lymphoma, Gemcitabine, Advanced stages Hodgkin's lymphoma, Elderly

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Type
Drug
Intervention Name(s)
Vinblastine
Intervention Type
Drug
Intervention Name(s)
Doxorubicin (Adriamycin)
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Primary Outcome Measure Information:
Title
Phase I: Dose-limiting toxicities and dose reductions
Title
Phase II: Treatment administration and complete response rate
Secondary Outcome Measure Information:
Title
Toxicities
Title
Supportive care (RBCT need, antibiotic need)
Title
Early progression rate
Title
Overall survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Engert
Organizational Affiliation
University of Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cologne
City
Cologne
State/Province
NRW
ZIP/Postal Code
50924
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
21917759
Citation
Boll B, Bredenfeld H, Gorgen H, Halbsguth T, Eich HT, Soekler M, Markova J, Keller U, Graeven U, Kremers S, Geissler M, Trenn G, Fuchs M, von Tresckow B, Eichenauer DA, Borchmann P, Engert A. Phase 2 study of PVAG (prednisone, vinblastine, doxorubicin, gemcitabine) in elderly patients with early unfavorable or advanced stage Hodgkin lymphoma. Blood. 2011 Dec 8;118(24):6292-8. doi: 10.1182/blood-2011-07-368167. Epub 2011 Sep 13.
Results Reference
derived

Learn more about this trial

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

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