Actively Recruiting
Oral Azacitidine in Transplant-Eligible Patients With Acute Myeloid Leukemia (AML) Suffering From Health-Inequality
Led by Virginia Commonwealth University · Updated on 2026-03-02
12
Participants Needed
1
Research Sites
220 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Test feasibility of an oral maintenance strategy for transplant eligible AML patients in first CR who are medically underserved or have a disadvantage in the CDC SDOH domains
CONDITIONS
Official Title
Oral Azacitidine in Transplant-Eligible Patients With Acute Myeloid Leukemia (AML) Suffering From Health-Inequality
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed non-Acute Promyelocytic FLT3 negative AML
- Completed induction and consolidation therapy and currently in complete or partial remission
- AML phenotype eligible for allogeneic hematopoietic cell transplant (allo HCT) as per physician assessment
- Medically eligible for allo HCT with HCT-CI index of 5 or less or physician discretion
- Age 18 years or older
- Enrollment within 4 months of completing therapy
- Identified disadvantage in at least one CDC social determinants of health domain (e.g., financial, caregiver support, medical literacy, rurality, healthcare access, donor availability, substance abuse)
- Adequate organ function (creatinine clearance ≥29 mL/min, bilirubin and AST/ALT ≤2x institutional upper limit except Gilbert's syndrome)
- ECOG performance status 0 to 3
- Ability to take oral medications
- No history of malabsorption syndrome affecting oral medication absorption
- Women of childbearing potential must agree to effective contraception during treatment and for 6 months after
- Male patients must agree to effective contraception during treatment and for 3 months after
- Ability to understand and sign informed consent
You will not qualify if you...
- Presence of FLT3 ITD or TKD mutations
- Uncontrolled central nervous system involvement
- History of allergic reaction to azacitidine or its components
- Stem cell transplant within 3 months before starting study therapy
- Uncontrolled illness or infection
- Prior treatment with oral azacitidine
- Pregnant women or those intending to donate eggs during or within 6 months after treatment
- Male patients intending to donate sperm during or within 3 months after treatment
- Current therapy for other malignancies (except excisable skin cancer)
- Any medical, psychological, or social condition that increases risk or limits adherence as per investigator opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
Research Team
M
Massey IIT Research Operations
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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