Spots Global Cancer Trial Database for Study of US-ATG-F to Prevent Chronic Graft Versus Host Disease (GVHD)
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Trial Identification
Brief Title: Study of US-ATG-F to Prevent Chronic Graft Versus Host Disease (GVHD)
Official Title: Phase 3 Study of US-ATG-F to Prevent Moderate to Severe Chronic GVHD in Adult Acute Myeloid Leukemia, Acute Lymphoid Leukemia, and Myelodysplastic Syndrome Patients After Allogeneic Stem Cell Transplantation From Unrelated Donors
Study ID: NCT01295710
Study Description
Brief Summary: The study objective is to compare the efficacy and safety of US-ATG-F as a supplement to standard of care prophylaxis versus standard of care prophylaxis alone in moderate to severe chronic GVHD-free survival.
Detailed Description: This study is randomized, prospective, double-blind, placebo-controlled, phase 3 study evaluating the prevention of moderate to severe chronic GVHD in patients undergoing bone marrow or peripheral blood stem cell transplantation from matched, unrelated donors for acute leukemia and myelodysplastic syndrome during the first year after transplant. Patients meeting all the inclusion and none of the exclusion criteria will be randomized (1:1). All patients will receive premedication and study drug 3 days prior to transplantation.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope, Duarte, California, United States
Stanford University Medical Center, BMT, Stanford, California, United States
University of Florida Shands Cancer Center, Gainesville, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
University of Chicago Medical Center, Chicago, Illinois, United States
Loyola University Medical Center, Maywood, Illinois, United States
University of Kansas Medical Center, Westwood, Kansas, United States
Tulane University Health Sciences Center, New Orleans, Louisiana, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Mayo Clinic, Rochester, Minnesota, United States
Washington University Medical Center, Saint Louis, Missouri, United States
Weill Cornell Medical Center, New York, New York, United States
University of North Carolina Hospitals, Chapel Hill, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Oregon Health and Science University, Portland, Oregon, United States
Penn State Hershey Cancer Institute, Hershey, Pennsylvania, United States
Abramson Cancer Center of the University at Perlman Center for Advanced Medicine, Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center, Vanderbilt Ingram Cancer Center, Nashville, Tennessee, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Texas Transplant Physician's Group, San Antonio, Texas, United States
University of Utah School of Medicine, Salt Lake City, Utah, United States
VA Puget Sound Healthcare System, Seattle, Washington, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Royal Melbourne Hospital, Parkville, Victoria, Australia
Contact Details
Name: Anne Kuan
Affiliation: Neovii Biotech
Role: STUDY_DIRECTOR
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