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Recruiting Phase 2 NCT06315309

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

Trial Parameters

Condition GVHD,Acute
Sponsor University of Alabama at Birmingham
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 29
Sex ALL
Min Age 18 Years
Max Age 60 Years
Start Date 2025-04-15
Completion 2026-12
Interventions
ATG Combined with Tacrolimus and Mini Methotrexate

Brief Summary

The 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.

Eligibility Criteria

Inclusion Criteria: 1. Adult male or female, age 18-60 years 2. 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 higher) resolution, and -DRB1 at high resolution using DNA-based typing, and must be willing to donate peripheral blood stem cells and meet institutional criteria for donation. Unrelated donor must be 8/8 match at HLA-A, -B, -C and -DRB1 at high resolution using DNA-based typing. Unrelated donor must be willing to donate peripheral blood stem cells and be medically eligible to donate stem cells according to NMDP criteria. 3. A candidate for Myeloablative preparative regimen, based on age ≤ 60, or HCT-CI of ≤ 4, and considered by the treating physician to be a candidate for such regimen. 4. Cardiac function: Ejection fraction ≥ 45% 5. Calculated creatinine clearance greater than 50 mL/minute (using the Cockcroft-Gault formula and actual body weight). 6. Pulmonary function: DLCO ≥

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