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

NCT ID: NCT00147875

Last Updated: 2009-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hodgkin's Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Prednisone

Intervention Type DRUG

Vinblastine

Intervention Type DRUG

Doxorubicin (Adriamycin)

Intervention Type DRUG

Gemcitabine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

German Hodgkin's Lymphoma Study Group

OTHER

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

University of Cologne

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andreas Engert

Role: PRINCIPAL_INVESTIGATOR

University of Cologne

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Cologne

Cologne, North Rhine-Westphalia, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 21917759 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PVAG elderly

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.