CSL Behring: Ph2/3 Randomized D-blinded Alpha-1 AntiTrypsin (AAT) in GVHD HCT (Stem Cell Transplant)
What is the Purpose of this Study?
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
- 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
What is the Condition Being Studied?
Graft-versus-host disease (GVHD)
Who Can Participate in this 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.
For more information about who can join this study, please contact the study team at alexis.dalby@duke.edu.
Age Group
Both
Participating Institutions
What is Involved?
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).
Study Details
Full Title
A Phase 2/3, Multicenter, randOmized, Double-blind, placebo-controlled, stUdy to evaLuate the safety and efficacy of Alpha-1 AntiTrypsin for the prEvention of graft-versus-host disease in patients receiving hematopoietic cell transplant (MODULAATE Study)
Principal Investigator
Protocol Number
IRB:
PRO00100988
NCT:
NCT03805789
ClinicalTrials.gov
View on ClinicalTrials.gov