Featured Trial
Clinical Trial Goal
To find out if belumosudil is safe and works well to treat chronic GVHD in children, teens and young adults
You may be able to join this trial if you:
- Are 12 years old or older
- Have chronic GVHD that doctors consider moderate or severe
- Have not received and treatment for the chronic GVHD other than steroids
- Disease the patient had a blood or marrow transplant (BMT) for has not come back (relapsed)
- Have not been treated with belumosudil. Your doctor can tell you this
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Belumosudil is a tyrosine kinase inhibitor that blocks ROCK2 in certain cells.
Prednisone is a steroid that reduces inflammation.
In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you and the clinical trial doctors won’t know which group you’re in until after the trial is finished:
Prednisone is a steroid that reduces inflammation.
In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you and the clinical trial doctors won’t know which group you’re in until after the trial is finished:
- Group 1 – Belumosudil and prednisone
- Group 2 – Placebo and prednisone
Randomized means doctors will use a computer to assign you to either group. A computer assigns you by chance, like flipping a coin or drawing a name out of a hat. You, your doctor or the clinical trial doctor won’t have any control over which group you’ll be assigned. This means you won’t be able to choose your group.
You’ll get treatment in cycles that last 1 month. In each cycle, you'll get:
- Belumosudil – Group 1 only - A pill that you take by mouth 1 or 2 times each day
- Placebo - Group 2 only - A pill that you take by mouth 1 or 2 times each day
- Prednisone - A pill that you take by mouth
You may continue treatment for as long as the clinical trial doctors think it’s best for your health. The clinical trial doctors will check your health for up to 5 years.
The Food and Drug Administration (FDA) has approved belumosudil to treat chronic GVHD in patients who have tried other treatments. Using it with patients who have not tried other treatments for their chronic GVHD is new and unproven.
Contacts
Trial Transparency email recommended (Toll free for US & Canada), 800-633-1610, Contact-US@sanofi.com
Locations
Sponsors
lead: Sanofi
