National Cancer Institute (NCI)
This phase I trial tests safety, side effects and best dose of iadademstat with azacitidine and venetoclax for the treatment of patients with acute myeloid leukemia (AML) who have not received treatment (treatment naive). Chemotherapy drugs, such as iadademstat and azacitidine 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. 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 iadademstat with azacitidine and venetoclax may be safe and tolerable in treating patients with treatment naive AML.
PRIMARY OBJECTIVE: I. To determine the recommended phase 2 dose (RP2D) and safety profile of iadademstat in combination with venetoclax and azacitidine. SECONDARY OBJECTIVES: I. To observe and record anti-tumor activity, including evaluating the overall response rate (ORR), defined as complete remission (CR), CR with incomplete hematologic recovery (Cri), or CR with partial hematologic recovery (CRh). II. To evaluate the measurable residual disease (MRD)-negative composite CR (cCR) rate after 1, 2, and 3 cycles using multiparameter flow cytometry (MFC) and evaluate event-free survival (EFS…
Inclusion Criteria: * Patients must have established and confirmed diagnosis of intermediate or adverse-risk AML according to the European LeukemiaNet 2022 classification criteria * Previously untreated AML excluding hydroxyurea and all-trans retinoic acid (ATRA). ATRA would only be used for suspected AML * Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of iadademstat in combination with venetoclax and azacitidine in patients \< 18 years of age, children are excluded from this study * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2…
Given IV or SC
Undergo collection of blood samples
Undergo blood sample collection
Undergo bone marrow aspiration
Undergo buccal swab
Given PO
Given PO