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

November 3, 2026 updated by: Beijing InnoCare Pharma Tech Co., Ltd.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
318

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310012
        • The First Affiliated Hospital, Zhejiang University school of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Study participants with newly diagnosed AML (excluding acute promyelocytic leukemia [APL]) confirmed per the 2022 World Health Organization (WHO) classification criteria.
  2. Age ≥65 years; or age ≥18 years and <65 years and ineligible for intensive chemotherapy.
  3. The participant is expected to have a survival time of at least 12 weeks.
  4. For participants aged ≥65 years: ECOG Performance Status (PS) 0-2; for participants aged ≥18 years and <65 years: ECOG PS 0-3.
  5. Participants must have adequate hepatic and renal function.
  6. 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.
  7. 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.
  8. The participant is able to communicate adequately with the investigator and comply with study procedures as specified in the protocol.
  9. The participant or their legally authorized representative voluntarily provides written informed consent.

Exclusion Criteria:

  1. Prior antitumor treatment for myeloid hematologic malignancies.
  2. Prior history of chronic myeloid leukemia (CML), myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN).
  3. Known central nervous system (CNS) involvement of leukemia.
  4. Peripheral blood white blood cell count >25×10^9/L prior to randomization.
  5. Active hepatitis B virus or hepatitis C virus infection.
  6. History of immunodeficiency, including positive human immunodeficiency virus (HIV) antibody.
  7. 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.
  8. Diagnosis of another active malignant neoplasm within the past 2 years.
  9. Severe active infection requiring intravenous antimicrobial therapy.
  10. History of severe cardiovascular disease.
  11. Prior history of central nervous system disorders.
  12. History of severe bleeding diathesis.
  13. Known alcohol or substance dependence.
  14. 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.
  15. Pregnant or breastfeeding female participants.
  16. Malabsorption syndrome or other conditions that preclude oral administration or may interfere with drug absorption.
  17. Known hypersensitivity to the active ingredients/excipients of mesutoclax tablets, venetoclax, azacitidine, or mannitol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mesutoclax + Azacitidine
Drug: Mesutoclax (ICP-248)

125 mg QD, orally, until disease progression or other reasons for treatment discontinuation, whichever comes first.

Drug: Azacitidine (AZA)

75 mg/m2, Day 1-7 or Day 1-5 and Day 8-9 of each Cycle, by injection
Active Comparator: Venetoclax + Azacitidine
Drug: Azacitidine (AZA)

75 mg/m2, Day 1-7 or Day 1-5 and Day 8-9 of each Cycle, by injection

Drug: Venetoclax

400 mg QD, orally, until disease progression or other reasons for treatment discontinuation, whichever comes first.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
overall survival (OS)
Time Frame: through the study completion, approximately up to 4 years
through the study completion, approximately up to 4 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Response rates
Time Frame: within 3 cycles (each cycle is 28 days) and during study treatment, approximately up to 3 years

Rate of complete remission with negative measurable residual disease (CRMRD-), complete remission (CR) rate, and composite complete remission (CRc) rate (CRc includes CR, CR with incomplete hematologic recovery [CRi] , and/or CR with partial hematological recovery(CRh))
within 3 cycles (each cycle is 28 days) and during study treatment, approximately up to 3 years
Event free survival (EFS)
Time Frame: approximately up to 3 years
approximately up to 3 years
Duration of CR and CRc
Time Frame: during study treatment period, approximately up to 3 years

Duration of CR and duration of CRc
during study treatment period, approximately up to 3 years
EFS with molecular MRD relapse
Time Frame: approximately up to 3 years

Mesured from the date of randomization to date of treatment failure, hematological relapse, MRD relapse, or death from any cause, whichever comes first
approximately up to 3 years
Transfusion independence rate
Time Frame: approximately up to 3 years

Transfusion independence rate
approximately up to 3 years
Adverse event profile per CTCAE v5.0
Time Frame: from first dose to 28 days post last dose, approximately up to 3 years

Incidence, category, severity, and other characteristics of adverse events (AEs), assessed per NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
from first dose to 28 days post last dose, approximately up to 3 years
Numbers of Treatment cycle
Time Frame: during study treatment period, approximately up to 3 years
during study treatment period, approximately up to 3 years
Treatment cycle duration
Time Frame: during study treatment period, approximately up to 3 years
during study treatment period, approximately up to 3 years
Days of treatment per cycle
Time Frame: during study treatment period, approximately up to 3 years
during study treatment period, approximately up to 3 years
Patient Reported Outcomes (PRO) by European Organization for Research and Treatment of Cancer -Quality of Life Questionnaire (EORTC-QLQ-C30)
Time Frame: from first dose to 28 days post last dose, approximately up to 3 years

PROs assessed by EORTC-QLQ-C30 , changes in rating compared to baseline.
from first dose to 28 days post last dose, approximately up to 3 years
PRO by EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Time Frame: from first dose to 28 days post last dose, approximately up to 3 years

PROs assessed by EQ-5D-5L, changes in rating compared to baseline.
from first dose to 28 days post last dose, approximately up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing InnoCare Pharma Tech Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Qian Jiang, Peking University People's Hospital
  • Principal Investigator: Jie Jin, First Affiliated Hospital of Zhejiang University
  • Principal Investigator: Jianxiang Wang, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ICP-CL-01210

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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