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:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2025-12-24 @ 3:49 PM
NCT ID:
NCT02828592
Eligibility Criteria:
Inclusion Criteria:
* Availability of 3/6 - 5/6 matched (HLA-A, B, DR) related donor who must have negative HLA cross-match in the host vs. graft direction
* Age \<= 65 years for previously treated and \<= 75 years for previously treated patients
* KPS \>= 70%
* Aplastic Anemia that meets the following criteria:
Peripheral Blood (must fulfill 2 of 3):
* \<500 PMN/mm3
* \<20,000 platelets
* absolute reticulocyte count \<40,000/microL
Bone Marrow (must be either):
* markedly hypocellular (\<25% of normal cellularity)
* moderately hypocellular with 70% non-myeloid precursors and patient meets peripheral blood criteria above
Exclusion Criteria:
* poor cardiac function (LVEF \<40%)
* poor pulmonary function (FEV1 \& FVC \<50% predicted)
* poor liver function (bili \>= 2mg/dL)
* poor renal function (creatinine \>= 2.0mg/dL or creatinine clearance \<40mL/min)
* prior allogeneic transplant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
75 Years
Study:
NCT02828592
Study Brief:
Protocol Section:
NCT02828592