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The hypothesis is to determine if a preparative regimen of busulfan, cyclophosphamide, and antithymocyte globulin (ATG) plus allogeneic stem cell transplantation will be effective in the treatment of immune deficiencies and histiocytic disorders.
U.S. FDA Resources
Further study details as provided by University of Minnesota: Primary Outcome Measures:
Secondary Outcome Measures:
Intervention Details:
Detailed Description:
Transplantation of hematopoietic stem cells (bone marrow, cord blood, peripheral blood stem cells) following myeloablative conditioning regimen Procedure: In-vivo T-cell Depletion
Rabbit ATG (Thymoglobulin) is use for in-vivo T cell depletion. Drug: busulfan, cyclophosphamide, and antithymocyte globulin (ATG)
Busulfan iv for 4 days followed by cyclophosphamide iv for 4 days. rabbit ATG is given for 4 doses pre-transplant. Subjects will begin chemotherapy as a preparative regimen, which is intended to completely eliminate their defective immune system and bone marrow. The preparative regimen consists of the chemotherapy drugs (busulfan, cyclophosphamide, and antithymocyte globulin (ATG)). Transplantation: subjects will then have a source of blood stem cells (bone marrow) from their donor administered into their catheter. Medication will be given to help prevent Graft-Versus Host Disease (GVHD). The ATG will help to deplete the donor stem cells of the type of cells that can cause GVHD and will also help to promote engraftment of the new stem cells. Recovery Phase: The second phase of treatment consists of a period after transplantation during which we wait for the return of bone marrow function. This usually takes two to four weeks. Subjects will be given a blood cell growth factor, G-CSF, to help speed recovery of the white blood cells and potentially decrease the risk of infection and decrease the time until the bone marrow recovers. Eligibility
Criteria Inclusion Criteria:
Exclusion Criteria:
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00176826 Contacts
Locations
Sponsors and Collaborators
Investigators
More Information
Keywords provided by University of Minnesota:
Study placed in the following topic categories:
Additional relevant MeSH terms:
Source: National Library of Medicine (NLM) July 10, 2008 |
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