This trial is active, not recruiting.

Condition graft-vs-host disease
Treatment visilizumab
Phase phase 2
Sponsor Fred Hutchinson Cancer Research Center
Collaborator Facet Biotech
Start date March 2002
Trial size 80 participants
Trial identifier NCT00032279, 1589, NCT00042744


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Eligibility Criteria

Male or female participants of any age.

- 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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in June 2005.
Information provided to ClinicalTrials.gov by Facet Biotech.