RecruitingPhase 1Phase 2NCT06382168

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

Phase I/II Study of DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia

Sponsor

Delta-Fly Pharma, Inc.

Enrollment

39 participants

Start Date

Jun 12, 2024

Study Type

INTERVENTIONAL

Conditions

Leukemia, Myeloid, Acute

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests the combination of two drugs — DFP-10917 and venetoclax — for patients with acute myeloid leukemia (AML) that has come back or stopped responding to up to two prior treatments. Both drugs target cancer cell survival mechanisms in different ways. **You may be eligible if...** - You have confirmed AML that relapsed after, or did not respond to, up to two prior induction chemotherapy regimens - You are able to understand and follow the study requirements - You can provide informed consent **You may NOT be eligible if...** - You have had more than two prior induction treatment attempts - You have conditions that would make participation unsafe - You do not meet the specific relapse or refractory criteria defined by the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDFP-10917

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.

DRUGVenetoclax

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

Locations(4)

UCI Chao Family Comprehensive Cancer Center

Orange, California, United States

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

University of Vermont Cancer Center

Burlington, Vermont, United States

University of Virginia Cancer Center

Charlottesville, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT06382168

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