Azacitidine and Chimerism in MDS or AML Patients After Allogeneic Stem Cell Transplant

Study Overview
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Brief Summary
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Previous studies provide a rationale for administration of AZA after allo SCT for decreasing chimerism. The investigators hypothesize that azacitidine can be well tolerated after SCT and help decrease rate of decreasing donor chimerism and hence decrease relapse without increasing GVHD

Official Title
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Azacitidine and Chimerism in MDS or AML Patients After Allogeneic Stem Cell Transplant

Conditions
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Myeloid Malignancy

Intervention / Treatment
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* Drug: azacitidine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZA<br>azacitidine | Drug: azacitidine<br>* azacitidine 32mg/m2 x 5 days every 28 days for minimum of 4 cycles if tolerated<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of increase or stable donor chimerism | To determine the rate of increase or stable donor chimerism when using low dose azacitidine post allogenic stem cell transplant (SCT) in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML) and myeloproliferative neoplasms (MPN) with documented low or decreasing donor chimerism | one year |