Study on Bleximenib with Standard Chemotherapy for Treating Acute Myeloid Leukemia (AML)

Sponsor: Stichting Hemato-Oncologie voor Volwassenen Nederland

Sponsor score: 0

ClinicalTrials ID:NCT07223814

Provider View

This clinical trial is testing whether adding the drug Bleximenib to standard chemotherapy can improve treatment outcomes for adults with newly diagnosed Acute Myeloid Leukemia (AML) that have specific genetic mutations.

Patient Parameters

Program Overview

The study aims to find out if Bleximenib, when combined with standard chemotherapy, can help treat adults with Acute Myeloid Leukemia (AML) who have specific genetic changes in their leukemia cells. Bleximenib works by blocking a protein interaction that helps leukemia cells survive. This trial is randomized and double-blind, meaning neither the participants nor the doctors know who is receiving Bleximenib or a placebo, which is a look-alike pill with no active ingredients. The trial will include 875 adults who have not been treated for AML before and have specific DNA changes in their leukemia cells. Participants will be followed for four years after treatment to compare results between different groups.

Eligibility Criteria

Inclusion Criteria

  • Be 18 years or older.
  • Newly diagnosed with Acute Myeloid Leukemia (AML) with specific genetic mutations (NPM1 or KMT2A).
  • Eligible for intensive chemotherapy.
  • Have a performance status score of 2 or lower, indicating good overall health.
  • Have adequate kidney and liver function before starting the study.

Exclusion Criteria

  • Have received any prior treatment for AML.
  • Have active leukemia in the central nervous system.
  • Have had a solid organ transplant.
  • Have certain heart conditions, such as recent heart attack, unstable chest pain, severe heart failure, or abnormal heart rhythms.
  • Have a prolonged QT interval on an ECG (QTcF greater than or equal to 470 milliseconds).
  • Have a heart's left ventricle pumping ability of less than 40%.
  • Have received high doses of certain chemotherapy drugs in the past.
  • Have chronic lung disease requiring extra oxygen.

Locations

FACILITYZIPCITYSTATE
US-Cincinnati OH-CINCY45219CincinnatiOhio

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