Ignite Creation Date:
2024-05-06 @ 7:39 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06082947
Status:
RECRUITING
Last Update Posted:
2024-02-16
First Post:
2023-10-03
Brief Title:
αβT CellCD19 B Cell Depletion for Alternative Donor Allogeneic Hematopoietic Cell Transplantation HSCT
Sponsor:
Nationwide Childrens Hospital
Organization:
Nationwide Childrens Hospital
Study Overview
Official Title:
αβT CellCD19 B Cell Depletion for Alternative Donor Allogeneic Hematopoietic Cell Transplantation HSCT for Children and Young Adults With Hematologic Malignancies
Status:
RECRUITING
Status Verified Date:
2024-02
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:
TB19DHCT
Brief Summary:
This is a study utilizing the Magnetic-activated cell sorting CliniMACS Alpha-Beta T-cell αβTCluster of Differentiation 19 CD19 also called B lymphocyte antigen CD19 depletion device for Children and Young Adults with Hematologic Malignancies undergoing alternative Donor Allogeneic Hematopoietic Cell Transplantation HSCT Patients will receive an allogenic HSCT from a matched unrelated donor MUD mismatch unrelated donor MMUD or a mismatched related haploidentical donor Patients will receive a granulocyte-colony stimulating factor G-CSF Plerixafor donor mobilized peripheral stem cell donor transplant following CliniMACS αβT cellCD19B cell depletion Cluster of Differentiation 34 CD34 and αβT cell content of the graft is determined based on the transplant indication
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