Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04869254
Status:
COMPLETED
Last Update Posted:
2021-05-03
First Post:
2021-04-28
Brief Title:
Lymphocyte Count ATG Dose and Incidence and Severity of GVHD in Pediatric Recipients of HSCT
Sponsor:
IRCCS Burlo Garofolo
Organization:
IRCCS Burlo Garofolo
Study Overview
Official Title:
Correlation Between the Pre-transplantation Lymphocyte Count Administered Dose of Thymoglobulin and Graft Versus Host Disease GVHD in Pediatric Recipients of Hematopoietic Stem Cells Transplantation a Retrospective Study
Status:
COMPLETED
Status Verified Date:
2021-04
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:
None
Brief Summary:
Despite increasing success rate in hematopoietic stem cell transplantation HSCT control of graft versus host disease GVHD remains a significative burden in mortality and morbidity A lot of strategies could lower the incidence and gravity of the disease and immunosuppressive treatment as GVHD prophylaxis still represent the main method
Although immunosuppressive treatment showed a good effect on GVHD mortality a lot of studies also highlight an increase of relapse and infection related mortality that jeopardize the effect on overall survival of HSCT recipient Using anti thymocyte globulin ATG as GVHD prophylaxis shares the same double-edge effect as other immunosuppressive treatment although is still unclear how manage dose and timing of the infusion to minimize promoting effect on infections and maximize protective effect on GVHD Biological effect of ATG lead to a dose- related delay in all class of T-cell reconstitution but our data are mostly from adult studies with high doses between 30 and 60 mgkg due to the more important burden of GVHD in HSCT adult population As for other treatment in HSCT conditioning we would like to study a personalized approach for ATG treatment some studies focus on tuning of ATG dose for kilos but previous evidence showed that the same dose could made too little or too much immunosuppressive effect for different patients even though same age and same stem cell source
Although immunosuppressive treatment showed a good effect on GVHD mortality a lot of studies also highlight an increase of relapse and infection related mortality that jeopardize the effect on overall survival of HSCT recipient Using anti thymocyte globulin ATG as GVHD prophylaxis shares the same double-edge effect as other immunosuppressive treatment although is still unclear how manage dose and timing of the infusion to minimize promoting effect on infections and maximize protective effect on GVHD Biological effect of ATG lead to a dose- related delay in all class of T-cell reconstitution but our data are mostly from adult studies with high doses between 30 and 60 mgkg due to the more important burden of GVHD in HSCT adult population As for other treatment in HSCT conditioning we would like to study a personalized approach for ATG treatment some studies focus on tuning of ATG dose for kilos but previous evidence showed that the same dose could made too little or too much immunosuppressive effect for different patients even though same age and same stem cell source
Detailed Description:
None
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