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Imatinib and Rituximab in Treating Cutaneous Sclerosis in Patients With Chronic Graft-Versus-Host Disease

Complete title: A Randomized Phase II Study of Imatinib and Rituximab for Cutaneous Sclerosis after Allogeneic Hematopoietic Cell Transplantation

Research Study Number       2343.00
Principal Investigator       Mary Flowers, MD
Phase       II

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Research Study Description

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.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 2 Years and older

Genders Eligible for Study: Both

- Diagnosis within the past 18 months of cutaneous sclerosis after hematopoietic cell transplant (HCT) with sclerotic skin, morphea, myofascial involvement or joint contractures; must have a score of 2 or greater on the Vienna skin scale in any area, or a range-of-motion (ROM) score of 5 or less at the shoulder, elbow or wrist, or 3 or less at the ankle

- No medication added for the treatment of graft versus host disease (GVHD) within the past 4 weeks

- 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.

Exclusions (conditions that would prevent participation in this study)

- 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

- Hepatitis B surface antigen positive

- Hepatitis B core antibody positive, unless hepatitis B virus (HBV) deoxyribonucleic acid (DNA) is undetectable

- Hepatitis C antibody positive, unless hepatitis C virus (HCV) ribonucleic acid (RNA) is undetectable

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

- Distal leg 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

Other exclusion criteria may apply.

Research Study Number       2343.00
Contact       Seattle Cancer Care Alliance Intake Office
Telephone       800-804-8824 / 206-288-1024

Chronic Graft Versus Host Disease (cGVHD)

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