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NCT07925190

A Study Comparing Mesutoclax + Azacitidine Versus Venetoclax + Azacitidine in Untreated Acute Myeloid Leukemia (AML) Patients

StatusRecruiting
PhasePhase 3
Primary completion (estimated)
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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

  1. Recruitment opened Show 4 more changesShow less
    • Start date changed from estimate of Nov 2026 to Nov 3, 2026
    • Primary endpoint revised
    • Study site revised
    • Study title shortened, about 2 words
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Overall Survival (OS)
Timeframe: through the study completion, approximately up to 4 years

Secondary (11)

Response rates
Event free survival (EFS)
Duration of CR and CRc
EFS with molecular MRD relapse
Transfusion independence rate
Show 6 moreShow less
Adverse event profile per CTCAE v5.0
Numbers of Treatment cycle
Treatment cycle duration
Days of treatment per cycle
Patient Reported Outcomes (PRO) by European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC-QLQ-C30)
PRO by EuroQol 5-Dimension 5-Level (EQ-5D-5L)

Arms and interventions

Mesutoclax + AzacitidineExperimental
Venetoclax + AzacitidineActive comparator

Drugs: Mesutoclax (ICP-248), Azacitidine (AZA), Venetoclax

Sites

1 site in 1 country

  • The First Affiliated Hospital, Zhejiang University School of MedicineHangzhou, Zhejiang, China