This phase II trial studies how well azacitidine and venetoclax work in treating patients with acute myeloid leukemia that is in remission. Drugs used in chemotherapy, such as azacitidine and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
PRIMARY OBJECTIVES: I. To assess relapse-free survival (RFS) of patients (pts) with acute myeloid leukemia (AML) treated with 5-azacytidine (azacitidine; AZA) combined with venetoclax (VEN) as maintenance therapy after achieving remission. SECONDARY OBJECTIVES: I. To assess modified RFS of pts with AML treated with 5-azacytidine combined with venetoclax as maintenance therapy. II. To assess overall survival (OS) of pts with AML treated with 5-azacytidine combined with venetoclax as maintenance therapy. III. To assess event-free survival (EFS) of pts with AML treated with 5-azacytidine combined with venetoclax as maintenance therapy. IV. To assess the duration of remission (CRd) of pts with AML treated 5-azacytidine combined with venetoclax as maintenance therapy. V. To assess toxicity and safety of 5-azacytidine combined with venetoclax as maintenance therapy in pts with AML. VI. To assess the effects of 5-azacytidine combined with venetoclax on dynamics of minimal residual disease (MRD) and their relationship to outcomes. OUTLINE: Patients receive azacitidine subcutaneously (SC) or intravenously (IV) over 1 hour daily on days 1-5, and venetoclax orally (PO) daily on days 1-14. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 6-12 months thereafter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Given SC or IV
Given PO
M D Anderson Cancer Center
Houston, Texas, United States
Relapse-free survival (RFS)
The study will be continuously monitored for the primary endpoint, RFS, using the method of Thall, Wooten, and Tannir (2005). Will also summarize the posterior distribution of lambda-E (i.e., median RFS) assuming posterior mean and 95% credible interval.
Time frame: From date of complete remission (CR) or complete remission with incomplete count recovery (CRi), assessed for up to 10 years
Incidence of toxicity
Toxicities are defined as any treatment -related clinically significant grade 3 or 4 non-hematologic adverse events occurred during cycles 1-2 of the trial. Will continuously monitor treatment-related toxicities using the Bayesian approach of Thall, Simon, Estey (1995).
Time frame: Up to 10 years
Modified RFS
Distribution assessed using Kaplan-Meier method.
Time frame: Time from enrollment on study until date of first objective documentation of relapse or death, assessed for up to 10 years
Overall survival (OS)
Distribution assessed using Kaplan-Meier method.
Time frame: From the start of study treatment until date of death due to any cause, assessed for up to 10 years
Event free survival (EFS)
Distribution assessed using Kaplan-Meier method.
Time frame: From the start of study treatment until date of first confirmed relapse, withdrawal from study due to adverse event, or death due to any cause, assessed for up to 10 years
Complete remission duration (CRd)
Distribution assessed using Kaplan-Meier method.
Time frame: Time from CR or CRi until date of first objective documentation of confirmed relapse, assessed for up to 10 years
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