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Acute Myeloid Leukemia (AML)Phase 1NCT07828535

Liposomal Mitoxantrone Plus Azacitidine and Venetoclax in Newly Diagnosed Elderly or Unfit AML

A Phase 1 study testing Liposome Mitoxantrone, Venetoclax and Azacitidine in people with Acute Myeloid Leukemia (AML), run by Institute of Hematology & Blood Diseases Hospital, China.

Not yet recruiting

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

Official record
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Trial summary

This prospective, open-label, multicenter phase Ib trial will evaluate the safety, tolerability, and RP2D of the VAM regimen (liposomal mitoxantrone + azacitidine [AZA] + venetoclax [VEN]) in elderly or unfit patients with newly diagnosed AML. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Acute Myeloid Leukemia (AML)
What is being tested?
Liposome Mitoxantrone, Venetoclax and Azacitidine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
30 Oct 2026to 31 Dec 2032
Phase
Phase 1
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 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects eligible for enrollment in this study must meet all of the following criteria:
  • Diagnosis of acute myeloid leukemia (AML) according to the WHO 2022 or ICC criteria, excluding acute promyelocytic leukemia (APL).
  • No prior therapy for AML, except hydroxyurea for the management of hyperleukocytosis.
  • Meeting at least one of the following criteria:
  • Age ≥ 75 years;
  • Age 18-74 years with at least one of the following conditions precluding suitability for intensive chemotherapy:
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  • ECOG performance status 2-3; ii. Cardiac dysfunction with left ventricular ejection fraction (LVEF) ≤ 50%; iii. Pulmonary dysfunction with diffusing capacity of the lung for carbon monoxide (DLCO) ≤ 65% or forced expiratory volume in 1 second (FEV1) ≤ 65%; iv. Creatinine clearance 30-45 mL/min; v. Other major organ dysfunction or comorbidities that, in the investigator's judgment, render the patient unsuitable for intensive chemotherapy.
  • ECOG performance status 0-3.
  • Life expectancy ≥ 3 months.
  • Patients of childbearing potential agree to use effective contraception during the treatment period and for at least 6 months after the last dose of study treatment.
  • Voluntary written informed consent provided.

Who cannot join

  • Subjects who meet any of the following criteria will not be eligible for enrollment in this study:
  • Acute promyelocytic leukemia (APL)..
  • Active central nervous system (CNS) leukemia.
  • Prior targeted therapy or chemotherapy for AML, excluding hydroxyurea.
  • Uncontrolled active infection.
  • Uncontrolled cardiovascular disease: New York Heart Association (NYHA) class III-IV heart failure, myocardial infarction or unstable angina within 6 months before enrollment, or uncontrolled hypertension.
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  • Left ventricular ejection fraction (LVEF) < 40%.
  • Concurrent active malignancy, except for cured non-melanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer.
  • Known hypersensitivity to the study drugs or their excipients.
  • Pregnant or breastfeeding women.
  • Any other condition that, in the investigator's judgment, would make the patient unsuitable for study participation.

About this study

Official title: A Phase Ib Study of Liposomal Mitoxantrone Combined With Azacitidine and Venetoclax in Newly Diagnosed Elderly or Unfit Patients With Acute Myeloid Leukemia

This prospective, open-label, multicenter phase Ib trial will evaluate the safety, tolerability, and RP2D of the VAM regimen (liposomal mitoxantrone + azacitidine [AZA] + venetoclax [VEN]) in elderly or unfit patients with newly diagnosed AML. A standard 3+3 dose escalation will enroll 12-30 patients, testing liposomal mitoxantrone at 8, 12, 16, and 20 mg/m². VEN duration (9 vs. 14 days) will be determined at the 8 mg/m² dose level, after which only liposomal mitoxantrone will be escalated while AZA and VEN will remain fixed.

Induction therapy will consist of up to two 28-day cycles. Responders achieving CR/CRi/MLFS will be eligible for up to 4 consolidation cycles (total ≤6 cycles), after which they will proceed to maintenance with either AZA+VEN or observation.

Being tested
Liposome Mitoxantrone, Venetoclax, Azacitidine
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.

