Purpose of this Study
This study lasts about six months. Before starting, participants will have health checks, including a physical exam, blood tests, and other assessments. Some participants may also have a pregnancy test.
Participants will be placed into one of two groups by chance. One group will receive a treatment called remestemcel along with a medicine called ruxolitinib. The other group will receive a placebo, which has no active medicine, along with ruxolitinib. Neither the participants nor the study doctors will know which group each person is in.
Remestemcel or the placebo is given through a vein twice a week for four weeks. Some people may receive extra weekly doses depending on how well they respond. Ruxolitinib is taken by mouth twice a day for up to 56 days. During the study, participants will have regular visits, blood tests, health checks, and quality of life questionnaires. The goal is to learn if this treatment can help people with severe graft versus host disease after a blood or bone marrow transplant.
Who Can Participate?
Eligibility
People can join this study if they are 18 years old or older and have a serious condition called acute graft versus host disease after a blood or bone marrow transplant. Their disease must be severe, Grade III or Grade IV, and must not have improved with steroid treatment. Researchers are studying new treatment options to help people whose graft versus host disease is not responding to standard medicines.
Age Range
18-100
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
The purpose of this study is to learn if adding a treatment called remestemcel to a medicine called ruxolitinib works better than using ruxolitinib alone for people who have severe graft versus host disease after a blood or bone marrow transplant. This condition happens when donated immune cells attack the body and does not get better with steroid treatment. Researchers will compare people who receive remestemcel and ruxolitinib with people who receive a placebo and ruxolitinib. The goal is to find out if the combination treatment can better control the disease and improve health after transplant.
Locations
Duke University Hospital
Visit Timing
Weekends
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Trial of remestemcel-L-rknd added to ruxolitinib for Grade III-IV Steroid-Refractory Acute Graft-Versus-Host Disease
Principal Investigator
Sanghee
Hong
Protocol Number
PRO00120527
NCT ID
NCT07568535
Phase
III
Enrollment Status
Pending Open to Enrollment