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New treatment option for Leukemia, Myeloid, Acute
Official title DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT06382168
What this study is testing
What is DFP-10917?
DFP-10917 is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for leukemia, myeloid, acute.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- Known active central nervous system involvement by leukemia. Patients with previously diagnosed central nervous system leukemia are eligible if the...
- Diagnosis of acute promyelocytic leukemia.
See the full eligibility criteria
- 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...
- 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.
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
- Winston-Salem, North Carolina, United States
- Burlington, Vermont, United States
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States; Winston-Salem, North Carolina, United States; Burlington, Vermont, United States; Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.