Status:
UNKNOWN
Reduced Toxicity Fludarabine (Flu) + Cyclophosphamide (CPM) + Rabbit Antithymocyte Globulin (rATG) Conditioning Regimen for Unrelated Donor Transplantation in Severe Aplastic Anemia (SAA)
Lead Sponsor:
The Korean Society of Pediatric Hematology Oncology
Conditions:
Aplastic Anemia
Eligibility:
All Genders
1-21 years
Phase:
PHASE2
Brief Summary
Anti-thymocyte globulin (ATG) has been used in severe aplastic anemia as a part of the conditioning regimen. Among the many kinds of ATG preparations, thymoglobulin had been found to be more effective...
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% and ejection fraction \> 45%.
- Liver: total bilirubin \< 2 × upper limit of normal; ALT \< 3 × upper
- 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.
- Appropriate donor is available: Matched in 6/6 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.
- Manipulated bone marrow.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2012
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00882323
Start Date
November 1 2008
End Date
October 1 2012
Last Update
March 26 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Seoul National University Hospital
Seoul, South Korea, 110-744