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 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT06393660
Eligibility Criteria:
Recipient Inclusion Criteria:
* Age less than 22 years of age
* No available genotypically matched related donor (sibling)
* Availability of a suitable donor and graft source
* Haploidentical related mobilized peripheral blood cells
* 9/10 or 10/10 allele matched (HLA-A, -B, -C, -DRB1, -DQB1) volunteer unrelated donor mobilized peripheral blood cells
Donor Inclusion Criteria:
* Matching as described in the Recipient and Donor Suitability Criteria
* Size and vascular access appropriate by center standard for peripheral blood stem cell (PBSC) collection. Donors with inadequate peripheral access will require placement of an apheresis catheter for collection.
* Must meet appropriate screening/eligibility requirements:
* Haploidentical matched family members: screened by center health screens and found to be eligible.
* Unrelated donors: meet suitability criteria to donate PBSC
* HIV negative
* Not pregnant or lactating
* Recipient must not have high-level donor specific anti-HLA antibodies according to institutional practices.
* Must agree to donate PBSC
* Must give informed consent
Recipient Suitability:
\- Adequate organ functioning as demonstrated by:
* MUGA ≥ 50% or ECHO \>30%
* 24-hour Creatinine Clearance or Glofil ≥ 50 ml/min or Serum Creatinine ≤2 times the upper limit of normal
* DLCO \> 65% of predicted value. FEV1 \>65% of predicted
* AST / ALT ≤ 2.5 and/or Bilirubin ≤ 1.5 times the upper limit of normal
* Pregnancy test negative
* HIV 1 / 2 (HIV screen) negative with a negative qualitative HIV PCR.
* HTLV I negative
* RPR or VDRL negative
* RVP (Respiratory Viral PCR) with a negative result
* Positive hepatitis testing does not make the patient ineligible. Hepatitis results will be evaluated on a case-by-case basis by the transplant physician to determine donor suitability/eligibility.
Donor Suitability:
\- Allowed Donor Sources
* Fully matched sibling donors are not allowed.
* Unrelated donors. HLA typing of at least 10 alleles is required. Donor must be matched at 9/10 or 10/10 alleles (HLA-A, -B, -C, -DRB1, -DQB1). Haploidentical matched family members. Minimum match level full haploidentical (at least 5/10; HLA-A, -B, -C, -DRB1, -DQB1 alleles), but use of haploidentical donors with extra matches (e.g., 6, 7, or 8/10) encouraged.
* Cord blood is not allowed as a stem cell source on this IDE.
Recipient and Donor Exclusion Criteria:
* Pregnant or lactating females are ineligible as the risk to unborn children and infants is unknown
* Presence of life-threatening, uncontrolled opportunistic infection (fungal, bacterial, or viral infections). Patients with history of fungal disease during induction therapy may proceed if they have a significant response to antifungal therapy with no or minimal evidence of disease remaining by CT evaluation.
* HIV or HTLV I/II infection
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
21 Years
Study:
NCT06393660
Study Brief:
Protocol Section:
NCT06393660