Vyxeos for Re-induction Treatment of Acute Myeloid Leukemia Patients With Persistent Disease After Initial Treatment

Sponsor: Ohio State University Comprehensive Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04049539

Provider View

This study is testing the safety and effectiveness of Vyxeos, a combination of chemotherapy drugs, for patients with acute myeloid leukemia (AML) who did not respond to their first round of standard chemotherapy.

Patient Parameters

Program Overview

This phase II clinical trial is exploring how well Vyxeos, a combination of the chemotherapy drugs cytarabine and daunorubicin, works in patients with intermediate and high-risk acute myeloid leukemia (AML) who did not respond to their initial treatment. Vyxeos is designed to deliver these drugs in a way that may reduce side effects and improve effectiveness compared to when the drugs are given separately. The study aims to see if Vyxeos can help control the growth of cancer cells by killing them, stopping them from dividing, or preventing them from spreading.

Description

Primary Objectives:

  • To assess the safety and effectiveness of Vyxeos, a liposome-encapsulated combination of daunorubicin and cytarabine, in patients with acute myeloid leukemia (AML) who did not achieve a reduction in bone marrow cells after initial treatment.

Secondary and Exploratory Objectives:

  • To determine the rate at which patients achieve a state free of visible leukemia cells.
  • To evaluate how long patients live without the disease worsening and their overall survival over two years.
  • To measure how well Vyxeos clears out dormant leukemia stem cells and active cancer cells compared to previous treatments.
  • To compare the effectiveness of Vyxeos in eliminating cancer cells with other standard treatments.

Study Outline:

Patients will receive Vyxeos intravenously over 90 minutes on days 1 and 3, within 14-33 days after their last chemotherapy cycle, as long as the disease does not progress or cause unacceptable side effects. After treatment, patients will be monitored weekly for 60 days, then at least monthly for two years.

Eligibility Criteria

Inclusion Criteria

  • Must be able to provide written informed consent.
  • Diagnosed with acute myeloid leukemia (AML).
  • Previously received standard chemotherapy with cytarabine and daunorubicin within 14-33 days before starting the trial and have persistent disease.
  • Must be unlikely to achieve complete response without further therapy.
  • Must be able to tolerate intensive chemotherapy.
  • Normal heart function and a lifetime daunorubicin dose of less than 418 mg/m².
  • ECOG performance status of 0, 1, or 2.
  • Liver and kidney function within specified limits.
  • Female patients must use two forms of contraception and have a negative pregnancy test.
  • Male patients must agree to use contraception or abstain from intercourse and refrain from sperm donation during and after treatment.

Exclusion Criteria

  • Have acute promyelocytic leukemia or specific genetic types of AML.
  • Have certain genetic mutations or chromosomal abnormalities.
  • Unable to tolerate intensive chemotherapy.
  • History of severe allergic reactions to study drugs.
  • Known copper metabolism disorders.
  • Total lifetime daunorubicin dose exceeding 418 mg/m².
  • Pregnant or unable to use effective contraception.
  • Uncontrolled infections.
  • Recent use of investigational drugs.
  • Factors that prevent understanding or following the study protocol.
  • Significant medical conditions that could interfere with the study.
  • Uncontrolled heart conditions or recent heart attack.
  • Other active cancers requiring treatment.

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