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Acute Myeloid LeukemiaNCT05941585

Mitoxantrone Hydrochloride Liposome Combined With Chemotherapy in Untreated de Novo Acute Myeloid Leukemia

A study testing Mitoxantrone hydrochloride liposome injection30mg/m2, HomoharringtonineD1-D7(2mg/m2/day) and Venetoclax (d4 100mg/day, d5200mg/day ,d6-d12 400mg/day) in people with Acute Myeloid Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the safety, efficacy and pharmacokinetics of mitoxantrone hydrochloride liposome injection combined with chemotherapy in previously untreated de novo acute myeloid leukemia. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Mitoxantrone hydrochloride liposome injection30mg/m2, HomoharringtonineD1-D7(2mg/m2/day) and Venetoclax (d4 100mg/day, d5200mg/day ,d6-d12 400mg/day)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
8 Aug 2023to 17 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

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

  • Able to understand the study and voluntarily sign informed consent.
  • Age: 18~65 (including 18) years old, gender unlimited.
  • Patients diagnosed with acute myeloid leukemia according to "The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia" who haven't been treated.
  • Eastern Cooperative Oncology Group (ECOG) physical state score: 0-1.
  • Fit for intensive chemotherapy.
  • The function of main organs should meet the following standards before treatment:
  • Kidney: Serum creatinine ≤ 1.5 × Upper limit of normal range (ULN) Liver: Total bilirubin ≤ 1.5 × ULN, AST and ALT ≤ 3× ULN
  • Patients should agree to use contraception (such as intrauterine device [IUD], contraceptive pill or condom) during the study period and within 6 months after the end of the study; Female patients must have a negative serum pregnancy test within 7 days before enrollment.

Who cannot join

  • Any of the following cases:(1) diagnosed as acute promyelocytic leukemia (APL);(2) chronic myelogenous leukemia in blast crisis;(3) AML with central nervous system leukemia.
  • AML arising from prior cytotoxic chemotherapy or radiotherapy for other tumours.
  • Patient has been previously diagnosed with another malignancy in last 5 years (except for cured basal cell carcinoma of skin or cervical carcinoma in situ).
  • Has been previously treated with doxorubicin or other anthracyclines and drugs for AML.
  • Allergic history of mitoxantrone hydrochloride injection or any other drugs used in this study.
  • Those on systemic anti-infective therapy with poorly controlled infection (signs of infection progression within 1 week prior to the first dose, or as determined by the investigator).
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  • Patient who is suffering from severe hemorrhagic diseases, such as haemophilia A, haemophilia B, von Willebrand disease and any other spontaneous bleeding require medical treatment.
  • The estimated survival time is less than 3 months.
  • Any of the following conditions occurs in cardiac function:(1) Long QTc syndrome or QTc interval > 480 ms;(2) Complete left bundle branch block or severe atrioventricular block disease (without a pacemaker);(3) Serious and uncontrolled arrhythmias and unstable angina pectoris requiring drug treatment;(4) History of chronic congestive heart failure, New York Heart Association (NYHA)≥grade 3;(5) The cardiac ejection fraction is less than 50% in Echocardiography;(6)Uncontrollable hypertension (defined as multiple measurements of systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg under drug control);(7) History of myocardial infarction, unstable angina pectoris, viral myocarditis or severe pericardial disease, ECG evidence of acute ischemia or active conduction system abnormalities within 6 months before first dose.
  • Patients have thromboembolic events within 6 months prior to first dose, such as cerebrovascular accidents (including transient ischemic attack) and pulmonary embolism.
  • HBsAg/HBcAb positive with HBV-DNA higher than the lower limit of the detection value of the research center , hepatitis C antibody-positive with HCV-RNA higher than the lower limit of the detection value of the research center, or HIV antibody positive in the preliminary screening.
  • Patients who have been treated with strong/moderate CYP3A inducers/inhibitors or P-gp inhibitors within 7 days prior to first dose (for treatment group 3 only).
  • Patients who cannot take oral medications or have absorption disorder (for treatment group 3 only).
  • Patient is suffering from any serious and /or non-controllable disease, or the investigator determines that the disease might affect the participation of patients in the study, including (but not limited to, uncontrolled diabetes, dialysis related kidney diseases, severe liver diseases, life-threatening autoimmune diseases and hemorrhagic diseases, drug abuse, neurological diseases, etc.).
  • Pregnant or lactating female.
  • Patients who are not suitable for this study as decided by the investigator due to other reasons.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin, 300020

Other trials in China

About this study

Official title: A Clinical Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Mitoxantrone Hydrochloride Liposome Injection Combined With Chemotherapy in Previously Untreated de Novo Acute Myeloid Leukemia

The purpose of this study is to determine the safety, efficacy and pharmacokinetics of mitoxantrone hydrochloride liposome injection combined with chemotherapy in previously untreated de novo acute myeloid leukemia.

Read the detailed description

This is a prospective, multi-center, randomized, open-label, three-arm clinical study to explore the efficacy among three chemotherapy regimens combined with mitoxantrone hydrochloride liposome in previously untreated de novo acute myeloid leukemia. Patients will be randomized to different treatment group and be given different induction therapy in the first cycle. If patients do not achieve Morphologic Leukemia-free State (MLFS) after the first induction cycle, they will receive the second induction therapy with mitoxantrone hydrochloride liposome, cytarabine and venetoclax. Mitoxantrone hydrochloride liposome will be given on day 1 at the dose of 24 mg/m2 or 30 mg/m2 and be combined with cytarabine, venetoclax or homoharringtonine. A maximum of 2 cycles of induction therapy are planned.

