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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZA | Experimental | azacitidine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| azacitidine | Drug | azacitidine 32mg/m2 x 5 days every 28 days for minimum of 4 cycles if tolerated |
|
| 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 |
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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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| shatha farhan, MD | Contact | 313 916 5002 | SFARHAN1@HFHS.ORG | |
| NALINI JANAKIRAMAN, MD | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry ford hospital | Recruiting | Detroit | Michigan | 48202 | United States |
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| ID | Term |
|---|---|
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |