Research Study of Visilizumab for Treatment of Acute Graft Versus Host Disease

March 9, 2012 updated by: Facet Biotech

A Phase I/II, Open-Label, Dose-Escalation, Pilot Study to Evaluate Safety and Preliminary Efficacy of Visilizumab as Primary Therapy for Acute Graft-Versus-Host Disease After Hematopoietic Cell Transplantation

The purpose of this Phase I/II, open-label, dose-escalation study is to evaluate an investigational monoclonal antibody administered as a first-line therapy to patients with acute, Grade II, III, or IV graft-versus-host disease (GVHD). Patients will be eligible for enrollment within 24 hours of beginning standard steroid treatment. The research is being conducted at up to 10 clinical research sites in the US.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A Phase I/II, open-label, dose-escalation pilot study designed to obtain preliminary safety, pharmacokinetic (PK) and efficacy information on visilizumab administered as a first-line therapy to patients with acute, Grade II, III, or IV graft-versus-host disease (GVHD). It is anticipated that up to 34 patients at up to 10 study centers could be eligible for enrollment in this study. Patients will be eligible for enrollment within 24 hours of beginning standard steroid treatment (2 mg/kg of methylprednisolone IV, or 10 mg/kg hydrocortisone IV, per day). Steroids will be rapidly tapered over one week following visilizumab administration.

Study Type

Interventional

Enrollment

34

Phase

  • Phase 2
  • Phase 1

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

  • United States
    • California
      • Duarte, California, United States, 91910
        • City of Hope National Medical Center
      • Stanford, California, United States, 94305-5623
        • Stanford University Medical Center
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University
    • Tennessee
      • Nashville, Tennessee, United States, 37232-6310
        • Vanderbilt University Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • Patients who develop Grade II, III, or IV acute GVHD following allogeneic hematopoietic cell transplantation
  • Patients receiving GVHD prophylaxis including cyclosporine or tacrolimus
  • Clinical findings: skin thickening, joint contraction, oral ulceration, diarrhea.
  • Patients with an onset date of acute GVHD that is less than or equal to 100 days posttransplant.

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)

Collaborators and Investigators

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

Sponsor

Facet Biotech

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, 2002

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

March 14, 2002

First Submitted That Met QC Criteria

March 15, 2002

First Posted (Estimate)

March 18, 2002

Study Record Updates

Last Update Posted (Estimate)

March 13, 2012

Last Update Submitted That Met QC Criteria

March 9, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 291-405

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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