Actively Recruiting
Phase I/II Study of DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia
Led by Delta-Fly Pharma, Inc. · Updated on 2025-09-03
39
Participants Needed
4
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and early effectiveness of combining DFP-10917 and venetoclax in patients with relapsed or refractory acute myeloid leukemia (AML). This Phase I/II open-label trial aims to find the right dose and assess how well this combination works against leukemia. The study focuses on patients whose AML has returned or not responded after previous treatments. The safety of the treatment is monitored closely, especially for dose-related toxicities. The treatment involves giving DFP-10917 as a continuous intravenous infusion for 14 days every 28-day cycle. Venetoclax is taken orally for 14 days following a dose ramp-up at the start. Initially, patients receive 4 mg/m²/day of DFP-10917 with 400 mg of venetoclax daily. The study evaluates this dose level for safety and adjusts treatment duration if needed. Once a safe dose is confirmed, the trial expands to assess how well the treatment controls leukemia in more patients. Participants will be closely monitored during treatment cycles with assessments of side effects and blood levels of the drugs. Researchers measure dose-limiting toxicities, treatment-related adverse events, and response to therapy, including remission rates and survival outcomes over time. The study includes regular evaluations during treatment cycles and long-term follow-up to understand treatment effects and patient outcomes.
CONDITIONS
Brief Title
DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and able to follow study requirements
- Diagnosed with acute myeloid leukemia that has relapsed or is refractory after up to 2 prior induction treatments
- Adequate organ function including creatinine clearance above 30 mL/min and liver enzymes within specified limits
- Eastern Cooperative Oncology Group performance status of 0, 1, or 2
- Projected life expectancy of at least 12 weeks
- Female participants of childbearing potential must have a negative pregnancy test and agree to use effective contraception
- Male participants with female partners of childbearing potential must agree to use effective contraception
You will not qualify if you...
- Persistent significant toxicities greater than Grade 1 from prior chemotherapy
- Leukemic blast count above 25 x 10^9/L
- Known HIV infection or active hepatitis B or C infection
- Active other cancers receiving therapy, except certain treated skin and in situ cancers with approval
- Active central nervous system involvement by leukemia unless controlled
- Diagnosis of acute promyelocytic leukemia
- Recent anticancer therapies within 14 days or 5 half-lives before study treatment
- More than one prior regimen of venetoclax exposure
- Prior biologic anti-cancer agents within 14 days before study drug
- Prior hematopoietic stem cell transplant
- Conditions preventing oral drug intake
- Pregnancy or breastfeeding
- Active uncontrolled infections
- Ongoing use of certain medications affecting venetoclax metabolism that cannot be stopped at least one week before dosing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive DFP-10917 as a 14-day continuous intravenous infusion and venetoclax orally daily for 10 to 14 days, followed by a 14-day rest period in each 28-day cycle. This combination treatment is repeated in cycles to assess safety and efficacy.
Visits occur during each 28-day cycle according to treatment administration and safety assessments
Duration - Up to 100 months from start of treatment
Participants are monitored for treatment-related adverse events and disease status after completing treatment cycles.
Periodic visits for ongoing assessments and survival follow-up
Trial Site Locations
Total: 4 locations
1
UCI Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
2
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
3
University of Vermont Cancer Center
Burlington, Vermont, United States, 05401
Actively Recruiting
4
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22911
Actively Recruiting
Research Team
S
Scott Frank
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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