ATG Dosing for GVHD Prevention

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

What's the purpose of the trial?

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 GVHD/relapse free survival at one year post transplant.
Trial status

Not yet accepting

Phase
Phase 2
Enrollment
56
Last Updated
2 weeks ago
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Participating Centers

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Experimental Treatments

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  • Antithymocyte Globulin (ATG) is an antibody preparation made from rabbits or horses immune cells altered with human thymocytes. ATG is used to prevent or treat acute cellular rejection after solid organ transplantation and as a therapy for certain other blood disorders.
  • Fludarabine is a chemotherapy medication that may be used in the treatment of many different cancers.
  • Melphalan is a chemotherapy medication used in the treatment of different cancers.
  • Methotrexate is a chemotherapy medication that may be used in the treatment of many different cancers.
  • Tacrolimus is an immunosuppressive medication used to help prevent rejection in patients who have had a transplant.

Arms / Cohorts

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ATG Dosing

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