RECRUITING

DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase I/II Study of DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia

Quick Facts

Study Start:2024-06-12

Study Completion:2025-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06382168

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 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.	* 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.

Inclusion Criteria

Exclusion 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 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.

* 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.

Contacts and Locations

Study Contact

Scott Frank

CONTACT

+81 362311278

sfrank1206@delta-flypharma.co.jp

Study Locations (Sites)

UCI Chao Family Comprehensive Cancer Center

Orange, California, 92868

United States

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157

United States

University of Vermont Cancer Center

Burlington, Vermont, 05401

United States

University of Virginia Cancer Center

Charlottesville, Virginia, 22911

United States

Collaborators and Investigators

Sponsor: Delta-Fly Pharma, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-12

Study Completion Date2025-06-30

Study Record Updates

Study Start Date2024-06-12

Study Completion Date2025-06-30

Terms related to this study

Additional Relevant MeSH Terms

Leukemia, Myeloid, Acute