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Sponsors and Collaborators: |
Stanford University Novartis |
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Information provided by: | Stanford University |
ClinicalTrials.gov Identifier: | NCT00760981 |
To determine if subjects with steroid refractory cGVHD can tolerate imatinib mesylate and whether their cGVHD responds to imatinib mesylate.
Condition | Intervention | Phase |
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Graft vs Host Disease |
Drug: Imatinib |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Pilot Study of Imatinib Mesylate in Steroid Refractory Chronic Graft Versus Host Disease |
Estimated Enrollment: | 15 |
Study Start Date: | September 2008 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
C. Subject has at least one of the following manifestations with which to follow progression of disease or response to imatinib:
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.
United States, California | |
Stanford University School of Medicine | Recruiting |
Stanford, California, United States, 94305 | |
Contact: Joanne Fehling, RN, MSN 650-721-2372 jfehling@stanford.edu | |
Contact: Cancer Clinical Trials Office (650) 498-7061 | |
Principal Investigator: David Miklos | |
Sub-Investigator: Wen-Kai Weng | |
Sub-Investigator: Judith Anne Shizuru | |
Sub-Investigator: William Hewitt Robinson | |
Sub-Investigator: Robert S Negrin | |
Sub-Investigator: Robert Lowsky | |
Sub-Investigator: Ginna Laport | |
Sub-Investigator: Laura Johnston | |
Sub-Investigator: David Franklin Fiorentino | |
Sub-Investigator: Howard Y. Chang | |
Sub-Investigator: Jonathan Eliot Benjamin | |
Sub-Investigator: Sally Arai |
Principal Investigator: | David Miklos | Stanford University |
Study ID Numbers: | SU-07112008-1254, BMT195, NCT00760981 |
Study First Received: | September 25, 2008 |
Last Updated: | December 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00760981 |
Health Authority: | United States: Institutional Review Board |
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