Study on Quizartinib, Decitabine, and Venetoclax for Treating Untreated or Returning Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03661307

Provider View

This clinical trial is testing a combination of three drugs—Quizartinib, Decitabine, and Venetoclax—to see if they can effectively treat patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) that is either newly diagnosed or has returned after treatment.

Patient Parameters

Program Overview

This study is exploring how well a combination of three drugs—Quizartinib, Decitabine, and Venetoclax—works in treating patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) that is either untreated or has come back. Quizartinib may help stop cancer cells from growing by blocking certain enzymes. Decitabine and Venetoclax are chemotherapy drugs that work in different ways to stop cancer cells from growing, dividing, or spreading. The study aims to find out if using these drugs together is more effective in treating AML and MDS.

Description

The main goals of this study are to determine how well the combination of Quizartinib, Decitabine, and Venetoclax works in achieving remission in patients with newly diagnosed or relapsed AML or high-risk MDS within three months of starting treatment. The study will also assess the safety and the highest dose that can be tolerated.

Secondary goals include evaluating the duration of response, survival rates, and the number of patients who can proceed to stem cell transplant. Researchers will also look at genetic factors that might influence how patients respond to the treatment.

The study is divided into two phases: Phase I will focus on finding the safest dose, and Phase II will evaluate the effectiveness of the treatment. Patients will receive Decitabine through an IV for 10 days, Quizartinib orally every day starting from the first day, and Venetoclax orally for 14 to 21 days. Treatment cycles repeat every 28 days unless the disease progresses or side effects become unacceptable.

After completing the treatment, patients will have follow-up visits every 3 to 6 months for up to 5 years to monitor their health and the long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) with more than 10% blasts.
  • For newly diagnosed patients: Must be 60 years or older and not suitable for intensive chemotherapy.
  • For relapsed patients: Must be 18 years or older and not eligible for curative treatments like stem cell transplant.
  • Must have a specific genetic mutation (FLT3-ITD) detected within 30 days before joining the study.
  • Must not have received chemotherapy for AML or MDS before, except for certain temporary treatments.
  • Must be able to take oral medication and provide informed consent.
  • Must have adequate heart function and normal blood test results.
  • Women of childbearing potential must have a negative pregnancy test and use effective contraception during the study.

Exclusion Criteria

  • Known allergy to any of the study drugs.
  • Previous use of Quizartinib.
  • Uncontrolled central nervous system leukemia.
  • Electrolyte imbalances that cannot be corrected.
  • Significant gastrointestinal issues that affect drug absorption.
  • Severe or uncontrolled medical conditions that could interfere with the study.
  • Active infections like HIV or hepatitis B/C unless under control.
  • Recent major surgery or consumption of certain fruits that affect drug metabolism.
  • Heart conditions that affect rhythm or function.
  • Use of medications that affect heart rhythm or interact with study drugs.

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