Study on DFP-10917 and Venetoclax for Treating Relapsed or Hard-to-Treat Acute Myeloid Leukemia

Sponsor: Delta-Fly Pharma, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06382168

Provider View

This clinical trial is testing a new treatment combination of DFP-10917 and venetoclax to see if it is safe and effective for patients with acute myeloid leukemia that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

This study is exploring a new treatment for acute myeloid leukemia (AML) that has come back or is not responding to other treatments. The treatment combines DFP-10917, given as a continuous IV infusion for 14 days, with venetoclax, taken orally for 14 days. The trial will first test the safety of this combination and then assess how well it works against leukemia. The study will involve up to 17 participants.

Description

This clinical trial is in two phases, Phase I and Phase II, to test a new treatment for acute myeloid leukemia (AML) that has returned or is not responding to other treatments. The treatment involves two drugs: DFP-10917, given through an IV for 14 days, and venetoclax, taken by mouth for 14 days. Each treatment cycle lasts 28 days.

In Phase I, the study will start with a low dose of DFP-10917 and venetoclax to check for any serious side effects. If the treatment is safe, more patients will be added to confirm its safety. If the treatment is well-tolerated, the study will move to Phase II to see how well it works against leukemia.

The study will use a specific design to determine the best dose and effectiveness of the treatment, with up to 17 patients expected to participate. The goal is to find a safe and effective dose that can help reduce leukemia in patients.

Eligibility Criteria

Inclusion Criteria

  • Must agree to participate and follow study requirements.
  • Have a confirmed diagnosis of acute myeloid leukemia (AML) that has returned or not responded to up to two previous treatments.
  • Have good organ function based on specific blood tests.
  • Be in good overall health with a performance status score of 0, 1, or 2.
  • Have a life expectancy of at least 12 weeks.
  • Women of childbearing age must have a negative pregnancy test and agree to use effective birth control during and for 3 months after treatment.
  • Men with female partners of childbearing age must agree to use effective birth control during and for at least 3 months after treatment.

Exclusion Criteria

  • Have significant side effects from previous chemotherapy.
  • Have a high number of leukemia cells in the blood.
  • Have a history of HIV or active hepatitis B or C infection.
  • Have another active cancer being treated.
  • Have active leukemia in the central nervous system unless controlled.
  • Have acute promyelocytic leukemia.
  • Have had recent cancer treatments or certain medications that cannot be stopped before the study.
  • Have had more than one previous treatment with venetoclax.
  • Have had a stem cell transplant.
  • Have conditions affecting digestion or absorption of medication.
  • Be pregnant or breastfeeding.
  • Have an uncontrolled infection.
  • Be taking certain medications that cannot be stopped before the study.

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