Anti Cytokine Combination Therapy With Daclizumab and Infliximab for Treatment of Steroid Refractory Acute GVHD
NCT00574470 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3
Last updated 2017-02-20
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.
Conditions
- Graft vs Host Disease
Interventions
- DRUG
-
daclizumab, infliximab
Daclizumab 1 mg/kg IV days 1, 4, 8, 15 and 22. Infliximab 10 mg/kg IV days 1, 8, 15 and 22.
Sponsors & Collaborators
-
University of Iowa
lead OTHER
Principal Investigators
-
Margarida Silverman, MD · University of Iowa Hospitals
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-01-31
- Primary Completion
- 2007-11-30
- Completion
- 2008-08-31
Countries
- United States
Study Locations
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