nctId: NCT06382168 id: D19-11186 briefTitle: Phase I/II Study of DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2025-03-31 date: 2025-06-30 date: 2024-04-24 date: 2024-04-24 name: Delta-Fly Pharma, Inc. class: INDUSTRY 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. conditions: Leukemia, Myeloid, Acute studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 39 type: ESTIMATED name: DFP-10917 name: Venetoclax measure: Number of patients with dose-limiting toxicities assessed by CTCAE v5.0. measure: Number of patients with treatment-related adverse events assessed by CTCAE v5.0. 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). measure: The proportion of patients who achieve complete remission. measure: The proportion of patients who achieve complete remission or complete remission with incomplete hematologic recovery. measure: The proportion of patients achieving complete remission or complete remission with incomplete hematologic recovery, and morphologic leukemia-free state. measure: Overall survival. measure: Progression-free survival. measure: Maximum concentration of DFP-10917. measure: Area under the curve of DFP-10917. measure: Volume of distribution of DFP-10917. measure: Clearance of DFP-10917. measure: Time to maximum concentration of venetoclax. measure: Maximum concentration of venetoclax. measure: Elimination half-life of venetoclax. measure: Area under the curve of venetoclax. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UCI Chao Family Comprehensive Cancer Center city: Orange state: California zip: 92868 country: United States name: Kiran Naqvi role: PRINCIPAL_INVESTIGATOR lat: 33.78779 lon: -117.85311 facility: Atrium Health Wake Forest Baptist Comprehensive Cancer Center city: Winston-Salem state: North Carolina zip: 27157 country: United States name: Timothy Pardee role: PRINCIPAL_INVESTIGATOR lat: 36.09986 lon: -80.24422 facility: Simmons Cancer Center: UT Southwestern city: Dallas state: Texas zip: 75235 country: United States lat: 32.78306 lon: -96.80667 facility: University of Vermont Cancer Center city: Burlington state: Vermont zip: 05401 country: United States name: Diego Adrianzen Herrer role: PRINCIPAL_INVESTIGATOR lat: 44.47588 lon: -73.21207 facility: University of Virginia Cancer Center city: Charlottesville state: Virginia zip: 22911 country: United States name: Michael Keng role: PRINCIPAL_INVESTIGATOR lat: 38.02931 lon: -78.47668 hasResults: False