Leukemia, Myeloid, AcutePhase 1/2NCT06382168
DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia
A Phase 1/2 study testing DFP-10917 and Venetoclax in people with Leukemia, Myeloid, Acute, run by Delta-Fly Pharma, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myeloid, Acute
- What is being tested?
- DFP-10917 and Venetoclax
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 4 sitesUnited States
- Study dates
- 12 Jun 2024to 30 Jun 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- (Relapse is defined as reemergence of ≥5% leukemia blasts in bone marrow or ≥1% blasts in peripheral blood 90 days to 24 months after first complete remission or complete remission with incomplete hematologic recovery. Refractory acute myeloid leukemia is defined as persistent disease ≥28 days after initiation of intensive induction therapy (up to 2 induction cycles) or relapse <90 days after first complete remission or complete remission with incomplete hematologic recover. Refractory disease for patients undergoing hypomethylating agent induction is defined as lack of remission following at least 2 cycles of epigenetic therapy without reduction in bone marrow blast status).
- 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,
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
University of Vermont Cancer Center
Burlington, Vermont, 05401
Diego Adrianzen Herrera, MD, 802-656-2021, dadrianz@med.uvm.edu
Diego Adrianzen Herrer
- Recruiting
University of Virginia Cancer Center
Charlottesville, Virginia, 22911
Michael Keng, MD, 434-424-1505, mk2pv@uvahealth.org
Michael Keng
- Recruiting
UCI Chao Family Comprehensive Cancer Center
Orange, California, 92868
Kiran Naqvi, MD, MPH, 714-456-8000, knaqvi1@hs.uci.edu
Kiran Naqvi, MD, MPH
- Recruiting
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
Timothy Pardee, MD, 336-716-5847, tspardee@wakehealth.edu
Timothy Pardee
About this study
Official title: Phase I/II Study of DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia
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.
Read the detailed description
This study is a Phase I/II, open-label trial exploring dosage and expansion cohorts to assess the safety and preliminary efficacy of DFP-10917 in combination with venetoclax for patients with relapsed or refractory acute myeloid leukemia (AML). DFP-10917 will be administered as a 14-day continuous intravenous infusion starting on Day 1, followed by a 14-day rest period, during each 28-day cycle. This will occur concurrently with venetoclax, administered orally at a dose of 400 mg daily for 14 days following a dose ramp-up phase (100 mg and 200 mg on Day 1 and 2, respectively).
In Phase I, the starting dose for DFP-10917 is 4 mg/m²/day, administered concurrently with 400 mg of venetoclax once daily for 14 days (Dose Level 1). The Data Monitoring Committee (DMC) will assess dose-limiting toxicities (DLTs) after three patients are enrolled at this dose level and the last patient has completed the 4-week safety assessment period (i.e., one cycle of the combination regimen). At Dose Level 1 (4 mg/m²/day of DFP-10917 with venetoclax 400 mg daily for 14 days), if none of the three patients experience a DLT, the study will enroll an additional three patients at this dose level to confirm the combination's safety and tolerability. If one out of three patients experiences a DLT, up to three additional patients may be enrolled. If one or fewer out of six treated patients experience a DLT at Dose Level 1, this dose will be declared the recommended Phase II dose (RP2D) and used in the Phase II expansion cohort. If two or more patients out of the total three to six patients at Dose Level 1 experience a DLT, the study will continue enrollment at Dose Level 1 (4 mg/m²/day of DFP-10917 for 14 days concurrently with venetoclax 400 mg daily for 10 days of each 28-day cycle) to determine the safety and tolerability of Dose Level -1. A patient who discontinues therapy during Cycle 1 without experiencing DLTs is considered evaluable for safety purposes only if all scheduled doses of DFP-10917 and at least 80% of the venetoclax doses were administered in the first cycle. Once the RP2D of DFP-10917 in combination with venetoclax is determined, the expansion cohort will begin enrollment to evaluate the anti-leukemia efficacy of this combination. A Simon's two-stage min-max design will be employed, with up to 17 patients expected to participate.
