Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04806347
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2021-03-02
Brief Title:
AlphaBeta T-cell Depleted Blood-forming Stem Cell Transplant from Related or Unrelated Donors for Blood Diseases in Children and Young Adults
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
TCRαβ and CD19 Depleted Hematopoietic Stem Cell Transplant from Closely Matched Unrelated Donors or Haploidentical Related Donors for Hematologic Diseases in Children and Young Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This single institution phase I clinical trial will determine the safety and feasibility of employing T-cell receptor TCR αβ and CD19 Cluster of Differentiation depleted hematopoietic stem cell transplantation HSCT using peripheral blood stem cells PBMC from closely matched unrelated donors or haploidentical donors to treat non-malignant hematologic diseases in children and young adults Allogeneic hematopoietic stem cell transplantation has become a curative option for children and adolescents with a variety of otherwise fatal conditions To reduce the incidence and severity of graft-versus-host disease GVHD associated with allogeneic hematopoietic stem cell transplantation donor grafts are depleted of T cells either using CD34 selection or CD3CD19 depletion of grafts However these selection processes also deplete the graft of protective cell subsets such as γδ T cells natural killerNK cells monocytes and dendritic cells which play important roles in the immune response to infectious agents Moreover the presence of NK cells and γδ T in donor grafts is associated with more rapid immune reconstitution after HSCT transplantation In order to retain these protective immune cell subsets this trial will use a novel highly selective graft engineering process using the Miltenyi CliniMACS system that selectively depletes αβ-T cells and B cells which are responsible for GVHD and Epstein Barr Virus EBV-related post-transplantation lymphoproliferative disorder respectively Prior to transplantation patients will be treated with a conditioning regimen specific for the original disorder The primary objective of this study is evaluation of the safety and feasibility of HSCT using TCRαβCD19 depleted hematopoietic stem cells to treat non-malignant hematologic diseases This will be assessed by evaluating the incidence of graft failure grade III-IV acute GVHD and chronic GVHD and TRM Secondary objectives include the evaluation of immune reconstitution and incidence of post-transplant infections adverse events serious adverse events overall and disease-free survival and the efficiency of graft processing by the CliniMACS System
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2021-02128 | REGISTRY | NCI CTRP | None |
| 2020-1251 | OTHER | None | None |
| A536755 | OTHER | None | None |
| Protocol Version 4 | OTHER | None | None |