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Sponsored by: |
Mayo Clinic |
Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00578266 |
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 :
Condition | Intervention | Phase |
Anemia, Aplastic |
Drug: Cyclophospamide,Campath IH and TBI |
Phase II Phase III |
MedlinePlus related topics: | Anemia |
ChemIDplus related topics: | Mesna Cyclophosphamide Tacrolimus Alemtuzumab Campath Tacrolimus anhydrous |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Allogeneic Stem Cell Transplantation for Patients With Severe Aplastic Anemia, Using Matched Unrelated Donors and Mismatched Related Donors |
Estimated Enrollment: | 24 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | February 2012 |
Arms | Assigned Interventions |
No Arms: No Intervention |
Drug: Cyclophospamide,Campath IH and TBI
DAY 5 TREATMENT
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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.
Ages Eligible for Study: | up to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Shakila P Khan, M.D | 507-284-3442 | Khan.shakila@mayo.edu |
United States, Minnesota | |||||
Mayo Clinic | Recruiting | ||||
Rochester, Minnesota, United States, 55905 | |||||
Principal Investigator: Shakila P Khan, M.D |
Mayo Clinic |
Principal Investigator: | Shakila P. Khan, M.D. | Mayo Clinic |
Responsible Party: | Mayo Clinic ( Shakila Khan M.D. ) |
Study ID Numbers: | 06-006216 |
First Received: | December 17, 2007 |
Last Updated: | December 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00578266 |
Health Authority: | United States: Institutional Review Board |
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