Study of Bortezomib (Velcade) in Combination With Dexamethasone to Treat Patients With Relapsed Hodgkin's Lymphoma

July 9, 2008 updated by: University of Cologne

A Phase II Study of Bortezomib in Combination With Dexamethasone in Patients With Relapsed Hodgkin's Lymphoma

The primary objective of this study is to evaluate wether bortezomib and dexamethasone are active in patients with relapsed Hodgkin's lymphoma.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The proteasome-inhibitor bortezomib (Velcade) shows promising activity in various human lymphoma cell line. In addition, several studies in heavily pretreated patients with lymphoma showed also promising results.

Study Type

Interventional

Enrollment

37

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Cologne, NRW, Germany, 50924
        • University of Cologne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hodgkin's lymphoma
  • Second or higher relapse (first relapse if high-dose chemotherapy not possible)
  • Age >/= 18 years
  • No major organ dysfunction or intercurrent disorder
  • Written informed consent

Exclusion Criteria:

  • Pregnant or nursing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall response rate (complete and partial responses)

Secondary Outcome Measures

Outcome Measure
Toxicity
Overall survival
Duration of response
Event free survival
Treatment administration (dose-intensity, total dose)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
German Hodgkin's Lymphoma Study Group

Investigators

  • Principal Investigator: Andreas Engert, University of Cologne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Study Registration Dates

First Submitted

September 1, 2005

First Submitted That Met QC Criteria

September 2, 2005

First Posted (Estimate)

September 7, 2005

Study Record Updates

Last Update Posted (Estimate)

July 10, 2008

Last Update Submitted That Met QC Criteria

July 9, 2008

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • X05132

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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