Study on the Combination of Ivosidenib, Azacitidine, and Venetoclax Followed by Ivosidenib Alone for Treating Acute Myeloid Leukemia

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60

ClinicalTrials ID:NCT07392242

This clinical trial is exploring a new treatment approach for people with newly diagnosed acute myeloid leukemia (AML) that has a specific IDH mutation. The study will test a combination of three drugs—ivosidenib, azacitidine, and venetoclax—followed by maintenance therapy with ivosidenib alone to see if it effectively treats AML and prevents it from returning.

Patient Parameters

Program Overview

The purpose of this study is to determine if a combination of three drugs—ivosidenib, azacitidine, and venetoclax—followed by ongoing treatment with ivosidenib alone, is an effective way to treat people with newly diagnosed acute myeloid leukemia (AML) that has a specific IDH mutation. The study will also assess the safety of this treatment and the time commitment required for participants.

Eligibility Criteria

Inclusion Criteria

  • Must be at least 60 years old.
  • Willing and able to follow the study schedule and requirements.
  • Have a new diagnosis of acute myeloid leukemia (AML) according to specific medical guidelines.
  • Have an IDH1-R132 mutation confirmed by specific genetic tests.
  • Have a performance status score between 0 and 3, indicating varying levels of activity.
  • White blood cell count must be below 25,000/μL before starting the study treatment.
  • Have adequate organ function, including liver and kidney function, as determined by specific blood tests.

Exclusion Criteria

  • Have acute promyelocytic leukemia.
  • Have previously received ivosidenib or venetoclax.
  • Are receiving other experimental cancer treatments, except for certain allowed therapies.
  • Have severe, life-threatening complications from leukemia.
  • Have an active, uncontrolled infection despite treatment.
  • Are planned for a stem cell transplant based on doctor's assessment.
  • Have significant heart disease within the last 6 months.
  • Have active infections with HIV, hepatitis B, or hepatitis C without improvement.
  • Have conditions that affect the ability to swallow or absorb oral medications.
  • Have a heart condition that affects the QT interval on an ECG.
  • Are not willing to follow contraceptive guidelines during the study.

Locations

FACILITYZIPCITYSTATE
Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)07920Basking RidgeNew Jersey
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)07748MiddletownNew Jersey
Memorial Sloan Kettering Bergen (Limited Protocol Activities)07645MontvaleNew Jersey
Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)11725CommackNew York
Memorial Sloan Kettering Westchester (Limited Protocol Activities)10604HarrisonNew York
Memorial Sloan Kettering Cancer Center (All Protocol Activities)10065New YorkNew York
Memorial Sloan Kettering Nassau (Limited Protocol Activites)11553Rockville CentreNew York

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