T-Cell Depletion and Stem Cell Transplant for Immune Deficiencies and Histiocytic Disorders
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First Received Date ICMJE | September 12, 2005 | ||||
Last Updated Date | September 5, 2012 | ||||
Start Date ICMJE | September 2000 | ||||
Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Time to transplant engraftment [ Time Frame: Day 100 Post Transplant ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00176826 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | T-Cell Depletion and Stem Cell Transplant for Immune Deficiencies and Histiocytic Disorders | ||||
Official Title ICMJE | In-vivo T-cell Depletion and Hematopoietic Stem Cell Transplantation for Life-Threatening Immune Deficiencies and Histiocytic Disorders | ||||
Brief Summary | 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. |
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Detailed Description | 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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 Phase 3 |
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Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arm (s) | Experimental: Intent-To-Treat
Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
Interventions:
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE | 40 | ||||
Estimated Completion Date | September 2015 | ||||
Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | up to 55 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00176826 | ||||
Other Study ID Numbers ICMJE | UMN-MT2000-21, 0010M66781 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Angela Smith, MD, Assistant Professor, Masonic Cancer Center, University of Minnesota | ||||
Study Sponsor ICMJE | Masonic Cancer Center, University of Minnesota | ||||
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Investigators ICMJE |
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Information Provided By | Masonic Cancer Center, University of Minnesota | ||||
Verification Date | September 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |