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The primary outcome for the study is GRFS rate at one-year post transplant. GRFS will be estimated using Kaplan Meier method The reported GRFS with recent phase III trial of PTCY/tac/MMF in transplant from matched related and unrelated donors at 1 year follow up was 52%. We hypothesize that with 2 step ATG/Tac/Mini MTX regimen, we can achieve a one year GRFS of 69%.

On Day -8, you will be admitted to the hospital and receive a dose of prednisone at 1 mg/kg (ATG premedication). You will receive a steroids 3 hours before every ATG infusion. On day -7, you will receive a small dose of ATG as an intravenous (IV) infusion. ATG will be repeated on days -6, -5 and -1. Routine transplant chemotherapy agent fludarabine will be given on days -7 to -3 as daily IV infusions. Melphalan, another routine transplant chemotherapy will be given on day -4 as IV infusion. Tacrolimus (standard immune suppression agent) will start on day -3 as continuous IV infusion and switched to oral after engraftment. Methotrexate is another standard immune suppression medication which is given IV on day +1, +3, +6, and +11 post-transplant. We plan to draw blood on days -4,, -1, +3, +7, and +14 to measure ATG levels.

ATG dosing platform when combined with standard tacrolimus and mini methotrexate

Zaid S Al Kadhimi, MD

Margaret Thomas, MPH

Zaid Al Kadhimi, MD

Manuel Espinoza-Gutarra, MD

Donna Salzman, MD

Antonio Di Stasi, MD

Lauren Shea, MD

Omar Jamy, MD

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

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

Rate of GRFS is defined as the time from date of first dose of fludarabine until occurrence of grade III-IV aGVHD, and or cGVHD requiring systemic immune suppression, and or disease progression or death whichever comes first.

University of Alabama at Birmingham

Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Trial of 2 Step ATG for Prevention of Acute GVHD Post Allogeneic Stem Cell Transplant	NCT06265584	Acute Leukemia Myelodysplastic... Myeloproliferat...	ATG dosing plat...	18 Years - 75 Years	University of Alabama at Birmingham
Trial of 2 Step ATG for Prevention of Acute GVHD Post Allogeneic Stem Cell Transplant	NCT06265584	Acute Leukemia Myelodysplastic... Myeloproliferat...	ATG dosing plat...	18 Years - 75 Years	University of Alabama at Birmingham

Spots Global Cancer Trial Database for atg dosing platform when combined with standard tacrolimus and mini methotrexate