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New hope for Tough-to-Treat leukemia: experimental drug DFP-10917 tested in Late-Stage trial

NCT ID NCT03926624

Disease control Sponsor: Delta-Fly Pharma, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug called DFP-10917 in adults with acute myeloid leukemia (AML) that had returned or not responded after 2 to 4 prior treatments. Participants received either DFP-10917 or one of several standard chemotherapy combinations. The goal was to see if DFP-10917 could achieve complete remission (no signs of cancer) and how long that remission might last. The trial was terminated early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

167 people

The number who actually took part.

Started

Nov 2019

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histologically or pathologically confirmed diagnosis of AML based on WHO classification that has relapsed after, or is refractory to, two, three, or four prior induction regimens that may have included intensive chemotherapy (e.g., "7+3" cytarabine and daunorubicin), epigenetic therapy (i.e., azacitidine or decitabine), 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 after first CR or CR without complete platelet recovery (CRp). Refractory AML is defined as persistent disease ≥28 days after initiation of intensive induction therapy (up to two induction cycles) or relapse \<90 days after first CR or CRp. 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.) Patients with a history of IPSS-R high or very high risk MDS that transformed to AML during treatment with hypomethylating drugs and then relapse following or are refractory to a subsequent AML induction regimen may be enrolled as Second Salvage AML patients. Additionally, patients with a history of MPN in accelerated phase (MPN-AP) or high-risk primary myelofibrosis (PMF) that transformed to AML during treatment with hypomethylating drugs and then relapse following or are refractory to a subsequent AML induction regimen may be enrolled as Second Salvage AML patients. 2. Aged ≥ 18 years. 3. ECOG Performance Status of 0, 1 or 2. 4. Adequate clinical laboratory values (i.e., plasma creatinine \<2.5 x upper limit of normal (ULN) for the institution, bilirubin \<2.5 x ULN, alanine transaminase (ALT) and aspartate transaminase (AST) ≤2.5 x ULN). 5. Absence of active central nervous system (CNS) involvement by leukemia. Patients with previously diagnosed CNS leukemia are eligible if the CNS leukemia is under control and intrathecal treatment may continue throughout the study. 6. Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, or other organ dysfunctions. 7. Signed informed consent prior to the start of any study specific procedures. 8. Women of child-bearing potential must have a negative serum or urine pregnancy test. 9. Male and female patients must agree to use acceptable contraceptive methods for the duration of the study and for at least one month after the last drug administration. Exclusion Criteria: 1. The interval from prior treatment to time of study drug administration is \< 2 weeks for cytotoxic agents or \< 5 half-lives for noncytotoxic agents. Exceptions: Use of hydroxyurea is allowed before the start of study and is to be discontinued prior to the initiation of study treatment. At the investigator's discretion, for patients with significant leukocytosis that develops during the early treatment cycles, hydroxyurea may be administered. The hydroxyurea should be discontinued as soon as clinically appropriate. 2. Any \>grade 1 persistent clinically significant toxicities from prior chemotherapy. 3. Inadequate Cardiac (left ventricular ejection fraction ≤40%) function. 4. White blood cell (WBC) count \>15,000/μL (Note: Patients considered for possible venetoclax-containing regimen must have WBC ≤10k/μL prior to initiating venetoclax treatment). 5. For patients with prior hematopoietic stem cell transplant (HSCT): 1. Less than 3 months since HSCT 2. Acute Graft versus Host Disease (GvHD) \>Grade 1 3. Chronic GvHD \>Grade 1 6. Any concomitant condition that in the opinion of the investigator could compromise the objectives of this study and the patient's compliance. 7. A pregnant or lactating woman. 8. Current malignancies of another type. Exceptions: Patients may participate if they have previously treated and currently controlled prostate cancer, or adequately treated in situ cervical cancer or basal cell skin cancer, or other malignancies with no evidence of disease for 2 years or more. 9. Patient has acute promyelocytic leukemia (APL). 10. Patients with known HIV, active HBV or active HCV infection (note: testing for these infections is not required). For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. 11. Documented or known clinically significant bleeding disorder.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Leukemia, myeloid, acute

Contacts and locations

Locations

  • AdventHealth Medical Group Blood and Marrow Transplant at Orlando

    Orlando, Florida, 32804, United States

  • Avera Medical Group

    Sioux Falls, South Dakota, 57105, United States

  • Banner MD Anderson

    Gilbert, Arizona, 85234, United States

  • Baptist MD Anderson

    Jacksonville, Florida, 32207, United States

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Decatur Memorial Hospital-Cancer Care Specialists of Central IL

    Decatur, Illinois, 62526, United States

  • East Carolina University

    Greenville, North Carolina, 27834, United States

  • Franciscan Health Indianapolis

    Indianapolis, Indiana, 46237, United States

  • Gabrail Cancer Center

    Canton, Ohio, 44718, United States

  • Georgia Cancer Center at Augusta University

    Augusta, Georgia, 30912, United States

  • Henry Ford Cancer Institute

    Detroit, Michigan, 48202, United States

  • HonorHealth (VGPCC Cancer Transplant Institute)

    Scottsdale, Arizona, 85258, United States

  • Loyola University Medical Center

    Hines, Illinois, 60153, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Multicare Institute for Research and Innovation

    Spokane, Washington, 99218, United States

  • New York Medical College

    Valhalla, New York, 10595, United States

  • Norton Cancer Institute

    Louisville, Kentucky, 40241, United States

  • Novant Health Cancer Institute - Elizabeth (Hematology)

    Charlotte, North Carolina, 28204, United States

  • Novant Health Cancer Institute - Forsyth (Hematology)

    Winston-Salem, North Carolina, 27103, United States

  • O'Neal Comprehensive Cancer Center

    Birmingham, Alabama, 35294, United States

  • Ochsner Benson Cancer Center

    Jefferson, Louisiana, 70121, United States

  • Prisma Health Cancer Institute

    Greenville, South Carolina, 29605, United States

  • Rush University

    Chicago, Illinois, 60612, United States

  • Seidman Cancer Center, University Hospitals, Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • The University of Arizona Cancer Center

    Tucson, Arizona, 85724-5024, United States

  • The University of Kansas Cancer Center

    Westwood, Kansas, 66205, United States

  • The University of Mississippi Medical Center

    Jackson, Mississippi, 39216, United States

  • Tulane University

    New Orleans, Louisiana, 70118, United States

  • UCLA

    Los Angeles, California, 90095, United States

  • UF-Health Cancer Center Gainesville

    Gainesville, Florida, 32608, United States

  • UF-Health Jacksonville

    Jacksonville, Florida, 32209, United States

  • UT Southwestern

    Dallas, Texas, 75390, United States

  • University of California

    Irvine, California, 92697, United States

  • University of Cincinnati Cancer Center

    Cincinnati, Ohio, 45267, United States

  • University of KY- Markey Cancer Center

    Lexington, Kentucky, 40536, United States

  • University of Vermont Medical Center

    Burlington, Vermont, 05401, United States

  • University of Virginia Health System

    Charlottesville, Virginia, 22903, United States

  • Vidant Oncology

    Kinston, North Carolina, 28501, United States

  • Wake Forest Baptist Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157, United States

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Other studies related to the condition(s) this trial covers.