Allogeneic Stem Cell Transplantation for Patients With Severe Aplastic Anemia
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ClinicalTrials.gov Identifier: NCT00578266 |
Recruitment Status
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Completed
First Posted
: December 21, 2007
Last Update Posted
: March 24, 2017
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Sponsor:
Mayo Clinic
Information provided by (Responsible Party):
Shakila Khan, Mayo Clinic
Tracking Information | ||||
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First Submitted Date ICMJE | December 17, 2007 | |||
First Posted Date ICMJE | December 21, 2007 | |||
Last Update Posted Date | March 24, 2017 | |||
Study Start Date ICMJE | February 2007 | |||
Actual Primary Completion Date | August 16, 2016 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
1. Engraftment at 6 months, 1 year and 2 years 2.Incidence of graft versus host disease (GVHD), as well as incidence of acute GVHD and chronic GVHD within 6 months and 2 years [ Time Frame: 2 years ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT00578266 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Patient survival probability at 100 days, 1 year and 2 years. [ Time Frame: 2 years ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Allogeneic Stem Cell Transplantation for Patients With Severe Aplastic Anemia | |||
Official Title ICMJE | Allogeneic Stem Cell Transplantation for Patients With Severe Aplastic Anemia, Using Matched Unrelated Donors and Mismatched Related Donors | |||
Brief Summary | For patients with severe aplastic anemia (SAA) who have failed to respond to immunosuppressive therapy and lack an HLA identical family member, our objectives are to make an initial assessment of the safety and efficacy of allogenic stem cell transplantation from either a matched unrelated donor or a mismatched reacted donor using the conditioning regimen of Cytoxan, reduced total body irradiation (TBI) and Campath IH. The principle measures of safety and efficacy will be :
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Detailed Description | The objective of this trial is to make an initial assessment for this new treatment regimen and to show it is equal or superior to the current standard practice. With this initial assessment be hope to gain information suggesting further study of this regimen or discontinuation of this regimen before exposing large numbers of patients to this new treatment option. We also will gain experience with this new regimen giving insights as to possible modifications in dosing and monitoring and selection of patients for future treatment in case of positive results. For this initial study we plan to enroll up to 24 patients. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Anemia, Aplastic | |||
Intervention ICMJE | Drug: Cyclophosphamide,Campath IH and TBI
DAY 5 TREATMENT
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Study Arms | No Arms
Intervention: Drug: Cyclophosphamide,Campath IH and TBI |
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Publications * | Not Provided | |||
* 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 | Completed | |||
Actual Enrollment ICMJE |
8 | |||
Original Estimated Enrollment ICMJE |
24 | |||
Actual Study Completion Date | August 16, 2016 | |||
Actual Primary Completion Date | August 16, 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | up to 60 Years (Child, Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00578266 | |||
Other Study ID Numbers ICMJE | 06-006216 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Shakila Khan, Mayo Clinic | |||
Study Sponsor ICMJE | Mayo Clinic | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Mayo Clinic | |||
Verification Date | March 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |