protocolSection identificationModule nctId: NCT06357182, orgStudyIdInfo id: STUDY00026136, secondaryIdInfos id: NCI-2024-01262, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: STUDY00026136, type: OTHER, domain: OHSU Knight Cancer Institute, briefTitle: Iadademstat in Combination With Azacitidine and Venetoclax in Treating Newly Diagnosed Acute Myeloid Leukemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-08, primaryCompletionDateStruct date: 2026-03-08, completionDateStruct date: 2026-05-29, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: OHSU Knight Cancer Institute, class: OTHER, collaborators name: Oregon Health and Science University, collaborators name: Oryzon Genomics S.A., descriptionModule briefSummary: This phase I trial tests the safety, side effects, and best dose of iadademstat when given together with azacitidine and venetoclax in treating patients with newly diagnosed acute myeloid leukemia (AML). Iadademstat inhibits the LSD1 protein and may lead to inhibition of cell growth in LSD1-overexpressing cancer cells. Chemotherapy drugs, such as 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, tolerable and/or effective in treating patients with newly diagnosed AML who cannot undergo intensive chemotherapy., conditionsModule conditions: Acute Myeloid Leukemia, conditions: Myelodysplastic Syndrome/Acute Myeloid Leukemia, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: The treatment plan starts with a 7 day monotherapy lead-in (Cycle 0 \[C0\]) and then proceeds to combination therapy in 28 day cycles. Disease will be assessed pre-treatment (Screening/Baseline), at the end of monotherapy, in C1 (and C2, if response is not observed in C1), and at the end of alternating cycles, thereafter. A disease assessment will also be conducted within 30 days of the last dose of IADA. Participants that do not achieve response after up to 2 cycles of the triplet regimen will be taken off treatment., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Azacitidine, interventions name: Biospecimen Collection, interventions name: Bone Marrow Biopsy, interventions name: Echocardiography, interventions name: Iadademstat, interventions name: Multigated Acquisition Scan, interventions name: Questionnaire Administration, interventions name: Venetoclax, outcomesModule primaryOutcomes measure: Incidence of dose-limiting toxicities (DLTs) within specific iadademstat (IADA) dose levels, secondaryOutcomes measure: Percentage of efficacy-evaluable participants achieving composite complete remission (cCR), secondaryOutcomes measure: Percentage of efficacy-evaluable participants achieving an overall response (ORR), secondaryOutcomes measure: Incidence of treatment-emergent grade ≥ 3 adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: OHSU Knight Cancer Institute, city: Portland, state: Oregon, zip: 97239, country: United States, contacts name: Curtis A. Lachowiez, role: CONTACT, phone: 503-494-5058, email: lachowie@ohsu.edu, contacts name: Curtis A. Lachowiez, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.52345, lon: -122.67621, hasResults: False