A Pilot Study of Imatinib Mesylate in Steroid Refractory Chronic Graft Versus Host Disease

To determine if subjects with steroid refractory cGVHD can tolerate imatinib mesylate and whether their cGVHD responds to imatinib mesylate.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : Imatinib

Phase: Phase 1

Eligibility

Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

A. Subject has cGVHD requiring systemic therapy occurring >100 days after hematopoietic cell transplant diagnosed with at least one diagnostic feature from Appendix A. B. Subject has active cGVHD with either: 1. Persistent steroid dependence defined as the inability to taper steroid treatment to less than 0.25 mg/kg/d prednisone or its equivalent for at least 3 months 2. Progression of cGVHD signs and symptoms on steroid therapy equivalent to prednisone 0.5 mg/kg/d for at least 1 month. C. Subject has at least one of the following manifestations with which to follow progression of disease or response to imatinib: 1. Skin changes (rash, sclerosis, fasciitis, or ulceration) 2. Abnormal eye wetness <= 5 mm as measured by Schirmer's test 3. Oral mucosal changes (erythema, lichenoid changes, ulcers, or mucoceles) 4. Thrombocytopenia (platelets <150,000/uL). 5. Abnormal liver function testing (alkaline phosphatase, AST, ALT, or total bilirubin > ULN). 6. Bronchiolitis obliterans (diagnosed by a > 5% annual decline in FEV1 with the lowest post-transplant FEV1/FVC < 0.8 and an appropriate CT scan or lung biopsy, see Appendix A for details) D. Subject may have previously any received immunosuppressive therapies for cGVHD. Continuing treatment with steroids and any one or none of the following is allowed: cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, or extracorporeal photopheresis. E. Subject has been on a fixed dose of steroids or a fixed dose of steroids and one other immunosuppressant (cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, or extracorporeal photopheresis) for >= 30 days before starting imatinib. F. Subject has a life expectancy >= 6 months. G. Subject has the ability to understand and willingness to sign a written informed consent document. H. Subject has a Karnofsky performance status^3 50% (Appendix B). I. Subject is 18 years of age. J. If a female with reproductive potential (defined as having at least 1 menstrual period in the past 12 months), the subject must have a negative pregnancy test performed <= 7 days before starting study drug. K. If a female with reproductive potential, the subject agrees to use contraception for the duration of the trial. L. Subject has a total bilirubin < 1.5X ULN. M. Subject has an aspartate transaminase (AST), alanine aminotransferase (ALT), and alkaline phosphatase < 2.5X ULN. N. Subject has an absolute neutrophil count > 500/uL (growth factor supplementation is allowed). O. Subject has a hematocrit > 26% (transfusion support is allowed). P. Subject has a platelet count > 20,000/uL.

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Contact information

Primary Contact:

Joanne Otani 6507212372

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

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