Clinical Trial Goal
To find out if the combination of axatilimab and steroids is safe and works well to treat chronic GVHD that has not yet been treated in children and adults
You may be able to join this trial if you:
- Are 12 years old or older
- Have recently been diagnosed with chronic GVHD that doctors consider moderate or severe
- Have not received any treatment for the chronic GVHD other than steroids for 1 week or less
- Disease the patient had a blood or marrow transplant (BMT) for has not come back (relapsed)
- Have not had more than one allogeneic (cells from a donor) blood or marrow transplant (BMT)
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Axatilimab is a monoclonal antibody that targets CSF1R in certain cells.
Steroids can include prednisone, methylprednisolone, or prednisolone that are standard treatments for GVHD.
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:
Steroids can include prednisone, methylprednisolone, or prednisolone that are standard treatments for GVHD.
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 – Axatilimab and steroids
- Group 2 – Placebo and steroids
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:
- Axatilimab - Group 1 only - Given as intravenous (IV) infusions
- Steroids - Given as IV infusions or as pills that you take by mouth
You may continue treatment for as long as the clinical trial doctors think it’s best for your health. You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for up to 3 years.
The Food and Drug Administration (FDA) has approved all of the drugs used in this trial for the treatment of chronic GVHD. Using them for adults and children who have not yet been treated is new and unproven.
Contacts
Incyte Corporation Call Center (US), 1.855.463.3463, medinfo@incyte.com
Incyte Corporation Call Center (ex-US), +800 00027423, eumedinfo@incyte.com
Locations
Sponsors
lead: Incyte Corporation
