Status:
UNKNOWN
Study of Fludarabine + Cyclophosphamide + TBI Conditioning Regimen for Double Units Cord Blood Transplantation(CBT)in Severe Aplastic Anemia(SAA)
Lead Sponsor:
The Korean Society of Pediatric Hematology Oncology
Conditions:
Aplastic Anemia
Eligibility:
All Genders
1-21 years
Phase:
PHASE1
PHASE2
Brief Summary
Severe aplastic anemia is a fatal disease and patients without HLA matched siblings need alternative treatment option. Cord blood transplantation (CBT) has become an alternative treatment means in var...
Eligibility Criteria
Inclusion
- Diagnosis of severe aplastic anemia defined by any two or three peripheral blood criteria and either marrow criterion.
- Peripheral blood
- Neutrophils \< 0.5 x 109/l
- Platelets \< 20 x 109/l
- Corrected reticulocytes \< 1%
- Bone marrow
- Severe hypocellularity (\< 25%)
- Moderate hypocellularity (25-30%) with hematopoietic cells representing \< 30% of residual cells
- No prior hematopoietic stem cell transplantation.
- Age: no limits.
- Performance status: ECOG 0-2.
- Patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases.
- Heart: a shortening fraction \> 30%, ejection fraction \> 45%.
- Liver: total bilirubin \< 2 × upper limit of normal; ALT \< 3 × upper limit of normal.
- Kidney: creatinine \<2 × normal or a creatinine clearance (GFR) \> 60 ml/min/1.73m2.
- Patients must lack any active viral infections or active fungal infection.
- No appropriate donor
- Appropriate cord blood is available: matched at least in 4/6 of A, B, DR loci.
- Patients (or one of parents if patients age \< 19) should sign informed consent.
Exclusion
- Pregnant or nursing women.
- Malignant or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.
- Psychiatric disorder that would preclude compliance.
- Congenital aplastic anemia including Fanconi anemia.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2012
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00881933
Start Date
November 1 2008
End Date
September 1 2012
Last Update
March 26 2012
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 110-744