Allogeneic Hematopoietic Stem Cell Transplant for Patients With Immunologic or Histiocytic Disorders Using a Non-Myeloablative Preparative Regimen to Achieve Stable Mixed Chimerism
Prior to transplantation, subjects will receive Melphalan, Fludarabine and Anti-Thymocyte
Globulin (ATG) or Campath. These three drugs are being given to subjects to help the new
stem cells take and grow. On the day of transplantation, subjects will receive stem cells
transfused via intravenous (IV) catheter.
After stem cell transplantation, subjects will be given Cyclosporin A (CsA) and
mycophenolate mofetil (MMF) to reduce the risk of graft-versus-host disease, the
complication that occurs when the donor's stem cells react against the patient.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To demonstrate the safety and the ability to establish stable mixed chimerism (>10% donor cells at day 100) using a nonmyeloablative preparative regimen in a phase 2 pilot trial
Angela Smith, MD
Masonic Cancer Center, University of Minnesota
United States: Institutional Review Board
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