Actively Recruiting
Azacitidine and Chimerism in MDS or AML Patients After Allogeneic Stem Cell Transplant
Led by Henry Ford Health System · Updated on 2026-02-24
43
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying azacitidine in patients with myeloid malignancies such as AML or MDS who have undergone allogeneic stem cell transplant. The study aims to see if azacitidine can be tolerated after transplant and help maintain or increase donor chimerism, potentially reducing relapse without increasing graft-versus-host disease (GVHD). This is a phase 2 interventional trial sponsored by Henry Ford Health System. Participants will receive azacitidine at a dose of 32 mg/m2 daily for 5 days every 28 days, for a minimum of 4 cycles if tolerated. The treatment is given after transplant once patients show a decrease in donor chimerism or low chimerism without relapse. The study monitors patients over at least one year. During the study, participants will be regularly evaluated for changes in donor chimerism levels, with the primary outcome being the rate of increase or stability of donor chimerism at one year. Safety and tolerability will also be assessed. Patients must meet specific health criteria and undergo laboratory monitoring to ensure kidney, liver function, and blood counts are adequate. The total study duration varies by treatment cycles and follow-up.
CONDITIONS
Brief Title
Azacitidine and Chimerism in MDS or AML Patients After Allogeneic Stem Cell Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Diagnosis of AML, MDS, MPN, or CMML after allogeneic stem cell transplant
- Experiencing a drop in total or myeloid donor chimerism after day 30 post-transplant or having day 30 or day 100 myeloid chimerism below 98% without relapse
- Between 30 and 180 days post stem cell transplant
- Absolute neutrophil count above 1000 and platelet count above 50,000
- Karnofsky performance score of at least 70%
- Adequate kidney function with creatinine clearance over 60 ml/min
- Adequate liver function with total bilirubin less than 1.5 and liver enzymes less than 2.5 times normal
- Negative Beta HCG test in women of childbearing potential; willingness to use effective contraception during study
- Able to provide informed consent or have a legal representative do so
- Off prior chemotherapy, radiotherapy, or investigational therapy for at least 2 weeks before treatment start
You will not qualify if you...
- Positive for HIV, hepatitis B surface antigen, hepatitis C virus, or other viral hepatitis; or cirrhosis from any cause
- Active or prior central nervous system leukemia unless in remission for at least 2 months
- History of serious chronic mental disorder or drug abuse with compliance problems
- Uncontrolled infection
- Grade III or IV graft versus host disease (GVHD)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Minimum of 4 cycles of 28 days each
Participants receive azacitidine at a dose of 32mg/m2 daily for 5 days every 28 days for a minimum of 4 cycles if tolerated.
5 daily visits every 28 days for at least 4 cycles
Trial Site Locations
Total: 1 location
1
Henry ford hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
Research Team
S
shatha farhan, MD
N
NALINI JANAKIRAMAN, MD
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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