Imatinib and Rituximab in Treating Cutaneous Sclerosis in Patients With Chronic Graft-Versus-Host Disease
Trial ID or NCT#
NCT01309997
Status
NOT RECRUITING
Purpose
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.
Official Title
A Randomized Phase II Study of Imatinib and Rituximab for Cutaneous Sclerosis After Allogeneic Hematopoietic Cell Transplantation
Eligibility Criteria
Ages Eligible for Study: Older than 2 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
- * 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
Exclusion Criteria:
- * 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
Investigator(s)
Laura Johnston
Blood and marrow transplant specialist,
Blood and marrow transplant specialist,
Medical oncologist,
Hematologist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy), Emerita
Sally Arai
Blood and marrow transplant specialist,
Hematologist,
Blood and marrow transplant specialist
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Contact us to find out if this trial is right for you.
Contact
Physician Referrals
650-723-0822
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