HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT (Stem Cell Transplantation)

What is the Purpose of this Study?

We are doing this study to find out if an experimental drug called abatacept (the study drug) is a safe and effective option to help prevent graft-versus-host (GVHD) disease for people who get an omidubicel hematopoietic stem cell transplant to treat blood cancer. Omidubicel is a recently approved (2023) stem cell transplantation that uses modified umbilical cord blood. This new method of stem cell transplantation helps patients' immune systems recover more quickly after intensive chemotherapy.

What is the Condition Being Studied?

Graft-Versus-Host Disease (GVHD) Prevention

Who Can Participate in the Study?

Adults ages 18+ who:

  • Are candidates to receive allogeneic hematopoietic stem cell transplantation
  • Do not have a matched donor for their transplant

For more information, contact the study team at jennifer.tichon@duke.edu.

Age Group
Adults

What is Involved?

If you choose to join this study, you will start the study regimen shortly before you get your omidubicel transplant.

You will get your first dose of the study drug the day before your transplant. You will get 3 more doses of the study drug at the following times:

  • 5 days after your transplant
  • 2 weeks after your transplant
  • 4 weeks after your transplant

The study drug is given as an injection (shot) into a vein. In addition to the study drug, you will also take the drugs mycophenolate mofetil and tacrolimus as preventatives against GVHD.

Study Details

Full Title
A Pilot Trial of Abatacept Based Graft-Versus-Host Disease Prophylaxis Following Omidubicel Hematopoietic Cell Transplantation
Principal Investigator
Assistant Professor of Medicine
Protocol Number
IRB: PRO00116015
NCT: NCT06731504
Phase
Phase Pilot
ClinicalTrials.gov
Enrollment Status
NEW