Stem Cell Transplant for Immunologic or Histiocytic Disorders
Summary
This study tests the clinical outcomes of a preparative regimen of fludarabine (FLU), anti-thymocyte globulin (ATG)/or Campath, and melphalan; followed by hematopoietic stem cell transplant, and a post transplant regimen of Cyclosporin A (CsA) in patients with immunologic or histiocytic disorders. The researchers hypothesize that this regimen will have a positive effect on post transplant engraftment and the incidence of graft-versus-host-disease (GVHD). Patients will be randomized biologically into one of 3 arms based upon donor availability: (a) human leukocyte antigen (HLA) genotypic matched sibling donor, (b) HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor, (c) two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).
Timeline
- Start
- 2002-08
- Primary completion
- 2012-08
- Completion
- 2014-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | 30 mg/kg | Intravenous |
| Comparator | Alemtuzumab | Monoclonal antibody | 0.2 mg/kg | Intravenous |
| Comparator | Cyclosporine | Peptide | 2.5 mg/kg | Intravenous |
| Comparator | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |
| Comparator | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 500 mg/kg | Intravenous |
| Comparator | Melphalan | Small molecule | 140 mg/m2 | Intravenous |
| Comparator | Mycophenolate Mofetil | Small molecule | 15 mg/kg | Intravenous |