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NCT00147875 Clinical Trial

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

Hodgkin's Disease Clinical Trial

Official title:
PVAG - Phase I/II Dose Finding Trial in Elderly Patients (> 60 Years) With Advanced Stages Hodgkin's Lymphoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00147875
Other study ID # PVAG elderly
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received September 2, 2005
Last updated September 4, 2009
Start date March 2004

Study information
Verified date September 2009
Source University of Cologne
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date
Est. primary completion date July 2007
Accepts healthy volunteers No
Gender Both
Age group 60 Years to 75 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Prednisone

• Vinblastine

• Doxorubicin (Adriamycin)

• Gemcitabine

Locations
Country Name City State
Germany University of Cologne Cologne NRW

Sponsors (3)
Lead Sponsor Collaborator
University of Cologne Eli Lilly and Company, German Hodgkin's Lymphoma Study Group

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Phase I: Dose-limiting toxicities and dose reductions
Primary Phase II: Treatment administration and complete response rate
Secondary Toxicities
Secondary Supportive care (RBCT need, antibiotic need)
Secondary Early progression rate
Secondary Overall survival
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