Front Line Ibrutinib for Newly Diagnosed Chronic Graft-Versus Host Disease
Status:
Recruiting
Trial end date:
2024-06-28
Target enrollment:
Participant gender:
Summary
Background:
Chronic Graft Versus Host Disease (cGVHD) can occur after a person has had a stem cell or
bone marrow transplant. In cGVHD, the donor cells attack the recipient s body. Researchers
want to see if a drug called ibruntinib can block one of the proteins that lead to the immune
reaction that causes cGVHD.
Objective:
To see if ibrutinib as a first-line treatment can help people with newly diagnosed cGVHD.
Eligibility:
People age 18 and older with newly diagnosed moderate or severe cGVHD
Design:
Participants will be screened with
medical and medicine histories
physical exam and vital signs
electrocardiograms (to measure heart function)
assessment of their ability to perform daily activities
blood and urine tests
assessment of their general well-being.
Participants will visit the Clinical Center every 2 weeks for the first 2 months. Then they
will visit every 4 weeks.
Participants will take ibrutinib by mouth once every day of every cycle. One cycle is 28
days. Treatment will last up to 2 years. Participants will keep a medicine diary.
Participants will take tests to measure lung function. They may have computed tomography
scans of their chest. They will complete questionnaires about their symptoms and how cGVHD is
affecting their body and quality of life. They will repeat the screening tests.
Participants may have optional blood tests and/or skin biopsies to better understand the drug
s effect on the body.
Participants will be contacted by phone 30 days after treatment ends. They will also be
contacted once a year for 2 years to discuss how they are feeling and if they have taken any
other medicines to treat cGVHD.