Neoplasms

Blood and Lymph Conditions

All Conditions

Hematologic Neoplasms

Hematologic Diseases

The infusion of the final TCRαβ/CD19 depleted product will be given through the recipient's central venous catheter and will be administered fresh, without cryopreservation whenever possible. If the product must be cryopreserved and then thawed, this will be done according to institutional standards.

Miltenyi Biotec's CliniMACS Plus Instrument is to be used to TCRαβ CD19 deplete products utilized in this protocol. The CliniMACS Plus is an automated cell separation platform which is functionally closed, maintaining a sterile system for cell depletion and enrichment utilizing a magnetic separation column. Reagents and supplies are to be used for research only but are manufactured and tested under a quality system certified to ISO 13485. Should CD34 selection be required to augment stem cell dose, Miltenyi Biotec's CliniMACS® Plus CD34 Reagent System is FDA approved as a Humanitarian Use Device (HUD). The approved indication was the treatment of patients with acute myeloid leukemia (AML) undergoing myeloablative transplant from matched related allogeneic donors. The CliniMACS® Plus reagent system was approved to obtain an enriched CD34+ cell population for hematopoietic reconstitution without the need for GVHD prophylaxis.

CliniMACS Plus Instrument

Kayla Pacheco

Alisa Lee Sherick

Alisa B Lee Sherick

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.

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 malignant or non-malignant hematologic disease who are eligable for allogeneic HCT, but lack a HLA-matched sibling donor.

Eligible Patients with a hematologic disease who could benefit from HCT with an eligible mismatched related or unrelated donor per donor selection criteria. Patient/recipient admitted of HCT/start of preparative regimen and stem cell infusion

TCR Alpha/Beta and CD19-deplete Haplo-HSCT

TCR Alpha/Beta and CD19-depleted Allogeneic Hematopoietic Cell Transplant for Malignant and Non-Malignant Disease

Grade to be determined using Acute GVHD Staging Scale

Defined as the lack of donor-derived neutrophil engraftment

Interval from transplant to relapse/recurrence of disease

Defined as death due to regimen-related toxicity or GVD.

Defined as the minimum time interval from transplant to relapse/recurrence of disease, death or last follow-up.

Incidence of absolute CD4+ T-cell count \>400 cells at 1 year post-HCT

Incidence of bacterial, fungal, and viral infections at day +100

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
TCR Alpha/Beta and CD19-deplete Haplo-HSCT	NCT05288595	Pediatric Patie... Hematologic Mal... Other Hematolog...	CliniMACS Plus ...	31 Days - 30 Years	University of Colorado, Denver
TCR Alpha/Beta and CD19-deplete Haplo-HSCT	NCT05288595	Pediatric Patie... Hematologic Mal... Other Hematolog...	CliniMACS Plus ...	31 Days - 30 Years	University of Colorado, Denver

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