Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06265584
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-02-05
Brief Title:
Trial of 2 Step ATG for Prevention of Acute GVHD Post 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 Reduced Intensity Allogeneic Stem Cell Transplant
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
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 can prevent grade III-IV acute GVHD and chronic GVHD resulting in improvement of GVHDrelapse free survival at one year post transplant
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None