A Pilot Study of Imatinib Mesylate in Steroid Refractory Chronic Graft Versus Host Disease
This trial is active, not recruiting.
|Condition||graft vs host disease|
|Targets||BCR-ABL, KIT, PDGF|
|Start date||September 2008|
|End date||August 2009|
|Trial size||15 participants|
|Trial identifier||NCT00760981, BMT195, SU-07112008-1254|
To determine if subjects with steroid refractory cGVHD can tolerate imatinib mesylate and whether their cGVHD responds to imatinib mesylate.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
The frequency of adverse events graded according to the CTCAE will be the primary endpoint
time frame: Subjects will be monitored at 1, 4, 8, 16, and 24 weeks.
Male or female participants at least 18 years old.
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 ³ 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. Exclusion Criteria:A. Subject has received another investigational agent <= 30 days before starting the study drug. B. Subject has an on-going, intercurrent illness such as an infection not responsive to antibiotics, antiviral medicines, or antifungal medicines. C. Subject has progressive malignant disease. D. Subject has a secondary malignancy that has not been effectively treated within the past 5 years (except localized basal cell or squamous cell carcinoma). E. Subject has imatinib intolerance or allergy. F. Subject is breast-feeding. G. Subject is not willing to comply with treatment or response evaluation. H. Subject has received an allogeneic cell product (including DLI or hematopoietic cell boost) <= 100 days before starting study drug. I. The subject's steroid and/or immunosuppressant dose has changed <= 30 days before starting study drug.
|Official title||A Pilot Study of Imatinib Mesylate in Steroid Refractory Chronic Graft Versus Host Disease|
|Principal investigator||David Miklos|
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