Phase I/II Study of DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia
Delta-Fly Pharma, Inc.
Summary
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.
Description
This study is a Phase I/II, open-label trial exploring dosage and expansion cohorts to assess the safety and preliminary efficacy of DFP-10917 in combination with venetoclax for patients with relapsed or refractory acute myeloid leukemia (AML). DFP-10917 will be administered as a 14-day continuous intravenous infusion starting on Day 1, followed by a 14-day rest period, during each 28-day cycle. This will occur concurrently with venetoclax, administered orally at a dose of 400 mg daily for 14 days following a dose ramp-up phase (100 mg and 200 mg on Day 1 and 2, respectively). In Phase I, the…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Signed informed consent and ability to comply with protocol requirements. * Histologically or pathologically confirmed diagnosis of acute myeloid leukemia based on World Health Organization classification that has relapsed after, or is refractory to, up to 2 prior induction regimens that may have included intensive chemotherapy (e.g., "7+3" cytarabine and daunorubicin), epigenetic therapy (i.e., azacitidine or decitabine with/without venetoclax), or targeted therapy (e.g., FLT-3, IDH 1/2, BCL-2, monoclonal antibody). (Relapse is defined as reemergence of ≥5% leukemia bl…
Interventions
- DrugDFP-10917
DFP-10917 4 mg/m\^2/day is given as a continuous 14-day intravenous infusion, followed by a 14-day rest in each 28-day cycle.
- DrugVenetoclax
Venetoclax 400 mg once daily for 10-14 days, followed by a 14-day rest in each 28-day cycle.
Locations (4)
- UCI Chao Family Comprehensive Cancer CenterOrange, California
- Atrium Health Wake Forest Baptist Comprehensive Cancer CenterWinston-Salem, North Carolina
- University of Vermont Cancer CenterBurlington, Vermont
- University of Virginia Cancer CenterCharlottesville, Virginia