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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 March 2013 |
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Main ID: |
NCT00578266 |
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Date of registration:
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17/12/2007 |
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Primary sponsor: |
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Public title:
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Allogeneic Stem Cell Transplantation for Patients With Severe Aplastic Anemia
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Scientific title:
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Allogeneic Stem Cell Transplantation for Patients With Severe Aplastic Anemia, Using Matched Unrelated Donors and Mismatched Related Donors |
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Date of first enrolment:
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February 2007 |
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Target sample size:
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24 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00578266 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Shakila Khan, MD |
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Address:
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Telephone:
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507-284-3442 |
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Email:
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Khan.shakila@mayo.edu |
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Affiliation:
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Name:
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Shakila P Khan, M.D |
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Address:
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Telephone:
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507-284-3442 |
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Email:
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Khan.shakila@mayo.edu |
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Affiliation:
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Name:
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Shakila P. Khan, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mayo Clinic |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of SAA based on bone marrow aspirate and biopsy results. Failure to respond
to immunosuppressive therapy. Lack of an HLA identical family member.
- A 6/6 or 5/6 HLA matched unrelated donor or a 5/6 matched related donor available
after high resolution typing.
Exclusion Criteria:
- Patients with Aplastic anemia and active infection must be treated to maximally
resolve this problem before beginning the conditioning regimen.
- HIV seropositive patients
- Patients who have clonal cytogenetic abnormalities or a myelodysplastic syndrome.
- Patient greater than 60 years of age.
- Women who are pregnant or nursing.
- Patients with active hepatitis
- Patients with severe cardiac dysfunction defined as shortening fraction <25%.
- Patients with severe renal dysfunction defined as creatinine clearance
<40ml/mim/1.73m2.
- Patient with severe pulmonary dysfunction with FEV1, FVC and DLCO 40% of predicted or
3 SD below normal.
Age minimum:
N/A
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anemia, Aplastic
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Intervention(s)
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Drug: Cyclophosphamide,Campath IH and TBI
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Patient survival probability at 100 days, 1 year and 2 years.
[Time Frame: 2 years]
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Secondary ID(s)
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06-006216
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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