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Acute Myeloid Leukemia (AML)Phase 3NCT07486479

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

A Phase 3 study testing Mitoxantrone Hydrochloride Liposome, Venetoclax and Azacitidine in people with Acute Myeloid Leukemia (AML), run by The First Affiliated Hospital of Soochow University at 21 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Acute Myeloid Leukemia (AML)
What is being tested?
Mitoxantrone Hydrochloride Liposome, Venetoclax and Azacitidine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
204 participants
Where
21 sitesChina
Study dates
10 Mar 2026to 31 Dec 2027
Phase
Phase 3
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. The patient fully understands the study, voluntarily participates, and has signed the informed consent form (ICF).
  • 2. Aged 18 to 65 years, any gender. 3. Newly diagnosed with AML according to the 2022 WHO classification. 4. Eligible for intensive chemotherapy as determined by the investigator. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 6. Life expectancy ≥ 3 months. 7. Adequate liver and renal function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN) (≤ 5 × ULN for patients with hepatic involvement); total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for patients with hepatic involvement); serum creatinine ≤ 1.5 × ULN.

Who cannot join

  • Patients who meet any of the following criteria will be excluded from the study:
  • Any of the following conditions:
  • 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;
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  • Prior anti-AML therapy (except for leukocytosis management such as hydroxyurea or leukapheresis);
  • History of other malignancies within the past 5 years (except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, or other malignancies that have been effectively controlled without treatment in the past five years);
  • Inability to take oral medication or malabsorption syndrome;
  • Cardiac function or disease meeting any of the following criteria:
  • Long QTc syndrome or QTc interval > 480 ms;
  • Complete left bundle branch block, second- or third-degree atrioventricular block;
  • Severe, uncontrolled arrhythmias requiring medication;
  • New York Heart Association (NYHA) Class ≥ II;
  • Left ventricular ejection fraction (LVEF) < 50%;
  • History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia, or any other significant arrhythmia requiring treatment, clinically significant pericardial disease within 6 months prior to enrollment, or ECG evidence of acute ischemia or active conduction system abnormalities.
  • Uncontrolled systemic illnesses (e.g., active infection, uncontrolled hypertension, diabetes);
  • Human Immunodeficiency Virus (HIV) infection (HIV antibody positive);
  • Active Hepatitis B or C infection (Hepatitis B: HBsAg or HBcAb positive, with HBV-DNA > 1×10³ copies/mL; Hepatitis C: HCV-Ab positive, with HCV-RNA > 1×10³ copies/mL);
  • Known history of immediate or delayed hypersensitivity reaction to drugs of the same class or excipients of the investigational product;
  • Significant neurological or psychiatric history;
  • Pregnant or lactating women;
  • Patients considered by the investigator to be unsuitable for participation in this study.

Trial locations and contacts

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

Xiaowen Tang contact

0512-67780103

tangxiaowen@suda.edu.cn

21 sites in 1 country

China21 sites

  • Changzhou First People's Hospital

    Changzhou, Jiangsu, 213003

    Weiying Gu

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

    Yamin Tan

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022

    Mingzhen Yang

  • Huai'an Second People's Hospital

    Huai'an, Jiangsu, 223002

    Yanming Zhang

  • Shandong First Medical University Affiliated Tumor Hospital

    Jinan, Shandong

    Ji Ma

  • Jingjiang People's Hospital

    Jingjiang, Jiangsu, 214500

    Miao Sun

  • The First People's Hospital Of Lianyungang

    Lianyungang, Jiangsu, 222002

    Ying Wang

  • The Second People's Hospital of Lianyungang

    Lianyungang, Jiangsu, 222006

    Wanchuan Zhuang

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 41003

    Ling Qin

  • Jiangsu Province Hospital of Chinese Medicine

    Nanjing, Jiangsu, 210029

    Xuejun Zhu

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

    Ming Hong

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

    Kourong Miao

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu, 226001

    Hongming Huang

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu, 226001

    Zenghua Lin

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang, 315010

    Guifang Ouyang

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

    Xiaowen Tang

    Depei Wu

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

    Zhenya Hong

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei

    Baixin Ye

  • Wuxi People's Hospital

    Wuxi, Jiangsu, 214023

    Yuanqiang Jiang

  • YanCheng NO.1 People's Hospital

    Yancheng, Jiangsu, 224006

    Yuexin Cheng

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu, 225001

Other trials in China

About this study

Official title: A Prospective, Multicenter, Randomized Controlled Clinical Study of Venetoclax Combined With Azacitidine and Mitoxantrone Hydrochloride Liposome Versus Idarubicin Combined With Cytarabine "3+7" in the Treatment of Newly Diagnosed AML

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.

