Status:
RECRUITING
αβT Cell/CD19+ B Cell Depletion for Alternative Donor Allogeneic Hematopoietic Cell Transplantation (HSCT)
Lead Sponsor:
Nationwide Children's Hospital
Conditions:
Hematopoietic Stem Cell Transplantation
Hematologic Malignancy
Eligibility:
All Genders
Up to 30 years
Phase:
NA
Brief Summary
This is a study utilizing the Magnetic-activated cell sorting (CliniMACS®) Alpha-Beta T-cell (αβT)/Cluster of Differentiation 19 (CD19), also called B lymphocyte antigen CD19 depletion device for Chil...
Eligibility Criteria
Inclusion
- Age ≤ 30 years
- Patients who will benefit from an allogenic stem cell transplant to treat underlying primary hematological malignancy and lacks a suitably available matched sibling donor.
- Karnofsky Index or Lansky Performance Scale ≥ 60 % on pre-transplant evaluation.
- Karnofsky scores must be used for patients \> 16 years of age and Lansky scores for patients ≤ 16 years of age.
- Patient or legal guardian must give informed consent if patient is ≥ 18 years. Legal guardian must give informed consent (and patient must give assent if appropriate) if patient is \< 18 years.
- Adequate organ function (within 4 weeks of initiation of preparative regimen). For patients receiving Myeloablative conditioning (MAC) on this platform, they should meet organ function to tolerate MAC. Similar if patients are receiving Reduced intensity conditioning (RIC).
- High resolution human leukocyte antigen (HLA) available
Exclusion
- Patient does not have a suitable donor who is willing and able (meets donor criteria).
- Patient reports a history of allergic reactions to murine protein
- Pregnant or lactating females are ineligible as many of the medications used in this protocol could be harmful to unborn children and infants. Female patients of childbearing potential females ≥11 years of age or post- menarche and should have a negative pregnancy test
- Patients with HIV or uncontrolled fungal, bacterial or viral infections are excluded. 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. Viremia by Pluripotency Check (PCR) analysis is not considered an active infection but may require immediate viral prophylaxis. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal therapy and be asymptomatic -
- Patients receiving umbilical cord blood and matched sibling donor transplants
Key Trial Info
Start Date :
December 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06082947
Start Date
December 18 2023
End Date
December 1 2030
Last Update
April 2 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205