Azacitidine and Chimerism in MDS or AML Patients After Allogeneic Stem Cell Transplant
ConditionMyeloid Malignancy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHenry Ford Health System
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
azacitidine
Drugazacitidine 32mg/m2 x 5 days every 28 days for minimum of 4 cycles if tolerated
Treatment groups
43 Participants
are divided into 1 treatment groupGroup A: AZAExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
one yearSponsors and contacts
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Source ClinicalTrials.gov