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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lee, Stephanie
• Collaborator: National Cancer Institute (NCI)
• Treatments: Antibodies; Antibodies, Monoclonal; Imatinib Mesylate; Rituximab

Criteria

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