DFP-10917 for Acute Myeloid Leukemia

Recruiting at 37 trial locations

Overseen By Tapan Kadia, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Delta-Fly Pharma, Inc.

Disqualifiers: Cardiac dysfunction, High WBC, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 28-day cycles

450 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

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.

Research Team

Tapan Kadia, MD

Principal Investigator

M.D. Anderson Cancer Center

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

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

Treatment Details

Interventions

• DFP-10917

Trial Overview 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.

Participant Groups

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

Who Is Running the Clinical Trial?

Delta-Fly Pharma, Inc.

Lead Sponsor

Trials

5

Recruited

610+

Findings from Research

In a study of 46 acute myeloid leukemia (AML) patients, a combination of Chinese medicine and chemotherapy significantly improved blood counts and immune cell levels after 2 months of treatment, indicating enhanced recovery post-remission.

The treatment led to a maximum disease-free survival (DFS) of 123 months, with a 3-year survival rate of 64.15% and a 5-year survival rate of 51.19%, suggesting that this integrative approach may be effective for long-term management of AML.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Observation on treatment of post-remission acute myeloid leukemia patients by lingxiong piaoling powder and longchan cigu decoction]. Su, EY., Chen, HS., Han, YM.[2017]

Older patients with acute myeloid leukemia (AML) have a lower success rate with standard chemotherapy compared to younger patients, highlighting a need for tailored treatment approaches.

The review emphasizes that age-related changes in drug metabolism and toxicity can significantly impact the efficacy of antileukemic agents, suggesting that modifications to current therapies may improve outcomes for elderly patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An extensive pharmacokinetic, metabolic and toxicological review of elderly patients under intensive chemotherapy for acute myeloid leukemia. Kaur, I., Constance, JE., Kosak, KM., et al.[2017]

The traditional classification of acute myeloid leukemia (AML) is inadequate for predicting treatment outcomes and does not account for significant subgroups, such as elderly patients or those with AML following myelodysplastic syndrome (MDS).

A new classification model divides AML into MDS-related (MDR-AML) and true de novo (TDN-AML) groups, which have distinct genetic characteristics and treatment responses, suggesting that this revised model could improve therapeutic strategies and outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Revised classification of acute myeloid leukemia. Head, DR.[2013]

Acute myelogenous leukemia (AML) is more prevalent in older adults, and traditional chemotherapy may not be suitable for them due to various biological factors, highlighting the need for tailored treatments.

Promising new treatment options for older AML patients include CPX-351, a liposomal formulation of cytarabine and daunorubicin, and other therapies like alvocidib, clofarabine, tipifarnib, decitabine, and azacitidine, which are being evaluated for their efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of therapeutic agents for older patients with acute myelogenous leukemia. Hourigan, CS., Karp, JE.[2021]

In a study of 100 patients with acute myeloid leukaemia not responsive to first induction chemotherapy (PIF-AML), the overall survival (OS) rates were low, with only 23% alive after a median follow-up of 11 months, highlighting the poor prognosis of this condition.

Allogeneic stem cell transplantation (Allo-SCT) significantly improved the 12-month OS probability to 60% compared to 35% for those who did not undergo the procedure, emphasizing the critical need for urgent donor searches and effective pre-transplant treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicentre survey to explore current survival of patients with acute myeloid leukaemia who failed induction chemotherapy. Lazzarotto, D., Candoni, A., Nadali, G., et al.[2017]

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]

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]

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

Revised classification of acute myeloid leukemia. [2013]

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

Development of therapeutic agents for older patients with acute myelogenous leukemia. [2021]

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

Multicentre survey to explore current survival of patients with acute myeloid leukaemia who failed induction chemotherapy. [2017]