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

Completed · Phase 2

Conditions studied: Graft Versus Host Disease, Systemic Scleroderma

In brief

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.

Key facts

Study ID

NCT01309997

Run by

Lee, Stephanie

People needed

72

Starts

2011-03-01

Expected to finish

2015-12-01

Last updated by the study team

2016-06-15

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• Stanford University Hospitals and Clinics — Stanford, California, United States
• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Weill Cornell Medical College — New York, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
• Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — Seattle, Washington, United States
• Froedtert and the Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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