Status:
COMPLETED
Partially Matched Stem Cell Transplantation for Patients With Refractory Severe Aplastic Anemia or Refractory Cytopenias
Lead Sponsor:
St. Jude Children's Research Hospital
Conditions:
Anemia, Aplastic
Amegakaryocytic Thrombocytopenia
Eligibility:
All Genders
Up to 21 years
Phase:
NA
Brief Summary
Due to an overall and disease free survival of 85% to 100%, allogeneic blood or bone marrow stem cell transplantation using an HLA matched sibling donor is the therapy of choice for patients with seve...
Detailed Description
Secondary objectives for this protocol include the following: * To observe the degree of hematopoietic chimerism in T-cells during the first year posttransplant. * To observe the relative proportions...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- One of the following diagnoses:
- Refractory severe aplastic anemia
- Refractory Kostmann syndrome
- Refractory Diamond-Blackfan anemia
- Refractory amegakaryocytic thrombocytopenia
- Absence of a suitable HLA-matched sibling donor and absence of a 10/10 allele matched unrelated donor.
- Life expectancy of greater than six weeks as per the judgment of the principal investigator.
- Karnofsky or Lansky Performance Status score of greater than or equal to 70%.
- Creatinine clearance is greater than or equal to 40 cc/min/1.73 m2.
- FVC greater than or equal to 40% of predicted or pulse oximetry greater than or equal to 92% on room air.
- Does not have a known allergy to murine products.
- Exclusion criteria:
- Ejection fraction or shortening fraction below the lower limit of normal for age.
- Lactating (female patient).
- Pregnant or lactating
- Diagnosis of Fanconi Anemia.
- Positive HLA crossmatch with donor
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00244010
Start Date
October 1 2005
End Date
February 1 2009
Last Update
May 30 2017
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105