The purpose of this study is to find out if oral decitabine-cedazuridine (Inqovi®) is effective, safe, and able to be tolerated without severe side effects when given with thioguanine (Tabloid®) in patients with acute myeloid leukemia (AML) whose disease has returned or did not respond to treatment (relapsed or refractory). This is a "phase II trial with a safety lead-in." The goal of the lead-in portion of the study is to make sure participants are getting the highest dose of medications that are safe. If too many serious side effects are seen with the dose previously studied, some additional patients may be treated with a lower dose to make sure that this dose is safe.
Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow with a 5-year survival rate of 47.5% for patients less than age 65 years and only an 8.2% survival for those 65 and older, based on data from the Surveillance, Epidemiology, and End Results (SEER) program of the National Cancer Institute. Despite some advances in treatment, most patients will relapse, and treatment remains limited, especially for patients that progress on the standard of care. The expected response rate to salvage chemotherapy is only 10-20% with a median survival typically of less than 6 months. The need for new, effective, and well-tolerated treatments is clear.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
60-80mg/m\^2 oral tablet
35 mg decitabine and 100 mg cedazuridine oral tablet
Composite Complete Remission (CRc) Rate
This rate will be calculated from rate of complete remission (CR) plus CR with partial hematologic recovery (CRh) plus CR with incomplete hematologic recovery (CRi), according to the European LeukemiaNet (ELN) 2022 criteria.
Time frame: Up to 3 years
Duration of Remission
This is defined as the time from CRc until relapse or death from any cause, whichever is first.
Time frame: Up to 3 years
Time to Complete Remission (CR)
This is defined as time from therapy initiation until CRc.
Time frame: Up to 3 years
Overall Survival (OS)
This is defined as the duration of time from randomization to death from any cause.
Time frame: Up to 3 years
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