Spots Global Cancer Trial Database for Sirolimus/Tacrolimus Versus Tacrolimus/Methotrexate for Preventing Graft-Versus-Host Disease (GVHD) (BMT CTN 0402)
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Trial Identification
Brief Title: Sirolimus/Tacrolimus Versus Tacrolimus/Methotrexate for Preventing Graft-Versus-Host Disease (GVHD) (BMT CTN 0402)
Official Title: A Phase III Randomized, Multicenter Trial Comparing Sirolimus/Tacrolimus With Tacrolimus/Methotrexate as Graft-versus-Host Disease (GVHD) Prophylaxis After HLA-Matched, Related Peripheral Blood Stem Cell Transplantation (BMT CTN #0402)
Study ID: NCT00406393
Study Description
Brief Summary: The study is designed as a phase III, randomized, open label, multicenter, prospective, comparative trial of sirolimus and tacrolimus versus tacrolimus and methotrexate as graft-versus-host disease (GVHD) prophylaxis after human leukocyte antigen (HLA)-matched, related, peripheral blood stem cell transplantation in individuals with hematologic cancer. Participants will be stratified by transplant center and will be randomly assigned to the sirolimus/tacrolimus or tacrolimus/methotrexate arms at a 1:1 ratio.
Detailed Description: BACKGROUND: Stem cell transplantation is a standard therapy for acute and chronic leukemias and myelodysplastic disorders. A common problem that may occur after a stem cell transplant is a condition known as GVHD. The purpose of this study is to compare two combinations of medications to see which is better at preventing GVHD. The combinations of medications in this study are: * Sirolimus and tacrolimus * Methotrexate and tacrolimus Doctors want to know if one combination is better than the other or if they both have the same result. DESIGN NARRATIVE: Participants will receive one of the two conditioning regimens described in the protocol, at the discretion of the transplant physician. The transplant physician must choose among these regimens prior to the participant's assignment to the GVHD prophylaxis treatment. Conditioning regimens will vary by center, but will be the same for all participants at each center. Stem cell donors will donate peripheral blood stem cells according to local institutional practices. Peripheral blood stem cells will not be manipulated or T-depleted prior to administration. Standard post-transplant care will be administered. Participants will be randomly assigned to one of two GVHD prophylaxis regimens and will be followed for the endpoints of interest. Participants will be followed for 114 days post-randomization for evaluation of the primary endpoint, with additional follow-up for 2 years after transplantation for evaluation of secondary endpoints.
Eligibility
Minimum Age: 2 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope National Medical Center, Duarte, California, United States
UCSD Medical Center, La Jolla, California, United States
Stanford Hospital and Clinics, Stanford, California, United States
University of Florida College of Medicine (Shands), Gainesville, Florida, United States
Emory University, Atlanta, Georgia, United States
Indiana University Medical Center, Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
DFCI/Brigham & Women's Hospital, Boston, Massachusetts, United States
University of Michigan Medical Center, Ann Arbor, Michigan, United States
University of Minnesota, Minneapolis, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
Washington University/Barnes Jewish Hospital, Saint Louis, Missouri, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
University Hospitals of Cleveland/Case Western, Cleveland, Ohio, United States
Ohio State, Arthur G. James Cancer Hospital, Columbus, Ohio, United States
University of Oklahoma Medical Center, Oklahoma City, Oklahoma, United States
Oregon Health & Science University, Portland, Oregon, United States
University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
Texas Transplant Institute, San Antonio, Texas, United States
Virginia Commonwealth University/MCV Hospital, Richmond, Virginia, United States
University of Wisconsin Hospital & Clinics, Madison, Wisconsin, United States
Hopital Saint-Louis, Paris, , France
Contact Details
Name: Mary Horowitz, MD
Affiliation: Center for International Blood and Marrow Transplant Research
Role: STUDY_DIRECTOR
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