DFP-10917 with Venetoclax for Relapsed or Refractory AML
This study is testing a new combination treatment for acute myeloid leukemia (AML) that has come back or hasn't responded to previous treatments. It combines two drugs, DFP-10917 and venetoclax. DFP-10917 is given as a continuous infusion into a vein for 14 days, followed by a 14-day break. Venetoclax is taken by mouth for 10-14 days, also followed by a 14-day break. Researchers want to find the safest dose of DFP-10917 when given with venetoclax and see how well this combination works against leukemia. This study is currently recruiting up to 39 adult participants.
- Study design
- This is a Phase I/II, open-label study, meaning both you and your doctors will know which treatments you are receiving. It plans to enroll up to 39 participants.
- What's involved
- DFP-10917 is given as a 14-day continuous intravenous (IV) infusion, and venetoclax is taken by mouth for 10-14 days, both followed by a 14-day rest period in each 28-day cycle.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety will be assessed from the first day of treatment until 30 days after treatment completion.
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NCT06382168
DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia
Recruiting
PHASE1Ages 18+InterventionalTreatmentDelta-Fly Pharma, Inc.
~39 participants
Updated 2025-09-03 on ClinicalTrials.gov
What's tested:DFP-10917Venetoclax
At a glance
Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of patients with dose-limiting toxicities assessed by CTCAE v5.0.
Measured over From the first day of treatment start until 30 days after treatment completion.
+2 more outcomes measured
Conditions
Where it's being run
4 sites across 4 statesCalifornia1
North Carolina1
Vermont1
Virginia1
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Signed informed consent and ability to comply with protocol requirements.
Histologically or pathologically confirmed diagnosis of acute myeloid leukemia based on World Health Organization classification that has relapsed after, or is refractory to, up to 2 prior induction regimens that may have included intensive chemotherapy (e.g., "7+3" cytarabine and daunorubicin), epigenetic therapy (i.e., azacitidine or decitabine with/without venetoclax), or targeted therapy (e.g., FLT-3, IDH 1/2, BCL-2, monoclonal antibody).
Adequate organ function as defined by the following laboratory values:
Creatinine clearance \>30 mL/min (by Cockcroft-Gault method),
Total serum bilirubin \<1.5 × upper limit of normal unless due to Gilbert's syndrome, leukemic organ involvement, hemolysis or considered an effect of regular blood transfusions,
Alanine aminotransferase and aspartate aminotransferase \<3 × upper limit of normal, unless due to leukemic organ involvement.
Eastern Cooperative Oncology Group performance status of 0, 1, or 2).
Projected life expectancy of ≥12 weeks.
Female patients of childbearing potential must:
Have a negative serum or urine pregnancy test prior to study treatment initiation.
Agree to use at least 1 highly effective form of contraception during study treatment and for 3 months after the last dose.
Male patients with female partners of childbearing potential must -- Agree to use at least 1 highly effective form of contraception during study treatment and for at least 3 months after the last dose.
Exclusion
Any \>Grade 1 persistent clinically significant toxicities from prior chemotherapy.
Leukemic blast count \>25 × 109/L. Hydroxyurea permitted to control leukocytosis.
Known history of human immunodeficiency virus or active hepatitis B or active hepatitis C infection.
Concomitant malignancies for which patients are receiving active therapy at the time of signing consent. Patients with adequately treated basal or squamous cell carcinoma of the skin, adequately treated carcinoma in situ (e.g., cervix), breast cancer receiving adjuvant endocrine therapy or prostate cancer not under active systemic treatment other than hormonal therapy may enroll irrespective of the time of diagnosis, with Medical Monitor approval.
Known active central nervous system involvement by leukemia. Patients with previously diagnosed central nervous system leukemia are eligible if the central nervous system leukemia is under control and intrathecal treatment may continue throughout the study.
Diagnosis of acute promyelocytic leukemia.
Prior exposure to anticancer therapies including chemotherapy, radiotherapy or other investigational therapy, including targeted small molecule agents within 14 days of the first day of study treatment or within 5 half-lives prior to first dose of study treatment. Note that hydroxyurea up to 5 g daily × 3 days is permitted to reduce elevated white blood cell (WBC) count.
Venetoclax exposure in more than 1 prior regimen.
Prior exposure to biologic agents (e.g., monoclonal antibodies) for anti-neoplastic intent within 14 days prior to first dose of study drug.
Prior hematopoietic stem cell transplantation.
Malabsorption syndrome or other condition that precludes enteral route of administration.
Pregnancy or lactation.
Active uncontrolled systemic infection (viral, bacterial, or fungal).
Ongoing treatment with strong or moderate CYP3A inhibitors or CYP3A inducers, P-gp inhibitors, or narrow therapeutic index P-gp substrates that cannot be discontinued at least 1 week prior to start of venetoclax dosing excluding antifungal prophylaxis.
What this trial measures
- Number of patients with dose-limiting toxicities assessed by CTCAE v5.0.From the first day of treatment start until 30 days after treatment completion.
- Number of patients with treatment-related adverse events assessed by CTCAE v5.0.The first 28 days of study treatment (Cycle 1).
- Recommended Phase 2 dose of DFP-10917 in combination with venetoclax (the dose at which <2 out of 6 patients experience a dose-limiting toxicity during the safety assessment period).The first 28 days of study treatment (Cycle 1).