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OncoMatch/Clinical Trials/NCT06315309

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

Is NCT06315309 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies ATG Combined with Tacrolimus and Mini Methotrexate for gvhd,acute.

Phase 2RecruitingUniversity of Alabama at BirminghamNCT06315309Data as of May 2026

Treatment: ATG Combined with Tacrolimus and Mini MethotrexateThe purpose of this study is to test whether the combination of the drugs called tacrolimus (Tac), methotrexate (MTX) and new dosing strategy of another drug called (rabbit Anti-thymocyte Globulin \[ATG\]) will help prevent the development and/or improve severity of acute and/or chronic GVHD.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Myelodysplastic Syndrome

Prior therapy

Cannot have received: autologous hematopoietic stem cell transplant

Exception: allowed 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

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 ≥ 45%

Cardiac function: Ejection fraction ≥ 45%; Calculated 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 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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