Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06315309
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-03-11
Brief Title:
Trial of 2 Step ATG for Acute GVHD Prevention Post Myeloablative Allogeneic Stem Cell Transplant
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Phase II Clinical Trial of 2 Step ATG Combined With Tacrolimus and Mini Methotrexate for Prevention of Acute GVHD Post Myeloablative Allogeneic Stem Cell Transplant
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
The purpose of this study is to test whether the combination of the drugs called tacrolimus Tac methotrexate MTX and new dosing strategy of another drug called rabbit Anti-thymocyte Globulin ATG will help prevent the development andor improve severity of acute andor chronic GVHD
Detailed Description:
The goal is to study the effectiveness and drug levels of new dosing strategy of ATG GVHD preventing medicine in preventing graft versus host disease post allogeneic stem cell transplantation
In an effort to reduce graft versus host disease GVHD and enhance graft versus leukemia GVL effect post allogenic hematopoietic stem cell transplantation AHSCT recent research has focused on host immune cell depletion Frame shifting anti-thymocyte globulin ATG backwards to earlier days before days 0 can result in deeper host and less graft T-cell depletion leading to better immune reconstitution Preliminary data where 80 of the ATG dose is given on days -6-5-4 and 20 given on day -1 showed effective prevention of severe acute GVHD chronic GVHD and favorable early immune reconstitution We hypothesize that our 2 step ATG dosing platform when combined with standard tacrolimus and mini methotrexate in a myeloablative setting can prevent grade III-IV acute GVHD and chronic GVHD resulting in improvement of GVHDrelapse free survival at one year post transplant
This study aims to
1 Confirm the effectiveness of ATG based GVHD prevention regimen based on the encouraging clinical outcomes observed above
2 Examine ATG blood levels pre and post-transplant to evaluate any possible correlation between ATG levels and its ability to protect from GVHD
3 Examine post-transplant immune cell recovery as part of routine post-transplant immune monitoring at UABMC
In an effort to reduce graft versus host disease GVHD and enhance graft versus leukemia GVL effect post allogenic hematopoietic stem cell transplantation AHSCT recent research has focused on host immune cell depletion Frame shifting anti-thymocyte globulin ATG backwards to earlier days before days 0 can result in deeper host and less graft T-cell depletion leading to better immune reconstitution Preliminary data where 80 of the ATG dose is given on days -6-5-4 and 20 given on day -1 showed effective prevention of severe acute GVHD chronic GVHD and favorable early immune reconstitution We hypothesize that our 2 step ATG dosing platform when combined with standard tacrolimus and mini methotrexate in a myeloablative setting can prevent grade III-IV acute GVHD and chronic GVHD resulting in improvement of GVHDrelapse free survival at one year post transplant
This study aims to
1 Confirm the effectiveness of ATG based GVHD prevention regimen based on the encouraging clinical outcomes observed above
2 Examine ATG blood levels pre and post-transplant to evaluate any possible correlation between ATG levels and its ability to protect from GVHD
3 Examine post-transplant immune cell recovery as part of routine post-transplant immune monitoring at UABMC
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