OncoMatch/Clinical Trials/NCT06265584
Trial of 2 Step ATG for Prevention of Acute GVHD Post Allogeneic Stem Cell Transplant
Is NCT06265584 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies ATG dosing platform when combined with standard tacrolimus and mini methotrexate for acute leukemia.
Treatment: ATG dosing platform when combined with standard tacrolimus and mini methotrexate — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Myelodysplastic Syndrome
Biomarker criteria
Required: FLT3 ITD (+) without MPN1
FLT3-ITD (+) without MPN1
Required: TP53 mutation positive
P53 mutation positive
Required: ASXL1 mutation
ASXL1+
Required: RUNX1 mutant
mutant RUNX1
Required: TP53 mutation
MDS with P-53 or JAK2 mutation
Required: JAK2 mutation
MDS with P-53 or JAK2 mutation
Prior therapy
Cannot have received: autologous hematopoietic stem cell transplant
Exception: if < 3 months prior to enrollment
Autologous hematopoietic stem cell transplant < 3 months prior to enrollment
Cannot have received: allogeneic stem cell transplant
Previous allogeneic stem cell transplant
Cannot have received: investigational drug
Exception: if received within 14 days prior to first day of transplant conditioning
Received any investigational drugs within the 14 days prior to the first day of transplant conditioning
Lab requirements
Kidney function
creatinine clearance > 50 mL/min (Cockcroft-Gault formula, actual body weight)
Liver function
total bilirubin < 1.5x ULN (Gilbert's Disease allowed up to <3mg/dl); ALT/AST < 2.5x ULN
Cardiac function
Ejection fraction >40%
Cardiac function: Ejection fraction >40%; Measured creatinine clearance greater than 50 mL/minute (using the Cockcroft-Gault formula and actual body weight); Liver function: total bilirubin < 1.5x the upper limit of normal and ALT/AST < 2.5x the upper normal limit. Patients who have been diagnosed with Gilbert's Disease are allowed to exceed the defined bilirubin value of up to <3mg/dl.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham · Birmingham, Alabama
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