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Research Study of Visilizumab for Treatment of Glucocorticoid- Refractory Graft Versus Host Disease

NCT ID: NCT00032279

Last Updated: 2005-06-24

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

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Brief Summary

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The purpose of this phase II study is to evaluate an investigational monoclonal antibody for the treatment of glucocorticoid-refractory Graft Versus Host Disease (GVHD). Patients diagnosed with GVHD who have not responded satisfactorily to, or are intolerant of, treatment with standard agents will be considered for entry. Patients will be allowed to continue on their other immunosuppressive drugs at stable doses during the trial. The research is being conducted at up to 20 clinical research sites in the US.

Detailed Description

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Conditions

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Graft-vs-Host Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Visilizumab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Grade II to IV GVHD
* Clinical findings: skin thickening, joint contraction, oral ulceration, diarrhea.
* History of allogeneic hematopoietic cell transplant (HCT).
* Patients must have failed to respond or clearly progress to previous therapy on or before day +100 posttransplant.
* Patients must have adequate renal, hepatic, cardiac function and hematologic values
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Facet Biotech

INDUSTRY

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Locations

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City of Hope National Medical Center

Duarte, California, United States

Site Status

Stanford University Medical Center

Stanford, California, United States

Site Status

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, United States

Site Status

University Hospital

Indianapolis, Indiana, United States

Site Status

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

University of Massachusetts Medical School

Worcester, Massachusetts, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

The New York Hospital Cornell Medical Center

New York, New York, United States

Site Status

Westchester Medical Center

Valhalla, New York, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Baylor University Medical Center

Dallas, Texas, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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1589

Identifier Type: -

Identifier Source: org_study_id

NCT00042744

Identifier Type: -

Identifier Source: nct_alias