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

Not Recruiting

Trial ID: NCT01309997


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

Stanford Investigator(s)

Laura Johnston
Laura Johnston

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Sally Arai
Sally Arai

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)


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

   - 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


biological: rituximab

drug: Imatinib mesylate

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
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