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Graft Versus Host Disease

Imatinib Mesylate and Rituximab in Treating Cutaneous Sclerosis for Chronic GVHD (FHCRC-2343)
A Randomized Phase 2 Study of Imatinib and Rituximab for Cutaneous Sclerosis in Patients with Chronic Graft-Versus-Host Disease
Status Conditions Phase Study ID
Closed Chronic Graft Versus Host Disease (cGVHD) Phase II FHCRC-2343
NCT01309997
Summary

This randomized phase II trial is studying how well imatinib mesylate works compared to rituximab in treating cutaneous sclerosis in patients with chronic graft- versus-host disease. Imatinib mesylate may stop the growth of abnormal cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cell growth in different ways. Some block the ability of abnormal cells to grow and spread. Others find abnormal cells and help kill them or carry cell-killing substances to them. It is not yet known whether giving either imatinib mesylate or rituximab may kill more abnormal cells


Investigator
Mary Flowers, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)

Inclusion Criteria:

  • Diagnosis of cutaneous sclerosis (sclerotic skin, morphea, myofascial involvement or joint contractures) for not more than 12 months
  • Stable doses of other systemic immunosuppressive medications for at least 4 weeks prior to enrollment; if a patient is receiving extracorporeal photopheresis, they must be on the same treatment frequency for at least 8 week prior to enrollment
  • Receiving corticosteroids at a dose greater than required for treatment of adrenal insufficiency, unless the physician documents why steroids are contraindicated
  • Male and female, ages 2-99 years
  • Karnofsky performance status > 70%
  • If a female with reproductive potential, must have a negative serum or urine pregnancy test performed =< 7 days before starting study drug
  • If a female with reproductive potential, the subject agrees to use contraception from enrollment until one month after study treatment ends
  • Subject has the ability to understand and willingness to sign a written informed consent document

 

Exclusions (conditions that would prevent participation in this study)
  • Total bilirubin >1.5x the upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5x ULN
  • Renal insufficiency (serum creatinine >2.0 mg/dl)
  • Platelets < 30,000/ul or absolute neutrophil count < 1500/ul
  • Known life-threatening hypersensitivity to rituximab of other anti-B cell antibodies
  • Known imatinib intolerance or allergy
  • Active uncontrolled infection
  • Known hepatitis B surface antigen positive
  • Pregnant, lactating, or planning a pregnancy while on study
  • Distal extremity skin score 3 or higher as the only manifestation of sclerosis
  • Treatment of chronic GVHD with imatinib or rituximab, or receipt of either drug within the previous 6 months for any other indication
  • History of psychiatric disorder that would interfere with normal participation in the study
  • Inability or unwillingness to provide informed consent and comply with study procedures
  • Use of non-FDA-approved drugs within 4 weeks of enrollment
  • Any condition that, in the opinion of the investigator, would interfere with the subject's ability to comply with study requirements
  • Uncontrolled substance abuse
  • Current treatment with sirolimus
Last Updated
September 10, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.