Ignite Creation Date:
2024-05-06 @ 1:54 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04151706
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2019-11-01
Brief Title:
CD34 Selected Allogeneic HCT w Myeloablative Conditioning Plus CD8 Memory TCell Infusion in MDS AL and CML
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
CD34 Selected Allogeneic Hematopoietic Cell Transplantation With Myeloablative Conditioning and CD8 Memory T Cell Infusion For Patients With Myelodysplastic Syndrome Acute Leukemia and Chronic Myelogenous Leukemia
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Interim analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate combining stem cells from the patients matched sibling donor a standard CD34-selected transplant with a second infusion of white blood cells called CD8 memory T-cells from their sibling donor
Detailed Description:
Primary Objective To determine the rate of graft versus host disease GvHD free relapse free survival GRFS at one year following CD34 selected allogeneic hematopoietic cell transplantation using myeloablative conditioning combined with an infusion of phenotypic CD8 memory T cells from human leukocyte antigen HLA matched donors for patients with myelodysplastic syndrome MDS acute myeloid leukemia AML or acute lymphoblastic leukemia ALL and chronic myeloid leukemia CML
Secondary Objective To determine the rate of graft rejection acute and chronic GvHD non relapse mortality relapse overall survival and disease free survival
Secondary Objective To determine the rate of graft rejection acute and chronic GvHD non relapse mortality relapse overall survival and disease free survival
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BMT339 | OTHER | None | None |
| IRB-49023 | OTHER | None | None |
| P01CA049605 | NIH | Stanford IRB | httpsreporternihgovquickSearchP01CA049605 |