CSL Behring: Ph2/3 Randomized D-blinded Alpha-1 AntiTrypsin (AAT) in GVHD HCT (Stem Cell Transplant) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to see if study drug called Alpha 1-antitrypsin (AAT) along with the current standard of care (tacrolimus or cyclosporine and methotrexate) can prevent graft versus-host disease (GVHD) better than the standard of care alone in patients getting hematopoietic cell transplant (HCT).
Graft-versus-host disease (GVHD)
Who Can Participate in the Study?
Adults who are undergoing HCT for hematological malignancies, including: leukemia, lymphoma, multiple myeloma, myelodysplastic syndrome, and myeloproliferative neoplasms and have planned myeloablative conditioning regimen.
What is Involved?
If you join choose to join this study, you will:
- Have a screening visit
- Get procedures to prepare your body for the transplant
- Have a physical exam and vital signs taken every day for the 5 days before you get the transplant and during study visits
- Have blood drawn
- Get a standard GVHD prevention treatment 3 days before you get the transplant
- Get your first dose of the study drug, AAT, the day before the transplant
- Be given the stem cells on transplant day
- Have study visits
- Be randomized (like the flip of a coin) to get the study drug AAT or Placebo for 8 weeks