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

This study is testing a new way to give a medicine called ATG (anti-thymocyte globulin) to help prevent acute GVHD (graft versus host disease) after an allogeneic stem cell transplant. GVHD is when the new immune cells from the donor attack your body. The study is for people aged 18-75 with acute leukemia, myelodysplastic syndrome, or myeloproliferative disorders who are receiving a stem cell transplant from a related or unrelated donor. You would receive prednisone and ATG infusions on specific days before your transplant. The main goal is to see how well this new ATG dosing prevents GVHD and relapse (when the cancer comes back) one year after transplant. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 56 participants. The study is testing a specific dosing platform of ATG combined with standard tacrolimus and mini methotrexate.
What's involved
You would be admitted to the hospital on Day -8 to receive prednisone, and then receive ATG infusions on Days -7, -6, -5, and -1 before your transplant.
Compensation
Not stated in the trial record.
Follow-up
The study will measure outcomes at one year post-transplant to see the rate of GRFS (GVHD and relapse-free survival).

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NCT06265584

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

Recruiting
PHASE2Ages 18–75InterventionalTreatment
University of Alabama at Birmingham
~56 participants
Updated 2025-10-08 on ClinicalTrials.gov
What's tested:ATG dosing platform when combined with standard tacrolimus and mini methotrexate

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of GRFS (graft versus host disease GVHD, relapse free survival) at one year post transplant.
Measured over 1 year post transplant
Acute Leukemia
Myelodysplastic Syndrome
Myeloproliferative Disorders
1 sites across 1 states
Alabama1
  • Zaid Al Kadhimi, MD · PRINCIPAL_INVESTIGATOR · The University of Alabama at Birmingham

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  • Rate of GRFS (graft versus host disease GVHD, relapse free survival) at one year post transplant.1 year post 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.