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Acute Monocytic LeukemiaPhase 2NCT05566054

Venetoclax and Azacitidine Combined With Chidamide (VAC) for the Treatment of Newly Diagnosed Acute Monocytic Leukemia

A Phase 2 study testing Chidamide, Azacitidine and Venetoclax in people with Acute Monocytic Leukemia and Newly Diagnosed, run by The First Affiliated Hospital of Soochow University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is to investigate the therapeutic efficacy and side effect of venetoclax, azacytidine combined with chidamide for newly diagnosed acute monocytic leukemia patients that are ineligible for intensive chemotherapy Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Monocytic Leukemia, Newly Diagnosed
What is being tested?
Chidamide, Azacitidine and Venetoclax
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteChina
Study dates
1 Mar 2022to 30 Sep 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmation of acute monocytic leukemia( AML-M5) diagnosis by the French-American-British (FAB) Classification and/or characterized for expression of monocytic and myeloid differentiation markers, have a projected life expectancy of at least 12 weeks, previously untreated, and ineligible for treatment with intensive chemotherapy.
  • Patients must be considered ineligible for induction therapy defined by the following:
  • >= 60 years of age
  • >=18 to 59years of age with at least one of the following comorbidities:
  • Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy:
  • (A)Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3. (B)Cardiac history of congestive heart failure requiring treatment or ejection fraction <= 50% or chronic stable angina.
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  • (C)Diffusing capacity of the lung for carbon monoxide (DLCO) <= 65% or forced expiratory volume during the first second (FEV1) <= 65%.
  • (D)Creatinine clearance >= 30 mL/min to < 45 mL/min. (E)Moderate hepatic impairment with total bilirubin > 1.5 to <= 3.0 × upper limit of normal (ULN).
  • Must meet the laboratory requirements per the protocol.
  • Female participant must not be pregnant or breastfeeding and is not considering becoming pregnant or donating eggs during the study or for approximately 90 days after the last dose of study drug.
  • Female participants of childbearing potential must agree to use at least 1 protocol-specified method of birth control and male participants, if sexually active with female partner(s) of childbearing potential, must agree to practice the protocol-specified contraception.
  • Did not receive radiotherapy, chemotherapy, targeted therapy or hematopoietic stem cell transplantation within 4 weeks before enrollment;
  • Other comorbidities that are not suitable for intensive chemotherapy;
  • The patient refused to receive intensive chemotherapy;
  • Ability to understand and willing to sign the informed consent for this trial.

Who cannot join

  • Patients who are allergic to the study drug or drugs with similar chemical structures
  • Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception
  • Active infection
  • Active bleeding
  • Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment
  • Patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met
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  • Liver function abnormalities (total bilirubin > 1.5 times the upper limit of the normal range, ALT/AST > 2.5 times the upper limit of the normal range or patients with liver involvement whose ALT/AST > 1.5 times the upper limit of the normal range), or renal anomalies (serum creatinine > 1.5 times the upper limit of the normal value)
  • Patients with a history of clinically significant QTc interval prolongation (male > 450 ms; female > 470 ms), ventricular heart tachycardia and atrial fibrillation, II-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment
  • Urgery on the main organs within the past six weeks
  • Drug abuse or long-term alcohol abuse that would affect the evaluation results
  • Patients who have received organ transplants (excepting bone marrow transplantation)
  • Patients not suitable for the study according to the investigator's assessment

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sheng-Li Xue, M. D. contact

008651267781139

slxue@suda.edu.cn

China1 site, 1 recruiting

  • The First Affliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

    Sheng-Li Xue, M.D., +86 512 6778 1139, slxue@suda.edu.cn

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Randomized, Controlled Clinical Trial of Venetoclax, Azacytidine Combined With Chidamide for the Treatment of Newly Diagnosed Acute Monocytic Leukemia Patients That Are Ineligible for Intensive Chemotherapy

This study is to investigate the therapeutic efficacy and side effect of venetoclax, azacytidine combined with chidamide for newly diagnosed acute monocytic leukemia patients that are ineligible for intensive chemotherapy

Read the detailed description

Acute myeloid leukemia (AML) is one of the most aggressive blood cancers, with a very low survival rate and few options for patients who are unable to undergo intensive chemotherapy. Venetoclax in combination with hypomethylation agents or cytarabine has been approved by the Food and Drug Administration (FDA) for the treatment of patients with newly diagnosed AML unfit for intensive chemotherapy. However, resistance to venetoclax can be acquired through the upregulation of anti-apoptotic proteins in the BCL2 family, such as myeloid cell leukaemia 1 (MCL1). MCL1 plays a critical role in cell apoptosis regulation and high expression of MCL1 is observed in acute monocytic leukemia (AML-M5) . Chidamide, a newly designed selective histone deacetylase inhibitor, resulted in a decrease in the protein level of MCL1. This study is to investigate the therapeutic efficacy and side effect of venetoclax, azacytidine combined with chidamide for newly diagnosed AML-M5 patients that are ineligible for intensive chemotherapy.

