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)
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of Grades II-IV acute GVHD-free survival
Day 114
No
Ryotaro Nakamura, MD
Principal Investigator
City of Hope National Medical Center
United States: Federal Government
385
NCT00406393
November 2006
October 2015
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Mayo Clinic | Rochester, Minnesota 55905 |
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
City of Hope National Medical Center | Los Angeles, California 91010 |
University of Minnesota | Minneapolis, Minnesota 55455 |
Oregon Health & Science University | Portland, Oregon 97201 |
Duke University Medical Center | Durham, North Carolina 27710 |
University of Michigan Medical Center | Ann Arbor, Michigan 48104-0914 |
Emory University | Atlanta, Georgia 30322 |
University of Wisconsin Hospital & Clinics | Madison, Wisconsin 53792 |
Indiana University Medical Center | Indianapolis, Indiana 46202 |
Texas Transplant Institute | San Antonio, Texas 78229 |
UCSD Medical Center | La Jolla, California 92093 |
Stanford Hospital and Clinics | Stanford, California 94305 |
University of Florida College of Medicine (Shands) | Gainesville, Florida 32610 |
Washington University/Barnes Jewish Hospital | St. Louis, Missouri 63110 |
University Hospitals of Cleveland/Case Western | Cleveland, Ohio 44106 |
University of Oklahoma Medical Center | Oklahoma City, Oklahoma 73104 |
DFCI/Brigham & Women's Hospital | Boston, Massachusetts 02114 |
Virginia Commonwealth University/MCV Hospital | Richmond, Virginia 23298 |
Ohio State, Arthur G. James Cancer Hospital | Columbus, Ohio 43210 |