Using azacitidine to improve donor chimerism in patients with myeloid malignancies after stem cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of azacitidine in patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) who have undergone allogeneic stem cell transplantation (SCT). The study aims to determine if azacitidine can be safely administered after SCT to reduce the rate of decreasing donor chimerism, which is associated with relapse, without increasing the risk of graft-versus-host disease (GVHD). Eligible patients will be those who show a drop in chimerism levels post-transplant but do not have concurrent hematologic relapse. The trial will monitor the effects of azacitidine on chimerism and overall patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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
2. \>=30 -180 days post SCT and patients must have ANC\> 1000, PLT \> 50,000
3. Age 18-75 years old
4. Performance score of at least 70% by Karnofsky
5. Adequate kidney and liver function as demonstrated by:

   1. Creatinine clearance should be \>60 ml/min
   2. Total Bilirubin \<1.5, ALT/AST/Alk Phos \< 2.5 x normal. No evidence of chronic active hepatitis or cirrhosis.
6. 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.
7. Patient or patient's legal representative, parent(s) or guardian able to sign informed consent.
8. Patients must be off any prior chemotherapy, radiotherapy, or other investigational therapy within 2 weeks prior to start treatment

Exclusion Criteria:

1. Positive for HIV, HBsAg, HCV or other viral hepatitis or cirrhosis from any cause
2. Active or prior CNS leukemia, unless in complete remission for at least 2 months.
3. History of serious chronic mental disorder or drug-abuse accompanied by documented problems of compliance with therapeutic programs.
4. Uncontrolled infection
5. Grade III, IV graft versus host disease (GVHD

Where it's running

• Henry ford hospital
  Detroit, Michigan, United States Recruiting

Study contacts

• Study coordinator: shatha farhan, MD
• Email: SFARHAN1@HFHS.ORG
• Phone: 313 916 5002

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.