BMT CTN Protocol 0801
A Phase II/III Randomized, Multicenter Trial Comparing Sirolimus plus Prednisone, and Sirolimus/Calcineurin Inhibitor plus Prednisone for the Treatment of Chronic Graft-versus-Host Disease
Below are protocol-related documents, which may be periodically updated.
- Protocol synopsis and schema, version 6.0 dated July 9, 2012
- Protocol, version 6.0 dated July 9, 2012
- Summary of Changes between version 5.0 and version 6.0
- Consent and assent , version 6.0 dated July 9, 2012
- Frequently Asked Questions
- Participating centers
- This study is posted on clinicaltrials.gov as NCT01106833
- Key Personnel
Protocol co-Chair: Paul Carpenter, MD, BS (206-667-5191) pcarpent@fhcrc.org
Protocol co-Chair: Mukta Arora, MD arora005@umn.edu
Protocol Officer: Marcelo Pasquini, MD (414-805-0700) mpasquin@mcw.edu
Protocol Coordinator: Kelly O'Brien (301-251-1161) kobrien@emmes.com
Medical Monitor: Bipin Savani bipin.savani@vanderbilt.edu
“How to Conduct a Comprehensive Chronic GVHD Assessment” is an instructional guide for centers participating in the BMT CTN cGVHD 0801 protocol. The video also may serve as a tool to help obtain greater impartiality for clinical research trials focusing on cGVHD, and provides a more definitive method for assessing patients with cGVHD.
The BMT CTN 0801 study closed to new patient accrual on December 9, 2013.
