16 Experimental Transplantation and Immunology Branch,. National Cancer .... Fecal Microbiota Transplant Is a Potentially Safe and. Effective Treatment for ...
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Abstracts / Biol Blood Marrow Transplant 22 (2016) S19eS481
University of Kansas Medical Center, Westwood, KS; 11 Department of Hematology and Medical Oncology, Winship Cancer Institute, Division of BMT, Emory University, Atlanta, GA; 12 The EMMES Corporation, Rockville, MD; 13 EMMES Corporation, Rockville, MD; 14 Hematology, Oncology and Transplantation, University of Minnesota, Minneapolis, MN; 15 Oregon Health & Science University, Portland, OR; 16 Experimental Transplantation and Immunology Branch, National Cancer Institute, NIH, Bethesda, MD; 17 Hematologic Malignancies, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA; 18 BMT CTN, Milwaukee, WI Primary Endpoint: To compare the proportion of subjects with cGVHD who had treatment success, defined as alive with complete or partial response (CR+PR) and no receipt of secondary systemic immunosuppressive therapy, at 6 months post randomization to PDN/SRL or PDN/SRL/CNI. Patients and Methods: Between April 2010 and December 2013, the BMT CTN conducted the phase II/III 0801 study of cGVHD designed with 87% likelihood of continuing to phase III if there was truly a 20% improvement in the 6 month CR+PR rates: accrual was stopped early for futility when 100 subjects were evaluable but all subjects were followed for later endpoints. Eligible candidates had classic or overlap chronic GVHD and were (A) previously untreated (