Read the detailed description

For adult patients with newly diagnosed acute myeloid leukemia (AML) who are eligible for intensive chemotherapy, the standard intensive induction regimen remains anthracycline combined with cytarabine. However, the efficacy of traditional intensive chemotherapy is limited in high-risk AML and is associated with significant myelosuppression and infection risk, underscoring the need for novel therapeutic strategies. This study was therefore designed as a prospective, multicenter, randomized controlled trial. The study plans to enroll 204 adults with newly diagnosed AML. Participants will be randomized in a 2:1 ratio to receive induction therapy with either: 1) venetoclax, azacitidine, and mitoxantrone hydrochloride liposome (MVA), or 2) idarubicin and cytarabine (IA). The primary endpoint is the composite complete remission (CRc) rate following one cycle of induction therapy.

Being tested
Mitoxantrone Hydrochloride Liposome, Venetoclax, Azacitidine, Idarubicin, Cytarabine
Keywords
Acute myeloid leukemia, mitoxantrone hydrochloride liposome, Venetoclax, Azacitidine, Idarubicin, Cytarabine, Randomized Controlled Trial
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

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

  • Mitoxantrone Hydrochloride LiposomeDrug

    Mitoxantrone Hydrochloride Liposome: 24 mg/m², administered by intravenous drip (ivgtt) on day 1

  • VenetoclaxDrug

    Venetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3-9, administered orally (po)

  • AzacitidineDrug

    Azacitidine: 75 mg/m², administered subcutaneously (sc) on days 1-7

  • IdarubicinDrug

    Idarubicin: 12 mg/m², administered by intravenous drip (ivgtt) on days 1-3

  • CytarabineDrug

    Cytarabine: 100 mg/m², administered by intravenous drip (ivgtt) on days 1-7

Study groups in NCT07486479
Study groupRoleWhat they receive
MVAExperimentalPatients achieving complete remission (CR), CR with partial hematologic recovery (CRh), CR with incomplete hematologic recovery (CRi), or morphologic leukemia free state (MLFS) after Cycle 1 proceed to consolidation therapy. Patients achieving a partial response (PR) or demonstrating 50% blast reduction after Cycle 1 receive one additional cycle of re-induction with the same MVA regimen. Those who subsequently achieve CR, CRh, CRi, or MLFS after Cycle 2 proceed to consolidation. Patients with no response (NR) after Cycle 1, or those with NR or PR after Cycle 2, will discontinue study treatment.
Receives: Drug: Mitoxantrone Hydrochloride Liposome; Drug: Venetoclax; Drug: Azacitidine
IAActive comparatorPatients achieving CR, CRh, CRi, or MLFS after Cycle 1 proceed to consolidation therapy. Patients achieving a PR or demonstrating 50% blast reduction after Cycle 1 receive one additional cycle of re-induction with the same IA regimen. Those who subsequently achieve CR, CRh, CRi, or MLFS after Cycle 2 proceed to consolidation. Patients with NR after Cycle 1, or those with NR or PR after Cycle 2, will discontinue study treatment.
Receives: Drug: Idarubicin; Drug: Cytarabine

What is being measured

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

  1. Composite Complete Remission(CRc) rate after one cycle of induction therapy

    Complete remission plus complete remission with partial hematologic recovery plus complete remission with incomplete hematologic recovery (CR+CRh+CRi). Response is assessed according to the the European LeukemiaNet (ELN) 2022 criteria.

    Measured: At the end of the first treatment cycle (Day 28 ± 7), each cycle is 28 days).

Secondary outcomes (11)

  1. Measurable residual disease (MRD) negativity rate (by flow cytometry and molecular testing) among patients who achieved CRc after induction therapy

    Percentage of participants who achieve a CRc MRD- as defined by investigators based on ELN 2022 criteria.

    Measured: At the end of each cycle (Day 28 ± 7), each cycle is 28 days, up to 2 cycles.

  2. Overall response rate(ORR) to induction therapy

    CRc+morphologic leukemia-free state (MLFS)+partial remission (PR). Response is assessed according to the the European LeukemiaNet (ELN) 2022 criteria.

