Sirolimus as Treatment of Steroid-Refractory or Steroid-Dependent Chronic Graft-Versus-Host Disease
Trial ID or NCT#
To study the effectiveness of an immunosuppressive drug sirolimus, in the treatment of chronic graft versus host disease in combination with prednisone.
A Phase II Trial of Sirolimus as Treatment of Steroid-Refractory or Steroid-Dependent Chronic Graft-Versus-Host Disease
- - Age ≥ 13 years - Weight ≥ 40 kg. - Biopsy or clinical presentation diagnostic of chronic GVHD >100 days following allogeneic bone marrow/peripheral blood/umbilical cord blood transplantation that has failed prior corticosteroid therapy or corticosteroid taper. In the event that histological confirmation poses undue risk, clinical evaluation is sufficient. - Women of child-bearing potential must have a negative pregnancy test before sirolimus administration and agree to use a medically acceptable contraceptive throughout the treatment period until 3 months after discontinuation of sirolimus. - Any woman becoming pregnant during the treatment period must discontinue the use of sirolimus. - Absolute neutrophil count (ANC) > 1000/mm³, unless receiving G-CSF to maintain neutrophil count > 500/mm³. - At the time of initiating sirolimus the cyclosporine trough level is recommended to be < 100 mg/dl and FK506 level is recommended to be < 5 mg/dl. FK506 or cyclosporine is to be discontinued soon after initiation of sirolimus. - Karnofsky performance score ≥ 50 during pre-study screening. - Written, signed, and dated informed consent
- - Uncontrolled systemic infection - Unstable disease states (i.e., hepatic failure, ventilatory-dependent respiratory failure, etc.) - Serum creatinine ≥ 3.0 mg/dL - Platelet count ≤ 50,000/mm³ - History of Post-transplant microangiopathic hemolytic anemia - Uncontrolled hyperlipidemia - Use of any investigational drug within 4 weeks of entry into the study - Use of methotrexate or antibody therapies within 24 hours of sirolimus administration - Inability to tolerate oral therapy for any reason - Evidence of infiltrate, cavitation, or consolidation on chest x-ray during pre-study screening - Known hypersensitivity to macrolide antibiotics
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