Stem Cell Transplant for Immunologic or Histiocytic Disorders

Status Completed

Clinical Trial 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).

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Chediak-Higashi Syndrome
Disease
Griscelli Syndrome
Hemophagocytic Lymphohistiocytosis
Histiocytosis
Histiocytosis, Langerhans-Cell
Immunologic Deficiency Syndromes
Langerhans-Cell Histiocytosis
Lymphohistiocytosis, Hemophagocytic
Lymphoproliferative Disorders
Syndrome
X-Linked Lymphoproliferative Disorders

Clinical Trial Details

NCT number	NCT00176865
Study type	Interventional
Source	Masonic Cancer Center, University of Minnesota
Contact
Status	Completed
Phase	Phase 2
Start date	August 2002
Completion date	August 2014

View Details

See also
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