Status:
WITHDRAWN
TCR Alpha/Beta and CD19-deplete Haplo-HSCT
Lead Sponsor:
University of Colorado, Denver
Conditions:
Pediatric Patients
Hematologic Malignancy
Eligibility:
All Genders
31-30 years
Phase:
PHASE2
Brief Summary
This is an open label, interventional, non-randomized, phase II trial of TCR alpha/beta and CD19-depeleted allogeneic HCT in pediatric patients with hematologic disease.
Detailed Description
This is a single-site, open label, interventional, non-randomized, phase II trial of TCRαβ/CD19 deplete allogeneic HCT as donor source and sole GVHD prophylaxis in pediatric patients with either malig...
Eligibility Criteria
Inclusion
- Age 31 days to \<30 years
- Have a malignant or non-malignant hematologic disease, defined as disease resulting from abnormal function of a cell of the hematopoietic stem cell lineage, that could benefit from an allogeneic HCT. Examples include acute and chronic leukemias, myelodysplastic syndrome, lymphoma, severe acquired and congenital cytopenias/marrow failure, white blood cell abnormalities, red blood cell abnormalities, and platelet abnormalities.
- Clinical remission for patients with acute leukemia (MDS/AML excluded) or lymphoma
- Lack a healthy and willing HLA-identical related donor, with the exception of patients with FA who will be eligible with a willing HLA-identical related donor given the standard use of T-cell depletion in matched sibling donor HCT in FA
- Have a related or an unrelated donor who meets the donor selection criteria, is healthy, willing, and able to receive GCSF with or without Plerixafor, and undergo apheresis through placement of catheters in the antecubital veins or a temporary central venous catheter
- Able to give informed consent if ≥ 18 years, or with legal guardian capable of giving informed consent if \< 18 years
- Provision of signed and dated informed consent form
Exclusion
- Uncontrolled, active infection at time of HCT
- HIV positivity
- Cardiac ejection fraction \<45%
- Creatinine clearance \<60 mL/min/1.72 mL
- Pulmonary diffusion capacity (adjusted for hemoglobin), FEV1, or FVC \<60% of predicted or an O2 saturation \<94% on room air if unable to perform pulmonary function testing
- Serum ALT \>5x upper limit of normal or bilirubin \>2
- Performance score (Lansky or Karnofsky) \<50
- Pregnant or lactating females, as many medications necessary for a successful HCT are potentially harmful to unborn babies and infants.
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2028
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05288595
Start Date
December 1 2024
End Date
April 1 2028
Last Update
October 18 2024
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.