Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-25 @ 2:42 AM
NCT ID:
NCT00881933
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
21 Years
Study:
NCT00881933
Study Brief:
Protocol Section:
NCT00881933