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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year post transplant

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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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