Being tested
Chidamide, Azacitidine, Venetoclax
Keywords
Chidamide, Azacitidine, Venetoclax
Medical subject headings
Leukemia, Monocytic, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChidamideDrug

    Chidamide 10mg orally daily for 7 days (d1-d7)

  • AzacitidineDrug

    azacytidine 75mg/m2 daily for 7 days (d1-d7)

  • VenetoclaxDrug

    Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-28)

Study groups in NCT05566054
Study groupRoleWhat they receive
VAC groupExperimentalChidamide 10mg orally daily for 7 days (d1-d7), AZA 75mg/m2 daily for 7 days (d1-d7) and VEN orally once daily (100 mg d1, 200 mg d2, 400 mg d3-28); If the bone marrow assessment is CR/CRi/MLFS/PR/NR on the 21th-28th day in the first cycle, the second cycle of treatment will be started; If the bone marrow assessment is PR/NR, the patient needs to withdraw from the trial, If the bone marrow assessment is CR/CRi/MLFS, the patient will start post-remission therapy. For post-remission therapy, if the patients ineligible for intensive chemotherapy, continue with the same regimen until progression or recurrence of the disease, and the patients need to withdraw from the trial. If the patients were fit for intensive chemotherapy, patients will receive consolidation chemotherapy with other regimens or transplantation, and the patients needs to withdraw from the trial if progression or recurrence of the disease.
Receives: Drug: Chidamide; Drug: Azacitidine; Drug: Venetoclax
VA groupActive comparatorAZA 75mg/m2 daily for 7 days (d1-d7) and VEN orally once daily (100 mg d1, 200 mg d2, 400 mg d3-28); If the bone marrow assessment is CR/CRi/MLFS/PR/NR on the 21th-28th day in the first cycle, the second cycle of treatment will be started; If the bone marrow assessment is still PR/NR, the patient needs to enter VEN+AZA+Chidamide group. If the bone marrow assessment is CR/CRi/MLFS, the patient will start post-remission therapy. For post-remission therapy, if the patients ineligible for intensive chemotherapy, continue with the same regimen until progression or recurrence of the disease, and the patient needs to withdraw from the trial. If the patients fit for intensive chemotherapy, patients will receive consolidation chemotherapy with other regimens or transplantation, and the patient needs to withdraw from the trial if progression or recurrence of the disease.
Receives: Drug: Azacitidine; Drug: Venetoclax

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite Complete Remission Rate

    The composite complete remission rate(complete remission plus complete remission with incomplete blood cell count recovery)

    Measured: At the end of Cycle 1 or 2 (each cycle is 28 days)

  2. Overall response rate (ORR)

    The overall response (completed remission without minimal residual disease, completed remission with incomplete blood count recovery, morphologic leukemia-free state and partial remission)

    Measured: At the end of Cycle 1 or 2 (each cycle is 28 days)

Secondary outcomes (5)

  1. Duration of Response (DOR)

    It is measured the time from initial response to subsequent disease progression or relapse

    Measured: 1 year

  2. Overall Survival (OS)

    It is measured from the time of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive

    Measured: 1 year

  3. Progression-Free Survival (PFS)

    It is measured from the time from randomization to progression or death

    Measured: 1 year

  4. Adverse reactions in hematology

    Record of adverse events in hematological system during and after VEN+AZA+Chidamide regimen induction (agranulocytosis days, PLT/RBC transfusion units)

    Measured: At the end of Cycle 1 (each cycle is 28 days)

  5. Nonhematological adverse reactions

    Record of adverse events in other organs or systmes during and after VEN+AZA+Chidamide regimen induction (infection and organ injury)

    Measured: At the end of Cycle 1 (each cycle is 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2022
  2. Study start1 Mar 2022
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
92 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05566054
Sponsor's protocol ID
SZAMLM5
Status last verified
Nov 2025
First submitted
30 Sep 2022
Last updated
21 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chidamide, Azacitidine and Venetoclax in people with Acute Monocytic Leukemia and Newly Diagnosed, run by The First Affiliated Hospital of Soochow University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sheng-Li Xue, M. D. (008651267781139, slxue@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite Complete Remission Rate (time frame: At the end of Cycle 1 or 2 (each cycle is 28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05566054.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.

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