drugset / Trial / NCT00574470

Anti Cytokine Combination Therapy With Daclizumab and Infliximab for Treatment of Steroid Refractory Acute GVHD

NCT00574470

Phase 4 Completed 3 enrolled University of Iowa
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to see whether serious graft versus host disease which is not well controlled with steroid treatment can be controlled with therapy with both daclizumab and infliximab. We hypothesize that a combination of daclizumab and infliximab will more effectively treat graft versus host disease than therapy with a single drug. The study also looks at whether chronic graft versus host disease develops, and survival at 6 and 9 months post-treatment.

Timeline

Start
2006-01
Primary completion
2007-11
Completion
2008-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Daclizumab Monoclonal antibody 1 mg/kg Intravenous
Subject Infliximab Monoclonal antibody 10 mg/kg Intravenous