Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia
NCT06382168 · View on ClinicalTrials.gov ↗
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?
Always speak with your doctor before enrolling in a clinical 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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Delta-Fly Pharma, which has 33 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06382168 reports 4 study locations spanning 4 distinct geographic areas — top geographies include California, North Carolina, Vermont. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06382168?
The interventions under investigation include: Venetoclax (DRUG), DFP-10917 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06382168?
This trial is sponsored by Delta-Fly Pharma, which has 33 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.