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Completed

NCT Number: NCT00147875

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

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.

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Key information

Conditions

Hodgkin's Disease Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Cologne

Cologne, North Rhine-Westphalia, 50924, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prednisone

Drug

Vinblastine

Drug

Doxorubicin (Adriamycin)

Drug

Gemcitabine

Drug

Primary outcomes

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

  2. Phase II: Treatment administration and complete response rate

Secondary outcomes

  1. Toxicities

  2. Supportive care (RBCT need, antibiotic need)

  3. Early progression rate

  4. Overall survival

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2007
First posted
Sep 7, 2005
Registry last updated
Sep 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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