2 Step ATG

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

What will happen during the trial?

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.

More Information

Trial Status
Not yet accepting
Trial Phase
Phase 2
Enrollment
29 patients (estimated)
Sponsors
University of Alabama at Birmingham
Trial Type
Supportive
Last Update
1 week ago
SparkCures ID
1851
NCT Identifier
NCT06315309

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