Test feasibility of an oral maintenance strategy for transplant eligible AML patients in first CR who are medically underserved or have a disadvantage in the CDC SDOH domains
This is a non-randomized open-label single institution pilot study that will evaluate the feasibility, toxicity, and efficacy of maintenance oral azacitidine in medically transplant eligible non-FMS-like tyrosine kinase 3 (FLT3) mutated AML patients with a disadvantage in at least 1 of the 5 key Center for Disease Control and Prevention (CDC) defined social determinants of health (SDOH) domains that are preclusive to transplant at time of study enrollment, as identified either by the patient or a member of the healthcare team.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Oral Azacitidine, 300mg PO Daily during days 1-14 of a 28 day cycle for up to 6 cycles.
Virginia Commonwealth University
Richmond, Virginia, United States
RECRUITINGRate of completion of at least 4 cycles an oral maintenance strategy for transplant eligible AML patients in CR who are medically underserved or have a disadvantage in the CDC SDOH domains
The number of participants that complete at least four cycles of protocol therapy
Time frame: 4 months
Overall survival (OS)
Number of participants alive at relapse, completion of treatment or removal from study.
Time frame: 3 months, and up to 2 years
Leukemia Free Survival (LFS) 3 months after beginning of treatment and at relapse, completion of treatment or removal from study
Number of participants still in remission 3 months after beginning of treatment and at relapse, completion of treatment or removal from study
Time frame: 3 months, and up to 2 years
Measure rates of measurable residual disease (MRD) negativity
The number of participants that have negative measurable residual disease (MRD) at 3 months after beginning of treatment, and completion of treatment. MRD will be measured by flow cytometry and by pathologic complete response (PCR) based molecular assay if/when target gene is available on diagnostic specimen.
Time frame: 3 months, and up to 2 years
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