Actively Recruiting
Trial of 2 Step ATG for Acute GVHD Prevention Post Myeloablative Allogeneic Stem Cell Transplant
Led by University of Alabama at Birmingham · Updated on 2025-10-08
29
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to test whether the combination of the drugs called tacrolimus (Tac), methotrexate (MTX) and new dosing strategy of another drug called (rabbit Anti-thymocyte Globulin \[ATG\]) will help prevent the development and/or improve severity of acute and/or chronic GVHD.
CONDITIONS
Official Title
Trial of 2 Step ATG for Acute GVHD Prevention Post Myeloablative Allogeneic Stem Cell Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult male or female aged 18 to 60 years
- Have a related or unrelated peripheral blood stem cell donor meeting specific HLA matching and donation eligibility criteria
- Candidate for myeloablative preparative regimen based on age 260 or HCT-CI of 24 and physician assessment
- Cardiac ejection fraction of at least 45%
- Calculated creatinine clearance greater than 50 mL/min
- Pulmonary function with DLCO and FEV1 of at least 50%
- Liver function with total bilirubin under 1.5 times normal (up to 3 mg/dl allowed for Gilbert's Disease) and ALT/AST under 2.5 times normal
- Female subjects must use two effective contraception methods or abstain from heterosexual intercourse from consent through 12 months post-transplant unless postmenopausal or surgically sterilized
- Male subjects must use effective barrier contraception or abstain from heterosexual intercourse from consent through 12 months post-transplant
- Karnofsky performance status (KPS) of at least 80
- Diagnosis of acute myeloid leukemia in remission with intermediate or high risk of relapse, myelodysplastic syndrome with intermediate-low or higher risk, chronic myeloproliferative disorders with progression or high risk, chronic myelomonocytic leukemia with high or intermediate risk, or acute lymphoblastic leukemia with high relapse risk
- Willing and able to sign informed consent and follow study requirements
You will not qualify if you...
- Autologous hematopoietic stem cell transplant within 3 months prior to enrollment
- Residual acute myeloid leukemia with more than 5% blasts in marrow or circulating blasts
- Previous allogeneic stem cell transplant
- Uncontrolled angina, severe ventricular arrhythmias, or acute ischemic heart conditions
- Known allergy or hypersensitivity to ATG
- Use of investigational drugs within 14 days before transplant conditioning
- Pregnant or breastfeeding
- Evidence of HIV infection
- Current uncontrolled bacterial, viral, or fungal infection with worsening symptoms or findings
- Non-hematologic cancer within past 3 years except certain skin cancers
- Participation in another clinical study with investigational product within the last 28 days
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
Research Team
Z
Zaid S Al Kadhimi, MD
CONTACT
M
Margaret A 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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