This phase II trial tests how well decitabine and cedazuridine (DEC-C) works in combination with venetoclax in treating acute myeloid leukemia (AML) in patients whose AML has come back after a period of improvement (relapse) after a donor stem cell transplant. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving DEC-C in combination with venetoclax may kill more cancer cells in patients with relapsed AML.
PRIMARY OBJECTIVE: I. To assess the effect of DEC-C/venetoclax on the investigator-assessed composite complete remission (CR) rate (CR/complete remission with partial hematologic recovery \[CRh\]/complete remission with incomplete hematologic recovery \[CRi\]). SECONDARY OBJECTIVES: I. To assess the rate of partial response (PR) and morphologic leukemia free state (MLFS) following treatment with DEC-C/venetoclax. II. To assess the relapse free survival of patients treated with DEC-C/venetoclax. III. To assess overall survival of patients treated with DEC-C/venetoclax. IV. To assess the safety and tolerability of DEC-C/venetoclax in the post-hematopoietic cell transplant (HCT) setting. V. To assess the rates of measurable residual disease negativity in patients achieving a CR. OUTLINE: Patients receive venetoclax orally (PO) daily for 28 days in a 28-day cycle. Patients receive DEC-C PO daily on days 1-5 of a 28-day cycle. Patients undergo bone marrow biopsy and aspiration and blood sample collection throughout the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Given by mouth
Given by mouth
Given by mouth
Undergo bone marrow biopsy
Undergo blood sample collection
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
Number of Participants That Achieved a Complete Response to Therapy
Time frame: 9 months
Number of Participants That Achieved a Partial Response to Therapy
Time frame: 9 months
Rate of Morphologic Leukemia Free State (MLFS) Following Treatment With DEC-C/Venetoclax
Time frame: Up to 24 months post-treatment.
Rate of Relapse Free Survival
Relapse free survival was estimated by the Kaplan-Meier Method
Time frame: Up to 24 months post-treatment.
Rate of Overall Survival
Overall survival was estimated using the Kaplan-Meier method.
Time frame: Up to 24 months post-treatment.
Number of Treatment-related Adverse Events
List of adverse events that were attributed as related to study treatment is reported. All occurrences of a particular adverse event is reported.
Time frame: The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.
Rate of Measurable Residual Disease Negativity in Patients Achieving a CR
Time frame: Up to 24 months post-treatment.
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