Sirolimus as Treatment of Steroid-Refractory or Steroid-Dependent Chronic Graft-Versus-Host Disease

Not Recruiting

Trial ID: NCT00388362

Purpose

To study the effectiveness of an immunosuppressive drug sirolimus, in the treatment of chronic graft versus host disease in combination with prednisone.

Official Title

A Phase II Trial of Sirolimus as Treatment of Steroid-Refractory or Steroid-Dependent Chronic Graft-Versus-Host Disease

Stanford Investigator(s)

Laura Johnston
Laura Johnston

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Robert Lowsky
Robert Lowsky

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Robert Negrin
Robert Negrin

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Sally Arai
Sally Arai

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Judith Shizuru
Judith Shizuru

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and of Pediatrics (Stem Cell Transplantation)

Eligibility


Inclusion Criteria:

   - 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

Exclusion Criteria:

   - 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

Intervention(s):

drug: Sirolimus

drug: Prednisone

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
BMT Referrals
6507230822

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