Thymoglobulin, Sirolimus and Mycophenolate Mofetil for Prevention of Acute GVHD Following Allogeneic Hematopoietic Stem Cell Transplantation
Rabbit anti-thymocyte globulin (rATG), sirolimus, and mycophenolate mofetil (MMF) are all
designed to prevent GVHD.
If you are found to be eligible to take part in this study, you will receive rATG through a
needle in your vein over 3-4 hours on each of the 4 days before the stem cell transplant.
Beginning 2 days before the transplant, you will take sirolimus by mouth once per day. You
will continue to receive sirolimus until 90 days after the transplant. Beginning on Day 60,
you will start taking increasingly lower doses of the study drug. This is done so you can
taper down slowly, and be off of the drug on Day 90.
Beginning on the day of the transplant, you will take MMF by mouth 2 times a day. You will
continue to take MMF until 27 days after the transplant.
Every week (for the first 90-100 days after the transplant) you will have study visits. At
this visit, you will have a physical exam. Blood (about 1-2 tablespoons) will be drawn for
You will remain on study for up to 90 days after transplantation. You will be taken off
study if intolerable side effects occur.
Starting on Day 90 after the transplant, you will continue to follow up with your transplant
doctor at least every 3 months through 1 year after the transplant. During these visits you
will have physical exams. Blood (about 1-2 tablespoons) will be drawn for routine tests.
Your doctor may request additional testing.
This is an investigational study. RATG, sirolimus, and MMF are all FDA approved for their
use in the transplantation of solid organs (like kidney and liver). All 3 drugs are
commercially available. This particular combination and dose schedule is considered
investigational. Up to 30 patients will take part in this study. All will be enrolled at
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Efficacy failure defined as a participants who had either grade 3-4 acute graft-versus-host disease (aGVHD) or treatment related mortality (TRM) within 100 days post transplant. Failure Rate calculated as (# of failures) / (# participants evaluated). Physical exam and bloodwork every week (for the first 90-100 days after the transplant).
Baseline to 100 days post transplant
Amin Alousi, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|