Venetoclax, Azacitidine, and Mitoxantrone Hydrochloride Liposome Versus Idarubicin and Cytarabine in Newly Diagnosed AML

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe First Affiliated Hospital of Soochow University

About this trial

This study aims to evaluate the efficacy and safety of venetoclax combined with azacitidine and mitoxantrone hydrochloride liposome (MVA) versus idarubicin combined with cytarabine (IA) in the treatment of newly diagnosed AML.

Eligibility criteria

Qualifiers

1. The patient fully understands the study, voluntarily participates, and has signed the informed consent form (ICF).

Disqualifiers

Acute promyelocytic leukemia (APL);

Central nervous system leukemia (CNSL);

AML secondary to chemotherapy/radiotherapy for other malignancies or antecedent hematological disorders (e.g., MDS, MPN, CML);

Prior treatment with hypomethylating agents (HMA) or venetoclax;

Trial design

Treatments tested in this trial

  • Mitoxantrone Hydrochloride Liposome
  • Venetoclax
  • Azacitidine
  • Idarubicin
  • Cytarabine

Treatment groups

204 Participants
are divided into 2 treatment groups

Sponsors and collaborators

The First Affiliated Hospital of Soochow University

Lead sponsor

CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

Collaborator