Research Study of Visilizumab for Treatment of Glucocorticoid- Refractory Graft Versus Host Disease
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2003 by Facet Biotech.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Fred Hutchinson Cancer Research Center
Collaborator:
Facet Biotech
Information provided by:
Facet Biotech
ClinicalTrials.gov Identifier:
NCT00032279
First received: March 15, 2002
Last updated: June 23, 2005
Last verified: October 2003
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Graft-vs-Host Disease |
Drug: Visilizumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II, Multicenter Clinical Trial Evaluating the Use of Humanized Monoclonal Anti-CD3 Antibody Visilizumab(Nuvion) as Second-line Therapy for Glucocorticoid-Refractory, Acute Graft-Versus-Host Disease |
Resource links provided by NLM:
Further study details as provided by Facet Biotech:
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00032279
Locations
| 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, Florida | |
| H. Lee Moffitt Cancer Center & Research Institute | |
| Tampa, Florida, United States, 33612 | |
| United States, Indiana | |
| University Hospital | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| University of Massachusetts Medical School | |
| Worcester, Massachusetts, United States, 01605 | |
| United States, Missouri | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New York | |
| The New York Hospital Cornell Medical Center | |
| New York, New York, United States, 10021 | |
| Westchester Medical Center | |
| Valhalla, New York, United States, 10595 | |
| United States, North Carolina | |
| Duke University | |
| Durham, North Carolina, United States, 27705 | |
| United States, Ohio | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37232-6310 | |
| United States, Texas | |
| Baylor University Medical Center | |
| Dallas, Texas, United States, 75246 | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109 | |
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Facet Biotech
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00032279 History of Changes |
| Other Study ID Numbers: | 1589 |
| Study First Received: | March 15, 2002 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Graft vs Host Disease Immune System Diseases Glucocorticoids Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013