Being tested
Mitoxantrone hydrochloride liposome injection30mg/m2, HomoharringtonineD1-D7(2mg/m2/day), Venetoclax (d4 100mg/day, d5200mg/day ,d6-d12 400mg/day), Cytarabine(standard-dose:d1-d7100mg/m2/day), Cytarabine(intermediate-dose:d1-d4100mg/m2/day, d5-d7 1g/m2)
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 liposome injection30mg/m2Drug

    Mitoxantrone hydrochloride liposome intravenous infusion on day 1 (30mg/m2)

  • HomoharringtonineD1-D7(2mg/m2/day)Drug

    Homoharringtonine intravenous infusion on D1-D7,2mg/m2/day in a 4-week treatment cycle.

  • Venetoclax (d4 100mg/day, d5200mg/day ,d6-d12 400mg/day)Drug

    Venetoclax d4-d12 (d4 100mg/day, d5200mg/day ,d6-d12 400mg/day)in a 4-week treatment cycle.

  • Cytarabine(standard-dose:d1-d7100mg/m2/day)Drug

    Cytarabine intravenous infusion on d1-d7 ,100mg/m2/day

  • Cytarabine(intermediate-dose:d1-d4100mg/m2/day, d5-d7 1g/m2)Drug

    d1-d4100mg/m2/day, d5-d7 1g/m2

  • Mitoxantrone hydrochloride liposome injection24mg/m2Drug

    Mitoxantrone hydrochloride liposome intravenous infusion on day 1 (24mg/m2)

Study groups in NCT05941585
Study groupRoleWhat they receive
mitoxantrone hydrochloride liposome injection combined with of cytarabineExperimentalPatients will receive mitoxantrone hydrochloride liposome injection combined with standard-dose of cytarabine.
Receives: Drug: Mitoxantrone hydrochloride liposome injection30mg/m2; Drug: Cytarabine(standard-dose:d1-d7100mg/m2/day)
mitoxantrone hydrochloride liposome with cytarabine and homoharringtonineExperimentalPatients will receive mitoxantrone hydrochloride liposome injection combined with intermediate-dose of cytarabine and homoharringtonine.
Receives: Drug: HomoharringtonineD1-D7(2mg/m2/day); Drug: Cytarabine(intermediate-dose:d1-d4100mg/m2/day, d5-d7 1g/m2); Drug: Mitoxantrone hydrochloride liposome injection24mg/m2
mitoxantrone hydrochloride liposome injection combined with cytarabine and venetoclaxExperimentalPatients will receive mitoxantrone hydrochloride liposome injection with cytarabine and venetoclax.
Receives: Drug: Mitoxantrone hydrochloride liposome injection30mg/m2; Drug: Venetoclax (d4 100mg/day, d5200mg/day ,d6-d12 400mg/day); Drug: Cytarabine(standard-dose:d1-d7100mg/m2/day)

What is being measured

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

  1. Incidence of treatment-emergent adverse events (TEAEs)

    The frequency and severity of adverse events during treatment, abnormalities in vital signs, physical examinations, laboratory tests, etc

    Measured: Up to approximately one month

Secondary outcomes (8)

  1. Complete remission rate（CR）

    Proportion of patients with complete remission

    Measured: Up to approximately nine weeks

  2. Complete remission or complete remission with partial hematologic recovery (CR/CRh)

    Proportion of patients with complete remission or complete remission with partial hematologic recovery.

    Measured: Up to approximately nine weeks

  3. Composite remission rate (CRc)

    Proportion of subjects with complete remission (CR) or complete remission with partial hematologic recovery (CRh) or complete remission with incomplete hematologic recovery (Cri).

    Measured: Up to approximately nine weeks

  4. Minimal Residual Disease (MRD)-negative composite remission rates

    Among those who have achieved composite remission, proportion of patients who is MRD-negative.

    Measured: Up to approximately nine weeks

  5. Event-free survival (EFS)

    It is defined as the time from the start of randomization to the occurrence of induction failure or disease progression or death from any cause (whichever occurs first).

    Measured: Up to approximately 3 years.

  6. Relapse-free Survival (RFS)

    It is defined as the time from the start of achieving remission to disease progression, death from any cause or the last follow-up

    Measured: Up to approximately 3 years.

  7. Overall survival (OS)

    It is defined as the time from the start of randomization to the death from any cause.

    Measured: Up to approximately 3 years.

  8. Blood concentrations of total and free mitoxantrone.

    Blood was taken to measure the required concentration at different time points

    Measured: 30 minutes before administration and 5min, 6, 24, 72, 144, 288, 432, 648 hours after administration of Mitoxantrone hydrochloride liposome on day 1

Timeline

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

  1. First posted12 Jul 2023
  2. Study start8 Aug 2023
  3. Primary completion17 Jan 2025
  4. Study completion17 Jan 2025

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05941585
Sponsor's protocol ID
IIT2023004
Status last verified
Feb 2025
First submitted
1 Jul 2023
Last updated
3 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Mitoxantrone hydrochloride liposome injection30mg/m2, HomoharringtonineD1-D7(2mg/m2/day) and Venetoclax (d4 100mg/day, d5200mg/day ,d6-d12 400mg/day) in people with Acute Myeloid Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China 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 8 inclusion and 16 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: finished, as of the sponsor's last update on 3 Jun 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-emergent adverse events (TEAEs) (time frame: Up to approximately one month). 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 NCT05941585.

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 3 Jun 2025.

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