NCT00806728

Study of MEDI-507 in With Steroid-Resistant Acute Graft-Versus-Host Disease

Phase I Study of MEDI-507 in the Treatment of Adult Patients With at Least Grade II Steroid-Resistant Acute Graft-Versus-Host Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A clinical trial to assess safety and two regimens of (MEDI-507) a drug given to stem cell and bone marrow recipients who have a mid-grade acute Graft-versus-Host Disease.

Detailed description

To assess the safety of two regimens of MEDI-507 administered to stem cell and bone marrow allograft recipients who have at least grade II acute GVHD and who have not achieved a satisfactory response to at least three days of corticosteroid therapy (2 mg/kg/day of methylprednisolone or its equivalent).

Conditions

• Cancer
• Graft-Versus-Host Disease

Interventions

Type	Name	Description
DRUG	MEDI-507	0.12 mg/kg of MEDI-507 given every third day for 4 doses followed by doses of normal saline on Days 16, 23, 30, and 37.
DRUG	MEDI-507	0.12 mg/kg of MEDI-507 given every third day for 4 doses followed by doses of MEDI-507 on Days 16, 23, 30, and 37.

Timeline

• Start date: 1998-05-01
• Primary completion: 1998-11-01
• Completion: 1998-12-01
• First posted: 2008-12-11
• Last updated: 2008-12-11

Locations

10 sites across 1 country: United States