Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06461091
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-05-13
Brief Title:
the Efficacy and Safety of Total Myeloid Irradiation TMI in the Treatment of Adult Acute Lymphoblastic Leukemia
Sponsor:
Institute of Hematology Blood Diseases Hospital China
Organization:
Institute of Hematology Blood Diseases Hospital China
Study Overview
Official Title:
A Prospective Single-arm Exploratory Clinical Study of the Efficacy and Safety of Total Myeloid Irradiation TMI in the Treatment of Adult Acute Lymphoblastic Leukemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
TMI
Brief Summary:
Observation of event-free survival engraftment rate overall survival OS and safety data in patients aged 16 years with acute lymphoblastic leukemia ALL receiving a conditioning regimen including total marrow irradiation TMI followed by allogeneic hematopoietic stem cell transplantation Aim to further enhance transplant outcomes in ALL patients based on the existing basis
Detailed Description:
Observation of event-free survival engraftment rate overall survival OS and safety data in patients aged 16 years with acute lymphoblastic leukemia ALL receiving a conditioning regimen including total marrow irradiation TMI followed by allogeneic hematopoietic stem cell transplantation Aim to further enhance transplant outcomes in ALL patients based on the existing basisExploratory Endpoint Event-free survival at 1 year post allogeneic hematopoietic stem cell transplantation EFSSecondary Exploratory Endpoints 1 Rate of granulocyte and platelet hematopoietic recovery 2 Incidence of toxicity related to the conditioning regimen
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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