Study on Gilteritinib, Venetoclax, and Azacitidine for Newly Diagnosed Acute Myeloid Leukemia

Sponsor: Astellas Pharma Global Development, Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05520567

Provider View

This clinical trial is exploring a new combination of drugs—Gilteritinib, Venetoclax, and Azacitidine—for treating people newly diagnosed with acute myeloid leukemia (AML) who have a specific gene change and cannot undergo chemotherapy.

Patient Parameters

Program Overview

This study is testing a new treatment for people with acute myeloid leukemia (AML) who have a specific change in the FLT3 gene, which makes the cancer grow faster. The treatment combines three drugs: Gilteritinib, Venetoclax, and Azacitidine. It's for patients who can't have chemotherapy due to age or other health conditions. The study aims to find the right doses of these drugs, understand how they work together in the body, and check for any side effects. Participants will visit the clinic often for tests and monitoring. The study has two phases: Phase 1 will find the best dose of Venetoclax, and Phase 2 will test the treatment on more people. Participants can have up to 12 cycles of treatment, and those who respond well may continue with additional cycles. There will be follow-up visits to monitor health and treatment progress.

Eligibility Criteria

Exclusion Criteria

  • Have acute promyelocytic leukemia (APL) or active central nervous system involvement with AML.
  • Have a history of certain blood disorders or specific gene changes related to leukemia.
  • Have been treated with CAR-T cell therapy for AML or MDS, except for certain allowed treatments like hydroxyurea or leukapheresis.
  • Are receiving other experimental treatments or drugs that affect certain liver enzymes.
  • Have consumed grapefruit, Seville oranges, or starfruit within 3 days before starting the study.
  • Have severe heart conditions or a history of Long QT Syndrome.
  • Have another cancer diagnosed within the last 2 years, with some exceptions.
  • Have uncontrolled health issues like high blood pressure, infections, heart failure, or respiratory disease.
  • Have gastrointestinal issues affecting drug absorption.
  • Have active hepatitis B or C or other liver disorders.
  • Have had major surgery within 4 weeks before starting the study.
  • Have allergies to the study drugs.
  • Have a recent positive COVID-19 test without a follow-up negative result.
  • Require certain medications that interfere with the study drugs, except for specific antifungal treatments during the first phase.
  • Do not have specific FLT3 gene mutations.

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