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NCT06382168 · ClinicalTrials.gov registry record · Phase 1
DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia
A Phase 1 study of Leukemia, Myeloid, Acute, sponsored by Delta-Fly Pharma.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
- 4
- Study locations
NCT06382168 is a Phase 1 study of Leukemia, Myeloid, Acute that is actively recruiting participants, run by Delta-Fly Pharma. The registered enrollment target is 39 participants, below the 115-participant average among 30 other Leukemia, Myeloid, Acute trials with a reported enrollment target (66% lower). The trial reports 4 study locations across 4 states.
The verdict
NCT06382168, a Phase 1 study of Leukemia, Myeloid, Acute, is actively recruiting participants, sponsored by Delta-Fly Pharma.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
- 4
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG DFP-10917
Study Locations (4)
California
- UCI Chao Family Comprehensive Cancer Center - Orange
North Carolina
- Atrium Health Wake Forest Baptist Comprehensive Cancer Center - Winston-Salem
Vermont
- University of Vermont Cancer Center - Burlington
Virginia
- University of Virginia Cancer Center - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2024-06-12 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06382168
The ClinicalTrials.gov registry entry for NCT06382168 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 115-participant average among 30 other Leukemia, Myeloid, Acute trials with a reported enrollment target (66% lower). The listed sponsor is Delta-Fly Pharma, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Leukemia, Myeloid, Acute appearing as the primary indexed condition, and to 2 interventions - of which Venetoclax is the first listed.
NCT06382168 reports 4 study locations spanning 4 distinct geographic areas - top geographies include California, North Carolina, Vermont.
Frequently Asked Questions
What is clinical trial NCT06382168 about?
NCT06382168 is a clinical study titled "DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia". 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...
What is the current status of trial NCT06382168?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2024-06-12. Estimated completion is 2026-06-30.
What conditions does trial NCT06382168 study?
This clinical trial studies the following conditions: Leukemia, Myeloid, Acute.
What interventions are being tested in trial NCT06382168?
The interventions under investigation include: Venetoclax (DRUG), DFP-10917 (DRUG).
Who is sponsoring clinical trial NCT06382168?
This trial is sponsored by Delta-Fly Pharma, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06382168 being conducted?
This trial has 4 study locations across California, North Carolina, Vermont, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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