This study is NOT currently recruiting participants.
National Cancer Institute (NCI)
Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 18 Years Max Age: N/A
Referral Letter Required
Allogeneic hematopoietic cell transplantation; Ibrutinib; Systemic Therapy; Immunosuppressive Treatment; Glucocorticoid Therapy
Graft vs Host Disease
belumosudil (formerly kd025)
National Cancer Institute
Participants who have had an Allogeneic Hematopoietic Stem Cell Transplant may develop Chronic Graft Versus Host Disease (cGVHD). cGVHD occurs when donor bone marrow or stem cells attack the recipient. Researchers want to see if the drug belumosudil can block one of the chemical signals that lead to the immune reaction that causes cGVHD.
To test if belumosudil is a safe and effective treatment for cGVHD.
Participants ages 12 and older who have cGVHD and have been treated with at least 2 standard medications for it.
Participants will be screened with medical and medication histories. They will have a physical exam. They will have tests to measure lung and heart function. They will have blood and urine tests. They will answer questions about how well they are able to take care of themselves and how cGVHD is affecting their body and quality of life.
Eligible participants will be assigned to 1 of 2 treatment groups. They will take the study drug by mouth either once or twice a day. They will use a study drug diary. The treatment period will consist of 28-day cycles.
Participants will repeat the screening tests throughout the study. They will have many clinic visits.
Participants may have optional blood testing and have photographs taken to better understand the drug s effect on the body.
Participants will have a follow-up visit 28 days after they stop taking the study drug. After this visit, they will be contacted by phone, email, or postal mail every 12 weeks.
The study will last up to 4 years.
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Eligibility: -Participants must be greater than or equal to 18 years. -Participants must participate in the biospecimen collection companion study
-Participants must be greater than or equal to 18 years.
-Participants must participate in the biospecimen collection companion study
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