  • Liposome MitoxantroneDrug

    Liposome Mitoxantrone: 8, 12, 16, and 20 mg/m², administered by intravenous drip (ivgtt) on day 1, every 4 weeks

  • VenetoclaxDrug

    Venetoclax(9 days): 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3-9, administered orally (po), every 4 weeks Venetoclax(14 days): 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3-14, administered orally (po), every 4 weeks

  • AzacitidineDrug

    Azacitidine: 75 mg/m², administered subcutaneously (sc) on days 1-7, every 4 weeks

Study groups in NCT07828535
Study groupRoleWhat they receive
Venetoclax, azacitidine combined with liposome mitoxantrone as induction regimenExperimentalThe trial will employ a standard 3+3 dose escalation design, testing liposomal mitoxantrone at 8, 12, 16, and 20 mg/m². VEN duration (9 vs. 14 days) will be determined at the 8 mg/m² dose level, after which only liposomal mitoxantrone will be escalated while AZA and VEN will remain fixed. Venetoclax duration will be sequentially escalated (9 vs. 14 days), choosing the longest duration without dose-limiting toxicity (DLT) in 3-6 evaluable patients. The RP2D for liposomal mitoxantrone is the highest dose with ≤1 DLT in 6 patients; if DL4 is tolerated, RP2D = 20 mg/m² on day 1.
Receives: Drug: Liposome Mitoxantrone; Drug: Venetoclax; Drug: Azacitidine

What is being measured

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

  1. Dose-Limiting Toxicity (DLT)

    To evaluate the safety, tolerability, and RP2D of the VAM regimen in newly diagnosed elderly/unfit AML patients.

    Measured: Cycle 1(up to 42 days)

  2. Incidence of treatment-related adverse events

    The safety of the drug was evaluated by NCI-CTC AE 5.0 standard which including hematologic and non-hematologic toxicity

    Measured: From day 1 of treatment to 28 days after the last dose

  3. Composite complete remission (CRc) rate

    Proportion of patients with complete remission (CR), complete remission with incomplete hematologic recovery (CRi) or morphologic leukemia-free state (MLFS)

    Measured: Up to approximately eight weeks

Secondary outcomes (11)

  1. Complete remission (CR) rate

    Proportion of patients with complete remission (CR)

    Measured: Up to approximately eight weeks

  2. Complete remission with incomplete hematologic recovery (CRi) rate

    Proportion of patients with complete remission with incomplete hematologic recovery (CRi)

    Measured: Up to approximately eight weeks

  3. Morphologic leukemia-free state (MLFS) rate

    Proportion of patients with morphologic leukemia-free state (MLFS)

    Measured: Up to approximately eight weeks

  4. Event-free survival (EFS)

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

    Measured: Up to approximately 5 years

  5. Overall survival (OS)

    It is defined as the time from the start of study treatment to the death from any cause

    Measured: Up to approximately 5 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 5 years

  7. Duration of Response (DoR)

    It is defined as the time from the first documentation of CRc to relapse

    Measured: Up to approximately 5 years

  8. 30-day postinduction mortality

    It is defined as death from any cause within 30 days after the start of induction

    Measured: Up to approximately 30 days

  9. 60-day postinduction mortality

    t is defined as death from any cause within 60 days after the start of induction

    Measured: Up to approximately 60 days

  10. Measurable Residual Disease (MRD) negative rate by flow cytometry

    Among those who have achieved CR/CRh/CRi after induction, proportion of patients who is MRD-negative by flow cytometry

    Measured: Up to approximately eight weeks

  11. Measurable Residual Disease (MRD) negative rate by molecular testing

    Among those who have achieved CR/CRh/CRi after induction, proportion of patients who is MRD-negative by molecular testing

    Measured: Up to approximately eight weeks

Timeline

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

  1. First posted18 Sep 2026
  2. Study start30 Oct 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2032 (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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07828535
Sponsor's protocol ID
IIT2026104
Status last verified
Aug 2026
First submitted
15 Sep 2026
Last updated
18 Sep 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 1 study testing Liposome Mitoxantrone, Venetoclax and Azacitidine in people with Acute Myeloid Leukemia (AML), run by Institute of Hematology & Blood Diseases Hospital, 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 11 inclusion and 11 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 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

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?

Dose-Limiting Toxicity (DLT) (time frame: Cycle 1(up to 42 days)). The study lists 3 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 NCT07828535.

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 18 Sep 2026.

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