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 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT02510404
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of primary immunodeficiency with established plan to undergo myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant for treatment thereof or diagnosis of a form of primary immunodeficiency for which hematopoietic stem cell transplantation is not indicated.
2. Active infection with EBV, CMV, and/or Adenovirus, unable to be successfully controlled with standard therapy.
3. Steroids less than 0.5 mg/kg/day prednisone
4. Karnofsky/Lansky score of ≥ 50
5. ANC greater than 500/µL.
6. Bilirubin \<2x, AST \<3x, Serum creatinine \<2x upper limit of normal, Hgb \>8.0
7. Pulse oximetry of \> 90% on room air
8. Negative pregnancy test (if female of childbearing potential)
9. Patient or parent/guardian capable of providing informed consent.
Exclusion Criteria:
1. Patients with other uncontrolled infections (see 2.3.2 for definitions)
2. Patients who received ATG, Campath, or other T cell immunosuppressive monoclonal antibodies in the last 28 days
3. Received donor lymphocyte infusion in last 28 days
4. Diagnosis of Omenn's syndrome or MHC class I deficiency
5. Active and uncontrolled malignancy
6. Pregnant or lactating
7. Unable to wean steroids to ≤0.5 mg/kg/day prednisone.
8. Patients with Grade 3 hyperbilirubinemia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Weeks
Maximum Age:
45 Years
Study:
NCT02510404
Study Brief:
Protocol Section:
NCT02510404