    Measured: At the end of each cycle (Day 28 ± 7), each cycle is 28 days, up to 2 cycles

  3. Time to CRc

    Defined as the time from day 1 of the treatment until the patient achieves CRc. Response is assessed according to the the European LeukemiaNet (ELN) 2022 criteria.

    Measured: Within 100 days from day 1 of treatment.

  4. 1-year relapsed-free survival (RFS) rate

    Defined only for patients achieving CRc. Measured from the date of achievement of remission until the date of hematologic relapse or death from any cause.

    Measured: up to 1 years after the date of the last enrolled participants

  5. 1-year leukemia-free survival (LFS) rate

    Defined only for patients achieving CRc. Measured from day 1 of treatment to the date of first documented leukemia relapse or death from any cause.

    Measured: up to 1 years after the date of the last enrolled participants

  6. 1-year overall survival (OS) rate

    Defined for all patients in the study. Measured from day 1 of treatment to the date of death from any cause.

    Measured: up to 1 years after the date of the last enrolled participants

  7. Incidence of treatment-emergent adverse events, transfusion volume and time to hematologic recovery

    Safety assessments included adverse events (graded by NCI CTCAE v5.0), the number of units of red blood cells and platelets transfused, time to neutrophil recovery to ≥0.5x10⁹/L, and time to platelet recovery to ≥20x10⁹/L.

    Measured: From day 1 of treatment to 28(±7) days after the last dose

  8. Change in Health-Related Quality of Life Assessed by EQ-5D-5L

    EuroQol 5-Dimension 5-Level (EQ-5D-5L) is a standardized instrument for measuring generic health-related quality of life. It comprises a descriptive system (generating a health utility score for cost-utility analysis) and a Visual Analogue Scale (EQ VAS) recording the participant's self-rated health.

    Recommended assessment time points: Baseline, end of Cycle 1 induction therapy (Day 28 ± 7, assessable after completion of bone marrow aspiration), end of Cycle 2 induction therapy (Day 28 ± 7), end of consolidation therapy, first follow-up after transplantation, and follow-up after first relapse.

    Measured: up to 1 years after the date of the last enrolled participants

  9. Change in Cancer-Specific Quality of Life Assessed by EORTC QLQ-C30

    The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) is a cancer-specific instrument. It includes a Global Health Status/Quality of Life scale, five functional scales (physical, role, emotional, cognitive, social), and nine symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).

    Recommended assessment time points: Baseline, end of Cycle 1 induction therapy (Day 28 ± 7, assessable after completion of bone marrow aspiration), end of Cycle 2 induction therapy (Day 28 ± 7), end of consolidation therapy, first follow-up after transplantation, and follow-up after first relapse.

    Measured: up to 1 years after the date of the last enrolled participants

  10. Total Direct Medical Costs

    Total direct medical costs (including costs of study drugs, concomitant medications, hospitalization, outpatient visits, laboratory tests, and management of adverse events) incurred over the study period. Costs will be estimated based on patient-level resource utilization data collected during the trial and, if applicable, extrapolated using a long-term simulation model.

    Unit of Measure: Currency (CNY)

    Measured: up to 1 year after the date of the last enrolled participant

  11. Quality-Adjusted Life Years (QALYs)

    Quality-adjusted life years gained, calculated by integrating survival data with health utility weights derived from the EQ-5D-5L questionnaire administered at specified time points during the trial. A long-term simulation model may be used to extrapolate QALYs beyond the observation period.

    Unit of Measure: Years

    Measured: up to 1 year after the date of the last enrolled participant

Timeline

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

  1. First posted20 Mar 2026
  2. Study start10 Mar 2026 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
204 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07486479
Sponsor's protocol ID
CSPC-DED-AML-K23
Status last verified
Mar 2026
First submitted
22 Dec 2025
Last updated
20 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mitoxantrone Hydrochloride Liposome, Venetoclax and Azacitidine in people with Acute Myeloid Leukemia (AML), run by The First Affiliated Hospital of Soochow University at 21 sites 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 2 inclusion and 23 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: opening soon, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Xiaowen Tang (0512-67780103, tangxiaowen@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(CRc) rate after one cycle of induction therapy (time frame: At the end of the first treatment cycle (Day 28 ± 7), each cycle is 28 days).). 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 NCT07486479.

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 20 Mar 2026.

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