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New hope for AML: Three-Drug combo aims to boost remission

NCT ID NCT07486479

Disease control Sponsor: The First Affiliated Hospital of Soochow University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tests a new combination of drugs (venetoclax, azacitidine, and a liposomal form of mitoxantrone) against the standard therapy for adults newly diagnosed with acute myeloid leukemia (AML). The study will enroll 204 people aged 18-65 to see if the new combo leads to more complete remissions. The goal is to find a more effective initial treatment for this aggressive blood cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
venetoclax, azacitidine, and mitoxantrone hydrochloride liposome
What this could lead to
If successful, this could offer a more effective first-line treatment option for people with newly diagnosed AML, potentially leading to higher remission rates.
What could go wrong
This is an early-stage Phase 3 trial, so results are not yet known. The new combination may not be more effective than the standard treatment and could have unexpected side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 204 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * Patients who meet any of the following criteria will be excluded from the study: 1. Any of the following conditions: 1. Acute promyelocytic leukemia (APL); 2. Central nervous system leukemia (CNSL); 3. AML secondary to chemotherapy/radiotherapy for other malignancies or antecedent hematological disorders (e.g., MDS, MPN, CML); 2. Prior treatment with hypomethylating agents (HMA) or venetoclax; 3. Prior anti-AML therapy (except for leukocytosis management such as hydroxyurea or leukapheresis); 4. 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); 5. Inability to take oral medication or malabsorption syndrome; 6. Cardiac function or disease meeting any of the following criteria: 1. Long QTc syndrome or QTc interval \> 480 ms; 2. Complete left bundle branch block, second- or third-degree atrioventricular block; 3. Severe, uncontrolled arrhythmias requiring medication; 4. New York Heart Association (NYHA) Class ≥ II; 5. Left ventricular ejection fraction (LVEF) \< 50%; 6. 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. 7. Uncontrolled systemic illnesses (e.g., active infection, uncontrolled hypertension, diabetes); 8. Human Immunodeficiency Virus (HIV) infection (HIV antibody positive); 9. 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); 10. Known history of immediate or delayed hypersensitivity reaction to drugs of the same class or excipients of the investigational product; 11. Significant neurological or psychiatric history; 12. Pregnant or lactating women; 13. Patients considered by the investigator to be unsuitable for participation in this study.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myeloid leukemia (AML)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    21 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu, 226001, China

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu, 226001, China

  • Changzhou First People's Hospital

    Changzhou, Jiangsu, 213003, China

  • Huai'an Second People's Hospital

    Huai'an, Jiangsu, 223002, China

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029, China

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029, China

  • Jiangsu Province Hospital of Chinese Medicine

    Nanjing, Jiangsu, 210029, China

  • Jingjiang People's Hospital

    Jingjiang, Jiangsu, 214500, China

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu, 225001, China

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, China

  • Shandong First Medical University Affiliated Tumor Hospital

    Jinan, Shandong, China

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022, China

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

    Luoyang, Henan, 41003, China

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang, 315010, China

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006, China

  • The First People's Hospital Of Lianyungang

    Lianyungang, Jiangsu, 222002, China

  • The Second People's Hospital of Lianyungang

    Lianyungang, Jiangsu, 222006, China

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

    Wuhan, Hubei, 430030, China

  • Wuxi People's Hospital

    Wuxi, Jiangsu, 214023, China

  • YanCheng NO.1 People's Hospital

    Yancheng, Jiangsu, 224006, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.