Imatinib and Rituximab in Treating Cutaneous Sclerosis in Patients With Chronic Graft-Versus-Host Disease
Trial ID or NCT#
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.
A Randomized Phase II Study of Imatinib and Rituximab for Cutaneous Sclerosis After Allogeneic Hematopoietic Cell Transplantation
- - 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 - 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
- - 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 - Prior treatment of chronic GVHD with imatinib, rituximab, or any other monoclonal B-cell antibody (e.g. ofatumumab) - Receipt of imatinib within the previous 6 months for any indication - Receipt of any monoclonal B-cell antibody (e.g. rituximab, ofatumumab) within the previous 12 months for any indication - Treatment with anti-B-cell cellular therapy (e.g. chimeric antigen-receptor-engineered cells) at any time after transplant - Current treatment with extracorporeal photopheresis (ECP) at the time of enrollment - 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
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