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Clinical Trial 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 and/or improve severity of acute and/or chronic GVHD.


Clinical Trial 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 GVHD/relapse 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 Design


Related Conditions & MeSH terms


NCT number NCT06315309
Study type Interventional
Source University of Alabama at Birmingham
Contact Zaid S Al Kadhimi, MD
Phone 205-975-1269
Email zsalkadhimi@uabmc.edu
Status Not yet recruiting
Phase Phase 2
Start date June 29, 2024
Completion date February 2027

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