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Investigator(s):
Edward Cowen, M.D. Principal Investigator Phone: 301-496-4299 cowene@mail.nih.gov	Kristin Baird, M.D. Lead Associate Investigator Phone: 301-451-0391 kbaird@mail.nih.gov
Referral Contact(s):
Susan Booher, M.S., R.N. Research Nurse Phone: 301-402-1474 boohers@mail.nih.gov

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Primary Eligibility:

• Histologically confirmed sclerodermatous chronic graft-versus-host disease (ScGVHD), with or without fasciitis, meeting the following criteria:
• Diagnosis is confirmed by the principal investigator or lead associate investigator
• Manifested at least 100 days after allogeneic hematopoietic stem cell transplantation
• Must have restricting range of motion of at least one joint, with a minimum deficit of 25%
• ≥ 4 years of age
• Refractory to at least one treatment regimen for ScGVHD
• One prior regimen must have included systemic corticosteroids at the equivalent prednisone dosing of 1 mg/kg/day for 14 days
• Patients in whom calcineurin inhibitors or corticosteroids are medically contraindicated are eligible
• Patients who have had stabilization of disease on calcineurin inhibitors or steroids, but in whom these medications cannot be tapered without disease flare, are also eligible
• Stable or tapering immunosuppressive regimen for ≥ 1 month
• No prior imatinib mesylate or other tyrosine kinase inhibitor after stem cell transplantation
• Karnofsky performance status (PS) 60–100% (patients ≥ 16 years of age); Lansky PS 60–100% (patients < 16 years of age)
• ANC ≥ 1,000/μL (growth factor independent)
• Platelet count ≥ 50,000/μL (platelet transfusion and growth factor independent)
• Total bilirubin < 3 x upper limit of normal (ULN) in the absence of Gilbert syndrome
• ALT and AST < 5 x ULN
• Age-adjusted normal serum creatinine OR creatinine clearance ≥ 60 mL/min
• Normal cardiac function
• No medical condition that would preclude study participation
• No active malignancy requiring therapy, including brain metastases
• Not pregnant or nursing; fertile patients must use effective contraception during and for 6 months after completion of study therapy
• HIV, hepatitis C, and hepatitis B negative
• No hypersensitivity to imatinib mesylate
• Patients cannot be concurrently enrolled on another therapeutic trial for GVHD

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Treatment Plan:

• Patients receive oral imatinib mesylate once daily on Days 1–28
• Treatment repeats every 28 days for up to 6 months following maximal response or a total of 2 years in the absence of disease progression or unacceptable toxicity
• Patients undergo blood sample collection at baseline and periodically during study
• After completion of study therapy, patients are followed for up to 1 year

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.

Reviewed: 11/14/08
Updated: 12/17/08