Clinical Trial Detail

This randomized phase II trial is evaluating how well imatinib mesylate works compared to rituximab in treating cutaneous sclerosis in patients with chronic graft- versus-host disease (GVHD). Both imatinib and rituximab have been reported to decrease skin thickening and improve skin and joint flexibility in people with cutaneous sclerosis due to chronic GVHD

Ages Eligible for Study: 2 Years and older

Genders Eligible for Study: Both

- Cutaneous sclerosis after hematopoietic cell transplant (HCT) diagnosed no more than 18 months before study enrollment with sclerotic skin, morphea, myofascial involvement or joint contractures with a score of 2 or greater on the Vienna skin scale in any area, or a score of 5 or less at the shoulder, elbow or wrist, or a score of 3 or less at the ankle on the range-of-motion (ROM) assessment

- Stable doses of systemic immunosuppressive medications for a minimum of 4 weeks prior to the date of consent

- Receiving corticosteroids at a dose greater than required for treatment of adrenal insufficiency, unless the physician documents why steroids are contraindicated

- Age 2-99 years

- Karnofsky performance status >= 60% at enrollment

- All females of childbearing potential must have a negative serum or urine pregnancy test =< 7 days prior to starting study therapy

- All females of childbearing potential must agree to use a form of Food and Drug Administration (FDA) approved contraception from enrollment to one month after study treatment ends

- Subject has the ability to understand and willingness to sign a written informed consent document

Other eligibility criteria may apply.

- Total bilirubin > 1.5x upper limit of normal (ULN)

- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 x ULN

- Renal insufficiency (serum creatinine > 2.0 mg/dl)

- Platelets < 30,000/ul or absolute neutrophil count < 1500/ul

- Known hypersensitivity to Rituximab or other anti-B cell antibodies

- Known Imatinib intolerance or allergy

- Evidence of any active viral, bacterial, or fungal infection that is progressive despite appropriate treatment

- Known hepatitis B surface antigen positive

- Pregnant, lactating, or planning a pregnancy while in the study

- Distal extremity skin score 3 or higher as the only manifestation of sclerosis

- Treatment of chronic GVHD with either Imatinib or Rituximab, or receipt of Imatinib or Rituximab within the previous 6 months for any other indication

- History of psychiatric disorder that would interfere with normal participation in this study

- Inability or unwillingness of subject and/or parent guardian to provide informed consent or comply with study protocol

- Use of non-FDA approved drugs within 4 weeks of participation

- Patient with any condition that, in the opinion of the investigator, would interfere with the subject's ability to comply with the study requirements

- Patients with uncontrolled substance abuse

- Current treatment with sirolimus (patients may stop sirolimus on the day of enrollment; if randomized to imatinib, they should wait seven days before starting the study drug)

Other exclusion criteria may apply.