Compares mesutoclax with venetoclax, both plus azacitidine, in untreated acute myeloid leukemia

Trial details

Who runs it

Beijing InnoCare Pharma Tech Co., Ltd.

Trial code

NCT07925190

Record updated

9 November 2026

Original description

A Phase III study comparing Mesutoclax + azacitidine versus venetoclax + azacitidine in newly diagnosed acute myeloid leukemia (AML) patientsRead full original descriptionShow less

A Randomized, Open-label, Multicenter Phase III Study of Mesutoclax Combined With Azacitidine Versus Venetoclax Combined With Azacitidine in the Treatment of Treatment Naive Acute Myeloid Leukemia (AML) Who Are Elderly or Ineligible for Intensive Chemotherapy

A Phase III study comparing Mesutoclax + azacitidine versus venetoclax + azacitidine in newly diagnosed acute myeloid leukemia (AML) patients

Inclusion: Study participants with newly diagnosed AML (excluding acute promyelocytic leukemia [APL]) confirmed per the 2022 World Health Organization (WHO) classification criteria; Age ≥65 years; or age ≥18 years and <65 years and ineligible for intensive chemotherapy; The participant is expected to have a survival time of at least 12 weeks; For participants aged ≥65 years: ECOG Performance Status (PS) 0-2; for participants aged ≥18 years and <65 years: ECOG PS 0-3; Participants must have adequate hepatic and renal function; Male participants must agree to refrain from unprotected sexual intercourse and sperm donation from the first dose of investigational product through 90 days after the last dose; Female participants must meet one of the following: postmenopausal; permanently sterilized; or, for females of reproductive potential, have a negative serum pregnancy test within 7 days prior to the first study dose. Females of reproductive potential must agree to use one highly effective contraceptive method plus a supplementary barrier contraceptive method with their partner from the date of ICF signature until 180 days after the last dose; The participant is able to communicate adequately with the investigator and comply with study procedures as specified in the protocol; The participant or their legally authorized representative voluntarily provides written informed consent.

Exclusion: Prior antitumor treatment for myeloid hematologic malignancies; Prior history of chronic myeloid leukemia (CML), myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN); Use of strong or moderate CYP3A/P-gp inhibitors or inducers (medications, dietary supplements, etc.) within 5 half-lives before the first dose of investigational product; Prior history of central nervous system disorders; Active hepatitis B virus or hepatitis C virus infection; History of immunodeficiency, including positive human immunodeficiency virus (HIV) antibody; Diagnosis of another active malignant neoplasm within the past 2 years; Severe active infection requiring intravenous antimicrobial therapy; History of severe cardiovascular disease; History of severe bleeding diathesis; Participants whom the investigator judges cannot adhere to the protocol due to uncontrolled medical, psychological, familial, social or geographic conditions; or participants who are unwilling or unable to follow protocol-required procedures; Malabsorption syndrome or other conditions that preclude oral administration or may interfere with drug absorption; Known hypersensitivity to the active ingredients/excipients of mesutoclax tablets, venetoclax, azacitidine, or mannitol; Peripheral blood white blood cell count >25×10\^9/L prior to randomization; Known central nervous system (CNS) involvement of leukemia; Known alcohol or substance dependence; Pregnant or breastfeeding female participants.

ClinicalTrials.gov NCT07925190