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CSL Behring: Ph2/3 Randomized D-blinded Alpha-1 AntiTrypsin (AAT) in GVHD HCT - 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).

What is the Condition Being Studied?

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.

Age Group
Adults, Children

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

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
Cell Therapy and Hematologic Malignancies Specialist
Protocol Number
IRB:PRO00100988
NCT:NCT03805789
Phase
Phase II/III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698