protocolSection identificationModule nctId: NCT06382168, orgStudyIdInfo id: D19-11186, briefTitle: Phase I/II Study of DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-31, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Delta-Fly Pharma, Inc., class: INDUSTRY, descriptionModule briefSummary: This Phase I/II trial evaluates the safety and preliminary efficacy of DFP-10917 combined with venetoclax in relapsed or refractory acute myeloid leukemia. DFP-10917 is given as a 14-day continuous IV infusion every 28 days, alongside a 14-day oral course of venetoclax following an initial dose ramp-up. The initial phase tests a starting dose of 4 mg/m²/day of DFP-10917 with 400 mg daily of venetoclax. The Data Monitoring Committee reviews toxicity after one treatment cycle. If DLTs are minimal, more patients are added to confirm safety. If the lower dose level shows tolerability, it proceeds to the Phase II expansion to assess the treatment's effectiveness against leukemia using a Simon's two-stage design, targeting up to 17 participants., conditionsModule conditions: Leukemia, Myeloid, Acute, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 39, type: ESTIMATED, armsInterventionsModule interventions name: DFP-10917, interventions name: Venetoclax, outcomesModule primaryOutcomes measure: Number of patients with dose-limiting toxicities assessed by CTCAE v5.0., primaryOutcomes measure: Number of patients with treatment-related adverse events assessed by CTCAE v5.0., primaryOutcomes measure: Recommended Phase 2 dose of DFP-10917 in combination with venetoclax (the dose at which <2 out of 6 patients experience a dose-limiting toxicity during the safety assessment period)., secondaryOutcomes measure: The proportion of patients who achieve complete remission., secondaryOutcomes measure: The proportion of patients who achieve complete remission or complete remission with incomplete hematologic recovery., secondaryOutcomes measure: The proportion of patients achieving complete remission or complete remission with incomplete hematologic recovery, and morphologic leukemia-free state., secondaryOutcomes measure: Overall survival., secondaryOutcomes measure: Progression-free survival., secondaryOutcomes measure: Maximum concentration of DFP-10917., secondaryOutcomes measure: Area under the curve of DFP-10917., otherOutcomes measure: Volume of distribution of DFP-10917., otherOutcomes measure: Clearance of DFP-10917., otherOutcomes measure: Time to maximum concentration of venetoclax., otherOutcomes measure: Maximum concentration of venetoclax., otherOutcomes measure: Elimination half-life of venetoclax., otherOutcomes measure: Area under the curve of venetoclax., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UCI Chao Family Comprehensive Cancer Center, city: Orange, state: California, zip: 92868, country: United States, contacts name: Kiran Naqvi, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.78779, lon: -117.85311, locations facility: Atrium Health Wake Forest Baptist Comprehensive Cancer Center, city: Winston-Salem, state: North Carolina, zip: 27157, country: United States, contacts name: Timothy Pardee, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.09986, lon: -80.24422, locations facility: Simmons Cancer Center: UT Southwestern, city: Dallas, state: Texas, zip: 75235, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: University of Vermont Cancer Center, city: Burlington, state: Vermont, zip: 05401, country: United States, contacts name: Diego Adrianzen Herrer, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.47588, lon: -73.21207, locations facility: University of Virginia Cancer Center, city: Charlottesville, state: Virginia, zip: 22911, country: United States, contacts name: Michael Keng, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.02931, lon: -78.47668, hasResults: False