Trial Search Results

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 currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: Novartis


  • Drug: Imatinib


Phase 1


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 >

   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

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

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

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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Joanne Otani
Not Recruiting