OHSU Knight Cancer Institute
This phase II trial tests how well venetoclax with cladribine and cytarabine alternating with azacitidine and venetoclax works in treating patients with newly diagnosed monocytic acute myeloid leukemia (AML) and active signaling mutated AML. 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. Chemotherapy drugs, such as cladribine, cytarabine 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. Giving venetoclax with cladribine and cytarabine alternating with azacitidine and venetoclax may kill more cancer cells in patients with newly diagnosed monocytic AML and active signaling mutated AML.
PRIMARY OBJECTIVE: I. Assess efficacy of the investigational treatment based on disease remission. SECONDARY OBJECTIVES: I. Assess efficacy of the investigational treatment based on clinical response. II. Assess any-cause survival after treatment. III. Assess survival in the absence of treatment failure, hematologic relapse, or progressive disease. IV. Assess duration of response, based on morphological assessments. V. Assess the safety and tolerability of the regimen. EXPLORATORY OBJECTIVES: I. Assess response based on measurable residual disease (MRD). II. Identify markers of clonal or…
Inclusion Criteria: * Ability to comprehend the investigational nature of the study and provide informed consent (i.e., participant or legally authorized representative \[LAR\]). Written informed consent must be obtained prior to any study-specific procedures or interventions • Sign informed consent for the #4422 Biorepository prior to any study-specific procedures of interventions * Eligible AML patients of all races and ethnic groups will be considered for participation, irrespective of gender identity * Newly diagnosed, histologically confirmed monocytic AML, as defined by World Health…
Given IV or SC
Undergo blood sample collection
Undergo bone marrow aspiration and biopsy
Undergo bone marrow aspiration and biopsy
Given IV
Given SC
Undergo ECHO
Undergo LP
Undergo MUGA
Ancillary studies
Given PO