Status:
COMPLETED
A Pilot Study of Imatinib Mesylate in Steroid Refractory Chronic Graft Versus Host Disease
Lead Sponsor:
David Miklos
Collaborating Sponsors:
Novartis
Conditions:
Graft vs Host Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To determine if subjects with steroid refractory cGVHD can tolerate imatinib mesylate and whether their cGVHD responds to imatinib mesylate.
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Chronic graft-vs-host disease (cGVHD) requiring systemic therapy occurring \> 100 days after hematopoietic cell transplant with either:
- 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.
- Progression of cGVHD signs and symptoms on steroid therapy equivalent to prednisone 0.5 mg/kg/d for at least 1 month.
- At least one of the following manifestations:
- Skin changes (rash, sclerosis, fasciitis, or ulceration).
- Abnormal eye wetness ≤ 5 mm as measured by Schirmer's test.
- Oral mucosal changes (erythema, lichenoid changes, ulcers, or mucoceles).
- Thrombocytopenia (platelets \< 50,000/uL).
- Abnormal liver function testing defined as alkaline phosphatase, AST, ALT, or total bilirubin \> upper limit of normal (ULN).
- 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).
- 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.
- Life expectancy ≥ 6 months.
- Ability to understand and willingness to sign a written informed consent document.
- Karnofsky performance status ≥ 3 50% (Appendix B).
- At least 18 years of age.
- If a female of reproductive potential (defined as having at least 1 menstrual period in the past 12 months), must have a negative pregnancy test performed ≤ 7 days before starting study drug.
- If a female of reproductive potential, agrees to use contraception for the duration of the trial.
- Total bilirubin \< 1.5X ULN.
- Aspartate transaminase (AST) \< 2.5 x ULN.
- Alanine aminotransferase (ALT) \< 2.5 x ULN.
- Alkaline phosphatase \< 2.5 x ULN.
- Absolute neutrophil count (ANC) \> 500/uL (growth factor supplementation is allowed).
- Hematocrit \> 26% (transfusion support is allowed).
- Platelet count \> 20,000/uL.
- EXCLUSION CRITERIA
- Received another investigational agent ≤ 30 days before starting the study drug.
- Ongoing intercurrent illness such as an infection not responsive to antibiotics, antiviral medicines, or antifungal medicines.
- Progressive malignant disease.
- Secondary malignancy that has not been effectively treated within the past 5 years (except localized basal cell or squamous cell carcinoma).
- Imatinib intolerance or allergy.
- Participant is breast-feeding.
- Not willing to comply with treatment or response evaluation.
- Received an allogeneic cell product \[including donor lymphocyte infusion (DLI) or hematopoietic cell boost\] ≤ 100 days before starting study drug.
- Steroid and/or immunosuppressant dose has changed ≤ 30 days before starting study drug.
Exclusion
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00760981
Start Date
September 1 2008
End Date
April 1 2012
Last Update
April 15 2020
Active Locations (2)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305
2
Fred Hutchinson Cancer Research Center (FHCRC)
Seattle, Washington, United States, 98109