Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06525519
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Comparison of Different Dose of Anti-T Lymphocyte Globulin ATLG in Haploidentical HSCT for GVHD Prophylaxis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Dose Study of Anti-T Lymphocyte Globulin ATLG in GVHD Prophylaxis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 incidence of graft-versus-host disease GVHD in haploidentical hematopoietic stem cell transplant recipients who receive varying doses of anti-T lymphocyte globulin ATLG for GVHD prophylaxis Our primary objective is to determine the optimal dose of ATLG for preventing acute GVHD aGVHD Additionally we plan to evaluate the impact of different doses of ATLG on post-transplant viral infections and other clinical outcomes
Detailed Description:
Allogeneic hematopoietic stem cell transplantation allo-HSCT is the only therapeutic option for many hematological malignancies Haploidentical related donor transplantation is now considered an important allo-HSCT GVHD prevention has a crucial role in post-transplant outcomes by potentially interfering with the graft-versus-leukemia GVL effect and immune reconstitution In vivo T cell depletion TCD modalities including anti-T lymphocyte globulin ATLG-based protocols have been widely used worldwide for GVHD prophylaxis
Several European studies have shown that a dose of 30mgkg of ATLG can effectively prevent GVHD with acceptable safety But the most commonly reported dose among Chinese population is 20mgkg Additionally the main type of allo-HSCT in China is haploidentical transplantation The application experience of ATLG in Europe mainly focuses on sibling and unrelated donor transplants There is still a lack of sufficient exploration on the optimal dose of ATLG in GVHD prevention in haploidentical transplantation
In this prospective multiple-center randomized trial we aim to compare the effects of different doses of ATLG on GVHD prevention risk of viral infection and patient survival after haploidentical transplantation
Several European studies have shown that a dose of 30mgkg of ATLG can effectively prevent GVHD with acceptable safety But the most commonly reported dose among Chinese population is 20mgkg Additionally the main type of allo-HSCT in China is haploidentical transplantation The application experience of ATLG in Europe mainly focuses on sibling and unrelated donor transplants There is still a lack of sufficient exploration on the optimal dose of ATLG in GVHD prevention in haploidentical transplantation
In this prospective multiple-center randomized trial we aim to compare the effects of different doses of ATLG on GVHD prevention risk of viral infection and patient survival after haploidentical transplantation
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