DFP-10917 for Acute Myeloid Leukemia

Recruiting in Palo Alto (17 mi)

+37 other locations

Overseen by Tapan Kadia, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Delta-Fly Pharma, Inc.

Disqualifiers: Cardiac dysfunction, High WBC, HIV, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

Phase III, multicenter, randomized study with two arms (1:1 ratio) enrolling patients with AML relapsed/refractory after 2, 3, or 4 prior induction regimens: Experimental arm: DFP-10917 14-day continuous intravenous (IV) infusion at a dose of 6 mg/m²/day followed by a 14-day resting period per 28-day cycles. Control arm: Non-Intensive Reinduction (LoDAC, Azacitidine, Decitabine, Venetoclax Combination Regimens) or Intensive Reinduction (High and Intermediate Dose Cytarabine Regimens), depending on the patient's prior induction treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, there is a requirement to wait at least 2 weeks after cytotoxic treatments or 5 half-lives for noncytotoxic treatments before starting the study drug. Hydroxyurea is allowed before and during early treatment cycles if needed.

What makes the drug DFP-10917 unique for treating acute myeloid leukemia?

The drug DFP-10917 is unique for treating acute myeloid leukemia because it represents a novel approach compared to traditional chemotherapy, which often involves cytarabine and anthracyclines. While specific details about DFP-10917's mechanism or administration are not provided, its development suggests an effort to address the limitations of existing treatments, especially for patients who do not respond well to standard therapies.

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Eligibility Criteria

This trial is for adults over 18 with AML that's come back or hasn't responded after 2-4 previous treatments. They should be relatively healthy (ECOG Performance Status of 0, 1, or 2) and have good kidney, liver, and blood test results. People with active leukemia in the brain or uncontrolled illnesses can't join.

Inclusion Criteria

I do not have any uncontrolled illnesses.

Adequate clinical laboratory values

Signed informed consent prior to the start of any study specific procedures

Exclusion Criteria

My heart's pumping ability is reduced (LVEF ≤40%).

White blood cell (WBC) count >15,000/μL

Any concomitant condition that in the opinion of the investigator could compromise the objectives of this study and the patient's compliance

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either DFP-10917 or a control regimen (Non-Intensive or Intensive Reinduction) based on prior treatments and clinical condition

28-day cycles

Continuous monitoring during treatment cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Participant Groups

The study compares DFP-10917 given as a continuous IV infusion for two weeks followed by two weeks off against standard reinduction therapies chosen based on what patients had before. It's a phase III trial where participants are randomly assigned to one of these treatments.

Group I: Experimental Experimental Treatment 1 Intervention

DFP-10917 Dose: 6 mg/m²/day administered by continuous infusion for 14 days followed by a 14-day resting period per 28-day treatment cycle. If a patient experiences a significant treatment-related AE, the patient may undergo one dose reduction of DFP-10917 to 4 mg/m²/day x 14 days for subsequent treatment cycles

Group II: Control Active Control 9 Interventions

Non-Intensive: * LoDAC: 20 mg SC BID 10 days * Azacitidine: 75 mg/m²/day SC 7 days(or 5+2) * Decitabine: CIV 20 mg/m²x5 days * Venetoclax + LoDAC/Azacitidine/Decitabine:LoDAC-Venetoclax ramp-up to 600 mgxday. Cytarabine SC 20 mg/m²xday D1-10. Azacitidine or Decitabine-Venetoclax ramp-up to 400 mgxday. Azacitidine IV or SC 75 mg/m² D1-7. Decitabine IV 20 mg/m² on D1-5 or 1-10. Intensive: * High DAC: cytarabine 1-2 g/m² up to 5 days, max total dose 10 g/m² * FLAG: D1-5: fludarabine 30 mg/m² IV for 30min, D1-5: cytarabine 1-2 g/m² for 4hr daily x 5 \& G-CSF 5 mcg/kg or 300 mcg/m² until PMN recovery, with or without idarubicin D1-3 8 mg/m² IV dailyx3 (FLAG-Ida) * MEC: D1-6: mitoxantrone 6 mg/m² IV bolus, etoposide 80 mg/m² IV 1hr \& cytarabine 1g/m² IV 6hr. * CLAG/M or Ida = cladribine 5 mg/m² D1-5, cytarabine 2 g/m² D1-5, G-CSF 300 μg D0-5, mitoxantrone 10 mg/m² D1-3 or Idarubicin 10 mg/m² D1-3. * Intermediate DAC: cytarabine 20 mg/m² IV dailyx5

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

The University of Kansas Cancer Center Westwood, KS

Henry Ford Cancer Institute Detroit, MI

Gabrail Cancer Center Canton, OH

Novant Health Cancer Institute - Elizabeth (Hematology) Charlotte, NC

More Trial Locations

Who Is Running the Clinical Trial?

