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Monoclonal Antibodies

ATG Combination Therapy for Acute GVHD

Phase 2
Waitlist Available
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post transplant
Awards & highlights

Summary

This trial aims to see if combining three drugs, tacrolimus, methotrexate, and rabbit Anti-thymocyte Globulin (ATG), with a new dosing strategy, can help

Who is the study for?
This trial is for individuals with conditions like Myelodysplastic Syndrome, Preleukemia, or Acute Leukemia who are undergoing a myeloablative allogeneic stem cell transplant. The goal is to prevent acute Graft-versus-Host Disease (GVHD). Specific eligibility criteria details were not provided.
What is being tested?
The study tests if using Anti-thymocyte Globulin (ATG) in a new dosing strategy along with Tacrolimus and Mini Methotrexate can prevent or lessen the severity of acute and/or chronic GVHD after stem cell transplant.
What are the potential side effects?
Potential side effects may include immune system suppression leading to increased infection risk, reactions related to infusion of ATG, liver function changes due to Tacrolimus, and mouth sores or low blood counts from Methotrexate.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To estimate the therapeutic success of 2-step ATG dosing platform in patients undergoing reduced intensity allogeneic transplantation for treatment of hematologic malignances

Trial Design

1Treatment groups
Experimental Treatment
Group I: phase II single arm study of 2 step ATG dosing in prevention of aGVHD.Experimental Treatment1 Intervention
The primary outcome for the study is rate of GRFS at one-year post transplant. When accounting for competing risks, any death, relapse, Grade III-IV acute GVHD and cGVHD requiring systemic therapy are competing risks. The reported one year GRFS with the use of standard of care GVHD prevention regimen in MA HSCT (Tac/MTX) was 35%. (El-Jurdi 2023) We hypothesize that with 2 step ATG/Tac/Mini MTX regimen, we can achieve a one year GRFS of 60%.

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Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,621 Previous Clinical Trials
2,290,949 Total Patients Enrolled
~19 spots leftby Oct 2025
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