NCT00032292

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2002

Longer than P75 for phase_1

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2002

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2002

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

March 13, 2012

Status Verified

March 1, 2012

Enrollment Period

4.4 years

First QC Date

March 14, 2002

Last Update Submit

March 9, 2012

Conditions

Graft vs Host Disease

Interventions

VisilizumabDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (7)

City of Hope National Medical Center

Duarte, California, 91910, United States

Location

Stanford University Medical Center

Stanford, California, 94305-5623, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-6310, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

visilizumab

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2002

First Posted

March 18, 2002

Study Start

March 1, 2002

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

March 13, 2012

Record last verified: 2012-03

Locations

US(7)