Actively Recruiting
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
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 ability to comply with protocol requirements.
- Diagnosis of acute myeloid leukemia that has relapsed after or is refractory to up to 2 prior induction regimens.
- Adequate organ function: creatinine clearance >30 mL/min; total serum bilirubin <1.5 times upper limit of normal except in specific conditions; alanine aminotransferase and aspartate aminotransferase <3 times upper limit of normal unless due to leukemic involvement.
- Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
- Projected life expectancy of at least 12 weeks.
- Female patients of childbearing potential must have a negative pregnancy test before treatment and agree to use effective contraception during treatment and for 3 months after last dose.
- Male patients with female partners of childbearing potential must agree to use effective contraception during treatment and for at least 3 months after last dose.
You will not qualify if you...
- Persistent clinically significant toxicities greater than Grade 1 from prior chemotherapy.
- Leukemic blast count greater than 25 x 10^9/L (hydroxyurea allowed to control).
- Known HIV infection or active hepatitis B or C infection.
- Active malignancies being treated at consent, except certain treated skin or in situ cancers with approval.
- Active central nervous system leukemia involvement unless controlled and intrathecal treatment ongoing.
- Diagnosis of acute promyelocytic leukemia.
- Recent exposure to chemotherapy, radiotherapy, investigational therapies, or biologic agents within specified timeframes.
- More than one prior regimen of venetoclax exposure.
- Prior hematopoietic stem cell transplantation.
- Conditions preventing oral medication intake.
- Pregnancy or breastfeeding.
- Active uncontrolled infections.
- Current treatment with certain CYP3A or P-gp interacting drugs that cannot be stopped before venetoclax dosing except antifungal prophylaxis.
AI-Screening
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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
CONTACT
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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