Study Comparing DFP-10917 with Other Treatments for Acute Myeloid Leukemia (AML) in Patients Needing Further Treatment

Sponsor: Delta-Fly Pharma, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03926624

Provider View

This clinical trial is testing a new drug, DFP-10917, against other standard treatments for patients with Acute Myeloid Leukemia (AML) who have not responded to previous therapies. The study aims to find out which treatment is more effective in achieving and maintaining remission.

Patient Parameters

Program Overview

This study is designed to compare the effectiveness of a new drug, DFP-10917, with other standard treatments for patients with Acute Myeloid Leukemia (AML) who have not responded to two, three, or four previous treatments. Patients will be randomly assigned to receive either DFP-10917 or one of the standard treatments, which may include less intensive or more intensive chemotherapy options, depending on their previous treatments and health condition.

Description

The trial aims to compare how well DFP-10917 works in achieving complete remission (CR) and how long the remission lasts in patients with AML who have not responded to previous treatments. Patients will be divided into two groups: one group will receive DFP-10917, and the other group will receive standard treatments, which could be less intensive or more intensive chemotherapy, based on their previous treatments and overall health.

In the experimental group, DFP-10917 will be given as a continuous infusion for 14 days, followed by a 14-day rest period, in 28-day cycles. If patients experience significant side effects, the dose may be reduced.

In the control group, patients will receive either non-intensive or intensive chemotherapy, depending on their previous treatments and health condition. Non-intensive options include drugs like LoDAC, Azacitidine, Decitabine, or Venetoclax combinations. Intensive options include high-dose Cytarabine or combinations like FLAG, MEC, or CLAG/M.

The choice of treatment in the control group will be based on the patient's previous treatments and health status, aiming to balance the treatment options between the two groups.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with AML that has returned or not responded after two to four previous treatments.
  • Aged 18 years or older.
  • In good general health with an ECOG performance status of 0, 1, or 2.
  • Have acceptable blood test results for kidney and liver function.
  • No active leukemia in the central nervous system.
  • No uncontrolled illnesses or infections.
  • Able to provide informed consent.
  • Women of childbearing potential must have a negative pregnancy test.
  • Agree to use effective birth control during the study and for at least one month after the last treatment.

Exclusion Criteria

  • Recent treatment with certain chemotherapy drugs within two weeks or other drugs within five half-lives.
  • Significant side effects from previous chemotherapy.
  • Poor heart function.
  • High white blood cell count.
  • Recent stem cell transplant or severe graft versus host disease.
  • Other serious health conditions that could affect the study.
  • Pregnant or breastfeeding women.
  • Other active cancers, except for certain controlled or treated types.
  • Acute promyelocytic leukemia (APL).
  • Known HIV, active hepatitis B or C infections, unless well-controlled.
  • Significant bleeding disorders.

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