Imatinib Mesylate to Treat Skin Changes in Patients With Chronic Graft-Versus-Host Disease
Status:
Completed
Trial end date:
2020-02-26
Target enrollment:
Participant gender:
Summary
Background:
Chronic graft-versus-host disease (GVHD) is a common complication of stem cell transplant,
resulting from the donor's immune cells attacking the cells of the body of the recipient. One
effect of GVHD is fibrosis (scarring) of the skin that can lead to impaired function,
decreased quality of life and increased risk of death. This is known as sclerotic skin
changes of GVHD, or sclerodermatous graft versus host disease (ScGVHD).
Imatinib mesylate (Gleevec) is a drug that has been approved by the Food and Drug
Administration to treat cancer in humans and fibrosing conditions in animals.
Objectives:
To see if imatinib mesylate can improve ScGVHD and evaluate its effect on other GVHD symptoms
To assess the side effects of imatinib mesylate in patients with GVHD
To evaluate blood, body fluids and tissue samples in patients to try to better understand the
biology of ScGVHD
Eligibility:
Patients 4 years of age and older with ScGVHD
Design:
Initial treatment: Participants take imatinib mesylate tablets once a day for up to 6 months,
as long as their GVHD does not get worse and they do not develop unacceptable side effects of
the drug.
Evaluations: Participants are evaluated at 1, 3 and 6 months at the National Institutes of
Health (NIH) Clinical Center with procedures that may include the following:
Medical history and physical examination
Blood and urine tests
Lung function test
Skin biopsy
Magnetic resonance imaging (MRI) scan
Specialty consultations (e.g., physical or rehabilitative therapy, dentist, eye doctor,
dermatologist)
Electrocardiogram (EKG)
Echocardiogram (ultrasound test of the heart)
Muga scan (nuclear medicine test of the heart)
Quality-of-life questionnaires
Apheresis (procedure for collecting quantities of white blood cells)
Office visits with local physician once a week for 1 month, then once every 2 weeks for 5
months
Followup visits at National Institutes of Health (NIH) every 6 months for 1 year
Continuing treatment: Patients who improve continue to receive imatinib mesylate for up to 6
months after their best response and are followed for up to 2 years. Patients who continue to
respond or who become worse after stopping treatment may receive additional treatment for up
to 2 years.