Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06265584

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

Led by University of Alabama at Birmingham · Updated on 2025-10-08

56

Participants Needed

1

Research Sites

186 weeks

Total Duration

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AI-Summary

What this Trial Is About

In an effort to reduce graft versus host disease (GVHD) and enhance graft versus leukemia (GVL) effect post allogenic hematopoietic stem cell transplantation (AHSCT), recent research has focused on host immune cell depletion. Frame shifting anti-thymocyte globulin (ATG) backwards to earlier days before days 0 can result in deeper host and less graft T-cell depletion, leading to better immune reconstitution. Preliminary data where 80% of the ATG dose is given on days -6,-5,-4 and 20% given on day -1, showed effective prevention of severe acute GVHD, chronic GVHD and favorable early immune reconstitution. We hypothesize that our 2 step ATG dosing platform when combined with standard tacrolimus and mini methotrexate can prevent grade III-IV acute GVHD and chronic GVHD, resulting in improvement of GVHD/relapse free survival at one year post transplant.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult male or female, age 18-75 years
  • Have a related or unrelated peripheral blood stem cell donor meeting specific HLA matching criteria
  • Candidate for reduced intensity preparative regimen due to age 60 or older, high comorbidity index, or physician assessment of toxicity risk
  • Cardiac ejection fraction greater than 40%
  • Creatinine clearance greater than 50 mL/min using Cockcroft-Gault formula
  • Pulmonary function with DLCO and FEV1 at least 50%
  • Liver function with total bilirubin less than 1.5 times the upper limit of normal (up to 3 mg/dL allowed for Gilbert's Disease) and ALT/AST less than 2.5 times upper normal limit
  • Female subjects must use two effective contraception methods or abstain from heterosexual intercourse from consent through 12 months post-transplant unless postmenopausal for at least one year or surgically sterilized
  • Male subjects or their partners must use effective barrier contraception or abstain from heterosexual intercourse from consent through 12 months post-transplant
  • Karnofsky performance status of 70 or higher
  • Diagnosis of AML with specific disease features, MDS with specified high risk features, or myelofibrosis with blasts in peripheral blood
  • Willing and able to sign informed consent and follow study protocol
Not Eligible

You will not qualify if you...

  • Autologous hematopoietic stem cell transplant within 3 months prior to enrollment
  • More than 5% residual AML blasts in marrow or peripheral blood
  • Previous allogeneic stem cell transplant
  • Uncontrolled angina, severe arrhythmias, acute ischemia, or conduction abnormalities on EKG
  • Known hypersensitivity to study agents
  • Use of investigational drugs within 14 days before transplant conditioning
  • Pregnancy or breastfeeding
  • HIV infection or positive HIV serology
  • Current uncontrolled bacterial, viral, or fungal infection with progressive symptoms or findings
  • Documented cirrhosis
  • Non-hematologic malignancy within 3 years except certain skin cancers or treated cervical carcinoma in situ; cancers treated with curative intent within 5 years require PI approval
  • Participation in another investigational clinical study within 28 days before enrollment

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

Actively Recruiting

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Research Team

Z

Zaid Al Kadhimi, MD

CONTACT

M

Margaret Thomas, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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