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Anti-tumor antibiotic

DFP-10917 + Venetoclax for Acute Myeloid Leukemia

Phase 1 & 2
Recruiting
Research Sponsored by Delta-Fly Pharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group performance status of 0, 1, or 2
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, epigenetic therapy, or targeted therapy
Must not have
Known active central nervous system involvement by leukemia
Malabsorption syndrome or other condition that precludes enteral route of administration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

"This trial is testing a new drug, DFP-10917, in combination with venetoclax for patients with relapsed or refractory acute myeloid leukemia. The trial involves giving D

Who is the study for?
This trial is for adults with Acute Myeloid Leukemia that has come back or didn't respond to previous treatments. Participants must be able to handle continuous IV infusions and oral medications, and have acceptable organ function.
What is being tested?
The study tests DFP-10917 given as a continuous IV infusion over 14 days combined with an oral course of venetoclax in patients. The safety and initial effectiveness are evaluated, starting at specific doses which may increase if safe.
What are the potential side effects?
Possible side effects include reactions related to the IV infusion, gastrointestinal issues from the oral medication, potential impact on blood cell counts leading to increased infection risk, fatigue, and liver function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and perform daily activities.
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My acute myeloid leukemia has returned or didn't respond after up to 2 treatments.
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My organ functions are within normal ranges according to recent tests.
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I am not pregnant and agree to use birth control.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My leukemia has spread to my brain or spinal cord.
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I cannot take medications by mouth due to a digestive condition.
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I have a history of HIV or active hepatitis B/C.
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I do not have an active, uncontrolled infection.
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I have lasting side effects from past chemotherapy that are noticeable but not severe.
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I have been diagnosed with acute promyelocytic leukemia.
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I have had a stem cell transplant before.
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I am currently receiving treatment for another cancer.
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I have been treated with Venetoclax in more than one treatment plan.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: DFP-10917 + Venetoclax for 14 daysExperimental Treatment2 Interventions
DFP-10917 4 mg/m\^2/day with venetoclax 400 mg once daily for 14 days
Group II: DFP-10917 + Venetoclax for 10 daysExperimental Treatment2 Interventions
DFP-10917 4 mg/m\^2/day with venetoclax 400 mg once daily for 10 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DFP-10917
2012
Completed Phase 2
~70
Venetoclax
2019
Completed Phase 3
~2240

Find a Location

Who is running the clinical trial?

Delta-Fly Pharma, Inc.Lead Sponsor
4 Previous Clinical Trials
572 Total Patients Enrolled
~17 spots leftby Mar 2025
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