Acute Myeloid LeukemiaPhase 2NCT07028086
VAM in Secondary AML, AML With Extramedullary Involvement, and Myeloid Sarcoma
A Phase 2 study testing VAM_GROUP in people with Acute Myeloid Leukemia and Myeloid Sarcoma, run by Ruijin Hospital at 1 site in China.
Trial summary
The mitoxantrone liposomal enhances the tissue permeability of mitoxantrone by incorporating liposomal groups compared to the conventional mitoxantrone formulation, while also reducing the concentration of free mitoxantrone, thereby minimizing drug side effects-particularly cardiotoxicity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Myeloid Leukemia, Myeloid Sarcoma
- What is being tested?
- VAM_GROUP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2025to Apr 2028
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient fully understands this study, voluntarily participates, and signs the informed consent form (ICF)
- Age 18-65 years
- Clinically diagnosed, previously untreated acute myeloid leukemia (non-APL), meeting any one of the following criteria: a. Secondary acute myeloid leukemia; b. Therapy-related acute myeloid leukemia; c. AML with extramedullary/myeloid sarcoma; d. Age ≥60 years, assessed as fit-AML;
- Normal cardiac function, with left ventricular ejection fraction (LVEF) ≥50%
- Liver and kidney function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal (ULN) (≤5 times ULN for patients with liver involvement); total bilirubin ≤1.5 times ULN; serum creatinine ≤1.5 times ULN
- Eastern Cooperative Oncology Group (ECOG) performance status score: 0-2
Who cannot join
- Assessed as unfit- or frail-AML;
- Patients with a history or concurrent diagnosis of other malignancies requiring treatment
- Uncontrolled systemic diseases (e.g., advanced active infections, uncontrolled hypertension, etc.)
- Known history of immediate or delayed hypersensitivity reactions to the same class of study drugs or excipients
- Pregnant or breastfeeding women, or patients who refuse to use effective contraception during the study period
- Patients with a history of severe neurological or psychiatric disorders
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- Other severe medical conditions, such as myocardial infarction, severe or unstable angina, severe arrhythmias
- Cerebrovascular events (including transient ischemic attacks), etc.
- Known infection with human immunodeficiency virus (HIV); active hepatitis B or C infection; inactive hepatitis carriers or subjects with low viral titers after receiving non-prohibited antiviral therapy are not excluded
- Subjects who have received strong or moderate CYP3A inducers/inhibitors or strong P-gp inhibitors or related foods within 7 days before starting the study treatment
- Patients unable to take oral medications or with malabsorption syndrome
- Patients deemed by the investigator to be unsuitable for participation in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
Yang Shen, +86-021-64370045, sy_clinicaltrial@163.com
About this study
Official title: Prospective, Multicenter, Single-Arm Clinical Study of Mitoxantrone Liposome Combined With Azacitidine and Venetoclax in the Treatment of Secondary AML, AML With Extramedullary Involvement, and Myeloid Sarcoma
The mitoxantrone liposomal enhances the tissue permeability of mitoxantrone by incorporating liposomal groups compared to the conventional mitoxantrone formulation, while also reducing the concentration of free mitoxantrone, thereby minimizing drug side effects-particularly cardiotoxicity.
Building upon this, the investigators aim to investigate the efficacy and safety of the liposomal mitoxantrone hydrochloride injection in patients with secondary AML, AML with extramedullary involvement, or myeloid sarcoma, in order to explore alternative therapeutic strategies for these populations.
