Research Study of Visilizumab for Treatment of Acute Graft Versus Host Disease
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00032292 |
Recruitment Status
:
Completed
First Posted
: March 18, 2002
Last Update Posted
: March 13, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Graft vs Host Disease | Drug: Visilizumab | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 34 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | March 2002 |
Actual Primary Completion Date : | August 2006 |
Actual Study Completion Date : | August 2006 |


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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00032292
United States, California | |
City of Hope National Medical Center | |
Duarte, California, United States, 91910 | |
Stanford University Medical Center | |
Stanford, California, United States, 94305-5623 | |
United States, Missouri | |
Washington University School of Medicine | |
St. Louis, Missouri, United States, 63110 | |
United States, North Carolina | |
Duke University | |
Durham, North Carolina, United States, 27705 | |
United States, Tennessee | |
Vanderbilt University Medical Center | |
Nashville, Tennessee, United States, 37232-6310 | |
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
United States, Washington | |
Fred Hutchinson Cancer Research Center | |
Seattle, Washington, United States, 98109 |
Responsible Party: | Facet Biotech |
ClinicalTrials.gov Identifier: | NCT00032292 History of Changes |
Other Study ID Numbers: |
291-405 |
First Posted: | March 18, 2002 Key Record Dates |
Last Update Posted: | March 13, 2012 |
Last Verified: | March 2012 |
Additional relevant MeSH terms:
Graft vs Host Disease Immune System Diseases |