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:

David Miklos

Collaborator: Novartis

Intervention(s):

  • Drug: Imatinib

Phase:

Phase 1

Eligibility


INCLUSION CRITERIA

   - Chronic graft-vs-host disease (cGVHD) requiring systemic therapy occurring > 100 days
   after hematopoietic cell transplant 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.

   - At least one of the following manifestations:

      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 < 50,000/uL).

      5. Abnormal liver function testing defined as alkaline phosphatase, AST, ALT, or
      total bilirubin > upper limit of normal (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).

   - 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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Joanne Otani
6507212372
Not Recruiting