- Conditions
- Acute Myeloid Leukemia, Myeloid Sarcoma
- Being tested
- VAM_GROUP
- Keywords
- Secondary AML, AML with Extramedullary Involvement, Myeloid Sarcoma
- Medical subject headings
- Leukemia, Myeloid, Acute, Sarcoma, Myeloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAM_GROUPDrug
Mitoxantrone Liposome 24mg/m², IV, administered as a single dose or divided doses at the investigator's discretion based on the patient's condition; Azacitidine 75mg/m², IV drip, Day 1 to Day 7; Venetoclax 100mg on Day 1, 200mg on Day 2, and 400mg on Day 3 to Day 14.
| Study group | Role | What they receive |
|---|---|---|
| MAVEN_GROUP | Experimental | Not described Receives: Drug: VAM_GROUP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Complete Remission Rate
Measured: After completing two cycles (each cycle is 28 days) of VAM therapy
Secondary outcomes (3)
Event-Free Survival
Measured: from data of AML diagnosis until the data of events, assessed up to 2 years
Overall Survival
Measured: from enrollment to study completion, a maximum of 2 years
Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: During the two cycles (each cycle is 28 days) of VAM therapy and follow-up for 2 years after completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start20 Jun 2025
- Primary completionJun 2026 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen yang, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028086
- Sponsor's protocol ID
- MAVEN_01
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Single-Arm Clinical Study of Mitoxantrone Liposome Combined With Azacitidine and Venetoclax in the Treatment of Secondary AML, AML With Extramedullary Involvement, and Myeloid Sarcoma
- ClinicalTrials.gov ID
- NCT07028086
- Acronym / sponsor ID
- MAVEN_01
- Conditions
- Acute Myeloid Leukemia, Myeloid Sarcoma
- Keywords
- Secondary AML, AML with Extramedullary Involvement, Myeloid Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The mitoxantrone liposomal enhances the tissue permeability of mitoxantrone by incorporating liposomal groups compared to the conventional mitoxantrone formulation, while also reducing the concentration of free mitoxantrone, thereby minimizing drug side effects-particularly cardiotoxicity.
Building upon this, the investigators aim to investigate the efficacy and safety of the liposomal mitoxantrone hydrochloride injection in patients with secondary AML, AML with extramedullary involvement, or myeloid sarcoma, in order to explore alternative therapeutic strategies for these populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MAVEN_GROUP | Experimental | Drug: VAM_GROUP |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patient fully understands this study, voluntarily participates, and signs the informed consent form (ICF)
- Age 18-65 years
- Clinically diagnosed, previously untreated acute myeloid leukemia (non-APL), meeting any one of the following criteria: a. Secondary acute myeloid leukemia; b. Therapy-related acute myeloid leukemia; c. AML with extramedullary/myeloid sarcoma; d. Age ≥60 years, assessed as fit-AML;
- Normal cardiac function, with left ventricular ejection fraction (LVEF) ≥50%
- Liver and kidney function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal (ULN) (≤5 times ULN for patients with liver involvement); total bilirubin ≤1.5 times ULN; serum creatinine ≤1.5 times ULN
Key exclusion criteria (12 listed)
- Assessed as unfit- or frail-AML;
- Patients with a history or concurrent diagnosis of other malignancies requiring treatment
- Uncontrolled systemic diseases (e.g., advanced active infections, uncontrolled hypertension, etc.)
- Known history of immediate or delayed hypersensitivity reactions to the same class of study drugs or excipients
- Pregnant or breastfeeding women, or patients who refuse to use effective contraception during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VAM_GROUPMitoxantrone Liposome 24mg/m², IV, administered as a single dose or divided doses at the investigator's discretion based on the patient's condition; Azacitidine 75mg/m², IV drip, Day 1 to Day 7; Venetoclax 100mg on Day 1, 200mg on Day 2, and 400mg on Day 3 to Day 14. | Drug | MAVEN_GROUP |
Primary outcome
Composite Complete Remission Rate
Time frame: After completing two cycles (each cycle is 28 days) of VAM therapy
3 secondary outcomes
Event-Free Survival
Time frame: from data of AML diagnosis until the data of events, assessed up to 2 years
Overall Survival
Time frame: from enrollment to study completion, a maximum of 2 years
Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: During the two cycles (each cycle is 28 days) of VAM therapy and follow-up for 2 years after completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VAM_GROUP in people with Acute Myeloid Leukemia and Myeloid Sarcoma, run by Ruijin Hospital 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 6 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 9 Jul 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Complete Remission Rate (time frame: After completing two cycles (each cycle is 28 days) of VAM therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2025.