- Conditions
- Leukemia, Myeloid, Acute
- Being tested
- DFP-10917, Venetoclax
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFP-10917Drug
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.
VenetoclaxDrug
Venetoclax 400 mg once daily for 10-14 days, followed by a 14-day rest in each 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| DFP-10917 + Venetoclax for 14 days | Experimental | DFP-10917 4 mg/m^2/day with venetoclax 400 mg once daily for 14 days Receives: Drug: DFP-10917; Drug: Venetoclax |
| DFP-10917 + Venetoclax for 10 days | Experimental | DFP-10917 4 mg/m^2/day with venetoclax 400 mg once daily for 10 days Receives: Drug: DFP-10917; Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with dose-limiting toxicities assessed by CTCAE v5.0.
Measured: 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.
Measured: 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).
Measured: The first 28 days of study treatment (Cycle 1).
Secondary outcomes (7)
The proportion of patients who achieve complete remission.
Measured: From the start of the study treatment to the first documented progression or death from any cause, whichever occurs first, assessed for up to 100 months.
The proportion of patients who achieve complete remission or complete remission with incomplete hematologic recovery.
Measured: From the start of the study treatment to the first documented progression or death from any cause, whichever occurs first, assessed for up to 100 months.
The proportion of patients achieving complete remission or complete remission with incomplete hematologic recovery, and morphologic leukemia-free state.
Measured: From the start of the study treatment to the first documented progression or death from any cause, whichever occurs first, assessed for up to 100 months.
Overall survival.
Measured: From the start of the study treatment to death from any cause, whichever occurs first, assessed for up to 100 months.
Progression-free survival.
Measured: From the start of the study treatment to the first documented progression or death from any cause, whichever occurs first, assessed for up to 100 months.
Maximum concentration of DFP-10917.
Measured: The first 15 days of study treatment.
Area under the curve of DFP-10917.
Measured: The first 15 days of study treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start12 Jun 2024
- Primary completion31 Mar 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myeloid, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Delta-Fly Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382168
- Sponsor's protocol ID
- D19-11186
- Status last verified
- Sep 2024
- First submitted
- 19 Apr 2024
- Last updated
- 3 Sep 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT06382168
- Acronym / sponsor ID
- D19-11186
- Conditions
- Leukemia, Myeloid, Acute
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Delta-Fly Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a Phase I/II, open-label trial exploring dosage and expansion cohorts to assess the safety and preliminary efficacy of DFP-10917 in combination with venetoclax for patients with relapsed or refractory acute myeloid leukemia (AML). DFP-10917 will be administered as a 14-day continuous intravenous infusion starting on Day 1, followed by a 14-day rest period, during each 28-day cycle. This will occur concurrently with venetoclax, administered orally at a dose of 400 mg daily for 14 days following a dose ramp-up phase (100 mg and 200 mg on Day 1 and 2, respectively).
