DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia

StatusUnknown
PhasePhase 1/2
Started

Record status This record was last updated September 3, 2025 (before its estimated March 31, 2026 completion). Its status may not reflect the trial's current state.

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Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Primary completion date: Mar 31, 2025 to Mar 31, 2026
    • Study completion date: Jun 30, 2025 to Jun 30, 2026
    v4
  3. Site contacts updated at 4 of 4 sitesv3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 5 to 4
    • Start date changed from estimate of May 31, 2024 to Jun 12, 2024
    • Study title shortened, about 4 words
    v2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06382168
Lead Sponsor Delta-Fly Pharma, Inc.
Conditions
(from sponsor)		 Leukemia, Myeloid, Acute
Related terms Leukemia, Myeloid, Acute
Enrollment 39 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov