NCT03850418 · Henry Ford Health System
Azacitidine and Chimerism in MDS or AML Patients After Allogeneic Stem Cell Transplant
What this study is about
Previous studies provide a rationale for administration of AZA after allo SCT for decreasing chimerism.
View original scientific description
Previous studies provide a rationale for administration of AZA after allo SCT for decreasing chimerism.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients with AML/MDS/MPN, CMML post Allogeneic SCT who experience any drop in total or myeloid chimerism any time after day 30, or their day 30 or day100 myeloid donor chimerism is below 98% without concurrent hematologic relapse (that is, patients with \<5% bone marrow blasts as obtained at that time point) will be offered treatment with azacitidine
- \>=30 -180 days post SCT and patients must have ANC\> 1000, PLT \> 50,000
- Age 18-75 years old
- Performance score of at least 70% by Karnofsky
- Adequate kidney and liver function as demonstrated by:
- Creatinine clearance should be \>60 ml/min
- Total Bilirubin \<1.5, ALT/AST/Alk Phos \< 2.5 x normal. No evidence of chronic active hepatitis or cirrhosis.
- Negative Beta HCG test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Women of child bearing potential must be willing to use an effective contraceptive measure while on study.
- Patient or patient's legal representative, parent(s) or guardian able to sign informed consent.
- Patients must be off any prior chemotherapy, radiotherapy, or other investigational therapy within 2 weeks prior to start treatment
Exclusion criteria
- Positive for HIV, HBsAg, HCV or other viral hepatitis or cirrhosis from any cause
- Active or prior CNS leukemia, unless in complete remission for at least 2 months.
- History of serious chronic mental disorder or drug-abuse accompanied by documented problems of compliance with therapeutic programs.
- Uncontrolled infection
- Grade III, IV graft versus host disease (GVHD
Where
- Detroit, Michigan
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 24, 2026 · Source of record for eligibility and locations