Delta-Fly Pharma, Inc. Lead Sponsor

References

1. China pubmed.ncbi.nlm.nih.gov

[Observation on treatment of post-remission acute myeloid leukemia patients by lingxiong piaoling powder and longchan cigu decoction]. [2017] To explore the effect of the treatment for long-term disease-free survival (DFS) of post-remission patients with acute myeloid leukemia (AML).

2. England pubmed.ncbi.nlm.nih.gov

An extensive pharmacokinetic, metabolic and toxicological review of elderly patients under intensive chemotherapy for acute myeloid leukemia. [2017] Acute myeloid leukemia (AML) is a clonal hematological malignancy characterized by accumulation of poorly differentiated and immature blast cells in bone marrow and blood circulation. The initiation of intensive chemotherapy is necessary to control further progression of the disease. Therapeutic success is less common in older patients (> 65 years) than it is in younger patients with AML. Cytarabine in combination with an anthracycline has been the mainstays of AML therapy for many years and continues to serve as the foundation for the current standard therapeutic regimen.

3. England pubmed.ncbi.nlm.nih.gov

Revised classification of acute myeloid leukemia. [2013] The traditional classification and model of acute myeloid leukemia (AML), in common usage for much of the twentieth century, correlates poorly with treatment outcome, biologic studies, and genetic markers in AML, fails to accommodate large subgroups such as typical AML in the elderly or AML following myelodysplastic syndrome (MDS), and (except for acute promyelocytic leukemia) is not used in clinical decisions. Available data suggest an alternative classification and model that initially divides AML into two groups not recognized by traditional classification: MDS-related (MDR)-AML and true de novo (TDN)-AML. MDR-AML includes most AML in the elderly, AML following MDS, AML complicating Fanconi's anemia, and a minor subset of AML in children; these subgroups appear to be linked by a common mutator phenotype, common genetic abnormalities, multilineage hematopoietic dysplasia, clonal hematopoiesis, and poor outcome with cytotoxic chemotherapy. TDN-AML includes AML with the common translocations seen in children and young adults; these subgroups lack features of a mutator phenotype, have approximately flat incidence throughout life, have similar genetic abnormalities, lack multilineage hematopoietic dysplasia and clonal hematopoiesis, and often have good outcome with cytotoxic chemotherapy. Progression in TDN-AML appears to consist predominantly of expansion of a transformed clone, while progression in MDR disease appears to consist initially of progressive accumulation of genetic damage, eventuating in malignant transformation to MDR-AML in some cases. This revised model and classification create therapeutically significant disease groups, allow rapprochement of clinical, morphologic, genetic, and biologic findings in AML, provide a rational model for AML, and frame questions that provide logical direction for future diagnostic, therapeutic, and biologic studies in AML.

4. England pubmed.ncbi.nlm.nih.gov

Development of therapeutic agents for older patients with acute myelogenous leukemia. [2021] Acute myelogenous leukemia (AML) is a disease more common in older patients than in the young. It is increasingly recognized that conventional cytotoxic chemotherapies used in children and young adults may not be appropriate in older adults because of diverse host- and disease-biology factors. This review highlights some of the most promising new treatment options that are being evaluated for older patients with AML. These options include CPX-351 (Celator Pharmaceuticals Inc), a unique liposomal formulation of a fixed ratio of cytarabine and daunorubicin; timed sequential therapy with the CDK inhibitor alvocidib (flavopiridol; sanofi-aventis/NCI); the second-generation purine nucleoside analog clofarabine; the farnesyltransferase inhibitor tipifarnib (Johnson & Johnson Pharmaceutical Research and Development LLC); and the DNA methyltransferase inhibitors decitabine and azacitidine.

5. England pubmed.ncbi.nlm.nih.gov

Multicentre survey to explore current survival of patients with acute myeloid leukaemia who failed induction chemotherapy. [2017] Acute myeloid leukaemia not responsive to first induction chemotherapy (PIF-AML) still remains a challenge, and there are only few recent epidemiological data regarding the outcome of these patients. In this multicentre survey, we evaluate the prognosis and outcome of patients with PIF-AML, who were diagnosed and treated in the last 5 yrs in four Italian institutions.