Study on Venetoclax and HMA Treatment for Older Adults with FLT3 Mutated Acute Myeloid Leukemia (AML)

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06317649

Provider View

This clinical trial is comparing the usual treatment of azacitidine and venetoclax with a new combination that includes azacitidine, venetoclax, and gilteritinib for older adults with acute myeloid leukemia (AML) that has a specific FLT3 mutation. The study aims to find out if the new combination is more effective in achieving deeper remission.

Patient Parameters

Program Overview

This study is testing whether adding the drug gilteritinib to the usual treatment of azacitidine and venetoclax can improve outcomes for older adults with acute myeloid leukemia (AML) that has a specific FLT3 mutation. Azacitidine helps activate genes that control cell growth, venetoclax blocks a protein needed for cancer cell survival, and gilteritinib blocks a substance that helps cancer cells multiply. The study will compare the effectiveness of these treatments in achieving remission and will also assess their safety and tolerability.

Description

The study has several goals:

  • Primary Goal: To see if the new combination of azacitidine, venetoclax, and gilteritinib can achieve a complete remission without detectable disease better than azacitidine and venetoclax alone.

  • Secondary Goals: To evaluate the safety of the new combination and determine the best way to use gilteritinib with the other drugs. The study will also look at overall survival rates and how long patients remain free of disease.

  • Exploratory Goals: To examine how the FLT3 mutation changes during treatment and if these changes affect remission duration. The study will also monitor other mutations that might influence treatment response.

Participants will be randomly assigned to one of three treatment groups:

  • Group 1: Receives azacitidine and venetoclax.
  • Group 2: Receives azacitidine, venetoclax, and gilteritinib.
  • Group 3: Receives azacitidine, venetoclax, and gilteritinib in a different schedule.

All participants will have regular bone marrow and blood tests to monitor their response to treatment. After completing the study treatment, participants will have follow-up visits every few months to check their health and cancer status.

Eligibility Criteria

Inclusion Criteria

  • Must be 60 years or older, or younger adults who are not suitable for intensive chemotherapy.
  • Must have a confirmed diagnosis of AML, excluding certain subtypes.
  • Must not have received prior treatment for AML, except for specific exceptions like hydroxyurea.
  • Must have a specific FLT3 mutation.
  • Must not be pregnant or breastfeeding and must agree to use effective contraception.
  • Must be able to understand and sign a consent form.
  • Must have adequate liver and kidney function.
  • Must not have a prolonged QT interval on an ECG.
  • Must not have active or uncontrolled infections.
  • Must not require ongoing treatment with certain medications that could interfere with the study.
  • Must not have other health conditions that could affect the study outcomes.

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