Study on Bleximenib, Venetoclax, and Azacitidine for Treating Newly Diagnosed Acute Myeloid Leukemia (AML)

Sponsor: Janssen Research & Development, LLC

Sponsor score: 60

ClinicalTrials ID:NCT06852222

This clinical trial is testing a new combination of drugs, Bleximenib, Venetoclax, and Azacitidine, to see if they work better than the current standard treatment for patients with newly diagnosed Acute Myeloid Leukemia (AML) that has specific genetic mutations.

Patient Parameters

Program Overview

The aim of this study is to find out if a new combination of drugs—Bleximenib, Venetoclax, and Azacitidine—can be more effective than the usual treatment for patients who have just been diagnosed with Acute Myeloid Leukemia (AML) and have certain genetic changes in their cancer cells.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have newly diagnosed Acute Myeloid Leukemia (AML) with specific genetic changes (KMT2Ar or NPM1m) and at least 10% cancer cells in the bone marrow.
  • Not eligible for intensive chemotherapy due to age (75 or older) or other health issues like heart, lung, kidney, or liver problems.
  • Must have good liver and kidney function.
  • Women must agree not to become pregnant or breastfeed during the study and for 6 months after the last treatment.
  • Men must agree to use contraception during the study and for at least 90 days after the last treatment.
  • Must be willing to sign a consent form to participate in the study.

Exclusion Criteria

  • Have a type of leukemia called acute promyelocytic leukemia (APL).
  • Have leukemia that has spread to the brain or spinal cord.
  • Have had a solid organ transplant.
  • Have serious heart problems like a recent heart attack or unstable chest pain.
  • Have active hepatitis infection.
  • Have received a live vaccine within 4 weeks before starting the study.
  • Have known allergies to any of the study drugs.

Locations

FACILITYZIPCITYSTATE
Cancer Treatment Center of America Phoenix85338GoodyearArizona
University of Arkansas at Little Rock72204Little RockArkansas
City of Hope91010DuarteCalifornia
Orlando Health Cancer Institute32806OrlandoFlorida
Moffit Cancer center33612TampaFlorida
Cleveland Clinic Florida33331WestonFlorida
University of Chicago Medicine60637ChicagoIllinois
University of Kentucky Markey Cancer Center40536LexingtonKentucky
Norton Cancer Institute40207LouisvilleKentucky
Mary Bird Perkins Cancer Center70809Baton RougeLouisiana

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