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.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are candidates to receive allogeneic hematopoietic stem cell transplantation
- Do not have a matched donor for their transplant
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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
Locations
Duke University Hospital
Visit Timing
Weekdays
Weekends
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Pilot Trial of Abatacept Based Graft-Versus-Host Disease Prophylaxis Following Omidubicel Hematopoietic Cell Transplantation
Principal Investigator
Sanghee
Hong
Protocol Number
PRO00116015
NCT ID
NCT06731504
Phase
Pilot
Enrollment Status
Pending Open to Enrollment