In Phase I, the starting dose for DFP-10917 is 4 mg/m²/day, administered concurrently with 400 mg of venetoclax once daily for 14 days (Dose Level 1). The Data Monitoring Committee (DMC) will assess dose-limiting toxicities (DLTs) after three patients are enrolled at this dose level and the last patient has completed the 4-week safety assessment period (i.e., one cycle of the combination regimen). At Dose Level 1 (4 mg/m²/day of DFP-10917 with venetoclax 400 mg daily for 14 days), if none of the three patients experience a DLT, the study will enroll an additional three patients at this dose level to confirm the combination's safety and tolerability. If one out of three patients experiences a DLT, up to three additional patients may be enrolled. If one or fewer out of six treated patients experience a DLT at Dose Level 1, this dose will be declared the recommended Phase II dose (RP2D) and used in the Phase II expansion cohort. If two or more patients out of the total three to six patients at Dose Level 1 experience a DLT, the study will continue enrollment at Dose Level 1 (4 mg/m²/day of DFP-10917 for 14 days concurrently with venetoclax 400 mg daily for 10 days of each 28-day cycle) to determine the safety and tolerability of Dose Level -1. A patient who discontinues therapy during Cycle 1 without experiencing DLTs is considered evaluable for safety purposes only if all scheduled doses of DFP-10917 and at least 80% of the venetoclax doses were administered in the first cycle. Once the RP2D of DFP-10917 in combination with venetoclax is determined, the expansion cohort will begin enrollment to evaluate the anti-leukemia efficacy of this combination. A Simon's two-stage min-max design will be employed, with up to 17 patients expected to participate.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DFP-10917 + Venetoclax for 14 days | Experimental | Drug: DFP-10917, Drug: VenetoclaxDFP-10917 4 mg/m^2/day with venetoclax 400 mg once daily for 14 days |
| DFP-10917 + Venetoclax for 10 days | Experimental | Drug: DFP-10917, Drug: VenetoclaxDFP-10917 4 mg/m^2/day with venetoclax 400 mg once daily for 10 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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).
- (Relapse is defined as reemergence of ≥5% leukemia blasts in bone marrow or ≥1% blasts in peripheral blood 90 days to 24 months after first complete remission or complete remission with incomplete hematologic recovery. Refractory acute myeloid leukemia is defined as persistent disease ≥28 days after initiation of intensive induction therapy (up to 2 induction cycles) or relapse <90 days after first complete remission or complete remission with incomplete hematologic recover. Refractory disease for patients undergoing hypomethylating agent induction is defined as lack of remission following at least 2 cycles of epigenetic therapy without reduction in bone marrow blast status).
- Adequate organ function as defined by the following laboratory values:
- Eastern Cooperative Oncology Group performance status of 0, 1, or 2).
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DFP-10917DFP-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. | Drug | DFP-10917 + Venetoclax for 10 days, DFP-10917 + Venetoclax for 14 days |
| VenetoclaxVenetoclax 400 mg once daily for 10-14 days, followed by a 14-day rest in each 28-day cycle. | Drug | DFP-10917 + Venetoclax for 10 days, DFP-10917 + Venetoclax for 14 days |
Primary outcome
Number of patients with dose-limiting toxicities assessed by CTCAE v5.0.
Time frame: 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.
Time frame: 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).
Time frame: The first 28 days of study treatment (Cycle 1).
7 secondary outcomes
The proportion of patients who achieve complete remission.
Time frame: From the start of the study treatment to the first documented progression or death from any cause, whichever occurs first, assessed for up to 100 months.
The proportion of patients who achieve complete remission or complete remission with incomplete hematologic recovery.
Time frame: From the start of the study treatment to the first documented progression or death from any cause, whichever occurs first, assessed for up to 100 months.
The proportion of patients achieving complete remission or complete remission with incomplete hematologic recovery, and morphologic leukemia-free state.
Time frame: From the start of the study treatment to the first documented progression or death from any cause, whichever occurs first, assessed for up to 100 months.
Overall survival.
Time frame: From the start of the study treatment to death from any cause, whichever occurs first, assessed for up to 100 months.
Progression-free survival.
Time frame: From the start of the study treatment to the first documented progression or death from any cause, whichever occurs first, assessed for up to 100 months.
Maximum concentration of DFP-10917.
Time frame: The first 15 days of study treatment.
Area under the curve of DFP-10917.
Time frame: The first 15 days of study treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DFP-10917 and Venetoclax in people with Leukemia, Myeloid, Acute, run by Delta-Fly Pharma, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Scott Frank (+81 362311278, sfrank1206@delta-flypharma.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with dose-limiting toxicities assessed by CTCAE v5.0. (time frame: From the first day of treatment start until 30 days after treatment completion.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.