Status:
WITHDRAWN
TCRαβ/CD19 Depletion of Stem Cell Grafts for Transplant
Lead Sponsor:
Neena Kapoor, M.D.
Conditions:
Graft Vs Host Disease
Graft-versus-host-disease
Eligibility:
All Genders
Up to 21 years
Phase:
NA
Brief Summary
The CliniMACS® device is FDA-approved only for one indication (CD34+ selection). Additional use of this device outside of this indication requires the use of feasibility studies. Children, adolescent...
Detailed Description
Hematopoietic stem cell transplantation (HSCT) is recognized as an effective cure for a wide range of diagnoses including hematologic malignancies, bone marrow failure syndromes, red blood cell disord...
Eligibility Criteria
Inclusion
- Written informed consent (and written assent, if applicable) obtained prior to enrollment.
- Age \< 21.
- Lansky Play-Performance Scale or Karnofsky Index score ≥ 60%.
- Adequate organ function (within 4 weeks of initiation of preparative regimen) as evaluated per institutional guidelines. Adequate major organ system function as demonstrated by:
- Renal: Creatinine clearance or GFR of ≥ 60mL/min/1.73m2.
- Hepatic: total bilirubin \< 2 mg/dL (unless due to Gilbert syndrome) and ALT/AST ≤ 2.5 times the upper limit of normal.
- Cardiac: LVEF at rest ≥ 50% or SF ≥ 27% (by MUGA or ECHO).
- Pulmonary: DLCO, FEV1, and FVC ≥ 50% of predicted corrected for hemoglobin. For patients \< 7 years of age or those unable to perform PFTs: O2 Sat ˃ 92% on room air by pulse oximetry and on no supplemental O2 at rest.
- Available donor (matched/mismatched unrelated, mismatched related, related haploidentical) who is healthy and willing to donate peripheral blood stem cells.
- Patients that have been diagnosed with graft rejection/failure or relapse may be eligible to receive a second transplant pending patient status.
Exclusion
- Patients with HIV or uncontrolled fungal, bacterial, or viral infections.
- Patients with active CNS leukemia or any other active site of extramedullary disease at the time of enrollment.
- Recipient with HLA antibody against donor.
- Patients that are pregnant, breastfeeding or unwilling to practice birth control during participation of the study.
- Any condition that, in the opinion of the Sponsor-Investigator, would compromise the safety of the participant, prevent study participation, or interfere with the evaluation of study endpoints.
Key Trial Info
Start Date :
May 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2035
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05968170
Start Date
May 27 2025
End Date
July 1 2035
Last Update
July 14 2025
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