Trial of 2 Step ATG for Prevention of Acute GVHD Post Allogeneic Stem Cell Transplant

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 recon

Trial Details

NCT ID
NCT06265584
Phase
PHASE2
Sponsor
University of Alabama at Birmingham
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • ATG dosing platform when combined with standard tacrolimus and mini methotrexate
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249

Key Eligibility Criteria

  • Adult male or female, age 18-75 years
  • Patients must have a related or unrelated peripheral blood stem cell donor. Sibling donor must be a 6/6 match for HLA-A and -B at intermediate (or …
  • A candidate for reduced intensity preparative regimen, based on age≥60, or HCT-CI of ≥4, or considered by the treating physician to have high risk …
  • Cardiac function: Ejection fraction \>40%

For full eligibility, visit ClinicalTrials.gov.

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