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 @ 3:30 PM
Ignite Modification Date:
2025-12-24 @ 3:30 PM
NCT ID:
NCT01652092
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of immunodeficiency or histiocytic disorder including the following:
* Severe combined immunodeficiency (SCID - all variants)
* Second bone marrow transplant (BMT) for SCID (after graft rejection)
* Omenn's Syndrome
* Reticular dysgenesis
* Wiskott-Aldrich syndrome
* Major histocompatibility complex (MHC) Class II deficiency (bare lymphocyte syndrome)
* Hyper IgM Syndrome (CD40 Ligand Deficiency)
* Common variable immunodeficiency (CVID) with severe phenotype
* Chronic Granulomatous Disease (CGD)
* Other severe Combined Immune Deficiencies (CID)
* Hemophagocytic Lymphohistiocytosis (HLH)
* X-linked Lymphoproliferative Disease (XLP)
* Chediak-Higashi Syndrome (CHS)
* Griscelli Syndrome
* Langerhans Cell Histiocytosis (LCH)
* Acceptable stem cell sources include:
* HLA identical or 1 antigen matched sibling donor eligible to donate bone marrow
* HLA identical or up to a 1 antigen mismatched unrelated BM donor
* Sibling donor cord blood with acceptable HLA match and cell dose as per current institutional standards
* Single unrelated umbilical cord blood unit with 0-2 antigen mismatch and minimum cell dose of \>5 x 10\^7 nucleated cells/kg as per current institutional guidelines
* Double unrelated umbilical cord blood units that are:
* up to 2 antigen mismatched to the patient
* up to 2 antigen mismatched to each other
* minimum cell dose of at least one single unit must be ≥ 3.5 x 10\^7 nucleated cells/kg
* combined dose of both units must provide a total cell dose of ≥ 5 x 10\^7 nucleated cells/kg
* Age: 0 to 50 years
* Adequate organ function and performance status.
Exclusion Criteria
* pregnant or breastfeeding
* active, uncontrolled infection and/or HIV positive
* acute hepatitis or evidence of moderate or severe portal fibrosis or cirrhosis on biopsy
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
50 Years
Study:
NCT01652092
Study Brief:
Protocol Section:
NCT01652092