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Study of 2-Step ATG for GVHD Prevention After Stem Cell Transplant

This study is testing a new way to give a drug called rabbit Anti-thymocyte Globulin (ATG) along with tacrolimus (Tac) and methotrexate (MTX). The goal is to see if this combination can better prevent or reduce the severity of acute (sudden and severe) and chronic (long-lasting) Graft-versus-Host Disease (GVHD) after an allogeneic stem cell transplant. GVHD is a complication where the new immune cells from the donor attack the patient's body. The study is looking to see if this treatment is successful in preventing severe GVHD and improving survival one year after transplant. You may be able to join if you are between 18 and 60 years old and need a stem cell transplant for certain blood cancers like acute leukemia or myelodysplastic syndromes, and have a suitable donor.

Study design
This interventional study plans to enroll 29 participants. The phase of the study is not specified.
What's involved
On Day -7, you would be admitted to the hospital and receive prednisone. You would also receive a steroid injection before each ATG infusion, with a small dose of ATG given on Day -6.
Compensation
Not stated in the trial record.
Follow-up
The study will measure therapeutic success at one year post transplant.

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NCT06315309

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

Recruiting
PHASE2Ages 18–60InterventionalTreatment
University of Alabama at Birmingham
~29 participants
Updated 2025-10-08 on ClinicalTrials.gov
What's tested:ATG Combined with 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
To estimate the therapeutic success of 2-step ATG dosing platform in patients undergoing reduced intensity allogeneic transplantation for treatment of hematologic malignances
Measured over 1 year post transplant

Conditions

GVHD,Acute
Acute Leukemia
Myelodysplastic Syndromes
Myeloproliferative Disorders

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Where it's being run

1 sites across 1 states
Alabama1

Who to contact

Zaid S Al Kadhimi, MD
[email protected]
205-975-1269
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

B-cell ALL: High white blood cell count at diagnosis (ie, \>30,000/µl), Clonalcytogenetic abnormalities - t(4;11), t(1;19), t(9;22), or BCR-ABL gene positivity, BCR-ABL1-like (Ph-like) gene signature, progenitor-B cell immunophenotype (eg, blasts expressing membrane CD19, CD79a, and cytoplasmic CD22, but not CD10), Length of time from start of induction therapy to attainment of CR greater than four weeks, and minimal residual disease (MRD) post-remission bone marrow MRD+.(Akabane \& Logan, 2020; Lafage-Pochitaloff et al., 2017)
T-cell ALL: Failure to achieve CR after one induction, MRD\> 1X 10-4 after 2 courses of induction, Presenting WBC \> 100 X 109/L, complex cytogenetics ≥5,early T-cell Precursor ALL, poor risk genetics including lack of NOTCH1 ith/FBXW7 or presence of N-RAS \& K-RAS, EZH2 and age\>40 years.(Marks \& Rowntree, 2017) G- ALL in \>CR1 12. The subject is willing and able to sign informed consent and abide by the protocol requirements.

What this trial measures

  • To estimate the therapeutic success of 2-step ATG dosing platform in patients undergoing reduced intensity allogeneic transplantation for treatment of hematologic malignances1 year post transplant

    Rate of GRFS (graft versus host disease GVHD, relapse free survival) at one year post transplant. To meet that end point the patient needs to be alive without relapse, or grade III-IV acute GVHD, or chronic GVHD requiring systemic immune suppression.