drugset / Trial / NCT06382168
DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-06-12
- Primary completion
- 2026-03-31
- Completion
- 2026-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DFP-10917 | Unknown | 4 mg/m2 | Intravenous |
| Subject | Venetoclax | Small molecule | 400 mg | Oral |