Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06559345
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-04
Brief Title:
A Prospective Open-label Randomized Controlled Multicenter Clinical Study of Haplo-HSCT Using a TBI or TMLI Conditioning Regimen for Pediatric ALL
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Open-label Randomized Controlled Multicenter Clinical Study of Haploidentical Hematopoietic Stem Cell Transplantation Using a TBI or TMLI Conditioning Regimen for Pediatric Acute Lymphoblastic Leukemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to compare the effects of two different conditioning regimens on patients with acute lymphoblastic leukemia ALL undergoing haploidentical allogeneic hematopoietic stem cell transplantation haplo-HSCT Total Body Irradiation TBI and Total Marrow Central Nervous System and Lymphoid Irradiation TMLI Both regimens are supported and recommended by literature however there is no definitive evidence favoring one over the other We hypothesize that the TMLI regimen compared to the TBI regimen may more effectively eliminate leukemia cells in the bone marrow and lymphoid tissues thereby reducing the risk of relapse while also minimizing damage to normal tissues thus reducing conditioning-related toxicity and transplant-related mortality This study aims to provide evidence for the optimal conditioning regimen for haplo-HSCT in pediatric ALL patients with the goal of improving patient quality of life and survival outcomes
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None