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

Part of paid clinical trials in Orange, California.

Sponsor
Delta-Fly Pharma, Inc.
Study ID
NCT06382168
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Leukemia, Myeloid, Acute

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DFP-10917 — DRUG
    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.
  • Venetoclax — DRUG
    Venetoclax 400 mg once daily for 10-14 days, followed by a 14-day rest in each 28-day cycle.

Study Details

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.

Key Dates

Start date
Jun 12, 2024
Status verified
Sep 2024
Primary completion
Mar 31, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
39 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: DFP-10917 + Venetoclax for 14 days
    DFP-10917 4 mg/m\^2/day with venetoclax 400 mg once daily for 14 days
  • Experimental: DFP-10917 + Venetoclax for 10 days
    DFP-10917 4 mg/m\^2/day with venetoclax 400 mg once daily for 10 days

Primary Outcome Measure

Number of patients with dose-limiting toxicities assessed by CTCAE v5.0. [ Time Frame: From the first day of treatment start until 30 days after treatment completion. ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
UCI Chao Family Comprehensive Cancer CenterOrangeCalifornia92868
Kiran Naqvi, MD, MPH
[email protected]
714-456-8000
Kiran Naqvi, MD, MPH (PRINCIPAL_INVESTIGATOR)
Atrium Health Wake Forest Baptist Comprehensive Cancer CenterWinston-SalemNorth Carolina27157
Timothy Pardee, MD
[email protected]
336-716-5847
Timothy Pardee (PRINCIPAL_INVESTIGATOR)
University of Vermont Cancer CenterBurlingtonVermont05401
Diego Adrianzen Herrera, MD
[email protected]
802-656-2021
Diego Adrianzen Herrer (PRINCIPAL_INVESTIGATOR)
University of Virginia Cancer CenterCharlottesvilleVirginia22911
Michael Keng, MD
[email protected]
434-424-1505
Michael Keng (PRINCIPAL_INVESTIGATOR)

Find similar trials in Orange, CA

By research site
UCI Chao Family Comprehensive Cancer Center· Orange, CAAtrium Health Wake Forest Baptist Comprehensive Cancer Center· Winston-Salem, NCUniversity of Vermont Cancer Center· Burlington, VTUniversity of Virginia Cancer Center· Charlottesville, VA

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