RecruitingPhase 2NCT06315309

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

Phase II Clinical Trial of 2 Step ATG Combined With Tacrolimus and Mini Methotrexate for Prevention of Acute GVHD Post Myeloablative Allogeneic Stem Cell Transplant


Sponsor

University of Alabama at Birmingham

Enrollment

29 participants

Start Date

Apr 15, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a two-step anti-thymocyte globulin (ATG) dosing strategy to prevent a serious complication called graft-versus-host disease (GvHD) after an allogeneic (donor) stem cell transplant. GvHD happens when the donor's immune cells attack the patient's body, and ATG is a drug that suppresses this immune response. **You may be eligible if...** - You are between 18 and 60 years old - You have a blood cancer or other condition requiring a myeloablative (high-intensity) stem cell transplant - You have a matched related (sibling, 6/6 HLA match) or matched unrelated (8/8 HLA match) donor who is willing and medically able to donate peripheral blood stem cells - Your overall health and treatment history make you a suitable candidate for myeloablative conditioning (high-dose chemotherapy/radiation before transplant) **You may NOT be eligible if...** - You do not have a suitably matched donor - You are over 60 years old or have significant health problems that make intensive conditioning unsafe - You have had a prior allogeneic transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGATG Combined with Tacrolimus and Mini Methotrexate

On Day -7, subjects will be admitted to the hospital and receive a dose of prednisone at 1 mg/kg (ATG premedication). Subjects will receive a steroid injection 3 hours before every ATG infusion. On day -6, subjects will receive a small dose of ATG as an IV infusion. ATG will be repeated on days -5,-4 and -1. Routine transplant chemotherapy agent fludarabine will be given on days -6 to -2 as daily IV infusions. Busulfan, a routine transplant chemotherapy will be given on days -5 to -2 as IV infusion. Subjects with lymphoblastic leukemia will receive an alternative regimen of cyclophosphamide, a routine chemotherapy on days -6 and -5, followed by total body radiation on days -3 to -1. Tacrolimus (standard immune suppression agent) starts on day -3 as continuous IV infusion and switched to oral after engraftment. Methotrexate a standard immune suppression medication which is given IV on day +1,+3,+6, and +11 post-transplant. Blood draws on days -4,-1,+3,+7,+14 to measure ATG levels.


Locations(1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

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NCT06315309


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