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

• Sponsor: University of Cologne (Other)
• Overall Status: Completed
• CT.gov ID: NCT00147875
• Collaborator: German Hodgkin's Lymphoma Study Group (Other), Eli Lilly and Company (Industry)
• Enrollment: 60
• Location: 1

Study Details

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.

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

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 Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• 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
• Study Start Date: Mar 1, 2004
• Actual Primary Completion Date: Jul 1, 2007

Outcome Measures

Primary Outcome Measures

1. Phase I: Dose-limiting toxicities and dose reductions []

2. Phase II: Treatment administration and complete response rate []

Secondary Outcome Measures

1. Toxicities []

2. Supportive care (RBCT need, antibiotic need) []

3. Early progression rate []

4. Overall survival []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 75 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Cologne	Cologne	NRW	Germany	50924

Sponsors and Collaborators

• University of Cologne
• German Hodgkin's Lymphoma Study Group
• Eli Lilly and Company

Investigators

• Principal Investigator: Andreas Engert, University of Cologne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00147875
• Other Study ID Numbers: PVAG elderly
• First Posted: Sep 7, 2005
• Last Update Posted: Sep 7, 2009
• Last Verified: Sep 1, 2009

• Keywords provided by , ,: Lymphoma; Gemcitabine; Advanced stages Hodgkin's lymphoma; Elderly
• Additional relevant MeSH terms: Lymphoma; Hodgkin Disease; Gemcitabine; Prednisone; Doxorubicin; Liposomal doxorubicin; Vinblastine

Study Results

No Results Posted as of Sep 7, 2009