Research Study of Visilizumab for Treatment of Acute Graft Versus Host Disease
This study has been completed.
Sponsor:
Facet Biotech
Information provided by (Responsible Party):
Facet Biotech
ClinicalTrials.gov Identifier:
NCT00032292
First received: March 14, 2002
Last updated: March 9, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Graft vs Host Disease |
Drug: Visilizumab |
Phase 1 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 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 |
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources:
Homologous Wasting Disease
Acute Graft Versus Host Disease
U.S. FDA Resources
Further study details as provided by Facet Biotech:
| Estimated Enrollment: | 34 |
| Study Start Date: | March 2002 |
| Study Completion Date: | August 2006 |
| Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
- 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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00032292
Please refer to this study by its ClinicalTrials.gov identifier: NCT00032292
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, 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 | |
Sponsors and Collaborators
Facet Biotech
More Information
| Responsible Party: | Facet Biotech |
| ClinicalTrials.gov Identifier: | NCT00032292 History of Changes |
| Other Study ID Numbers: | 291-405 |
| Study First Received: | March 14, 2002 |
| Last Updated: | March 9, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Graft vs Host Disease Immune System Diseases |
ClinicalTrials.gov processed this record on September 26, 2016