AMLNCT07490288
Venetoclax, Azacitidine and Liposomal Mitoxantrone for Newly Diagnosed AML
A study testing Venetoclax, Azacitidine and Liposomal Mitoxantrone in people with AML, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
This is a single-arm, open-label clinical trial evaluating the safety and preliminary efficacy of a novel induction regimen combining Venetoclax, Azacitidine, and Liposomal Mitoxantrone (VAM) in patients with newly diagnosed Acute Myeloid Leukemia (AML) who are eligible for intensive chemotherapy. Read more about this study
- Who is it for?
- Ages 14 to 100 years
- Conditions the study is for
- AML
- What is being tested?
- Venetoclax, Azacitidine and Liposomal Mitoxantrone
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2026to 1 Mar 2029
- Phase
- Interventional
- 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 14 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed with AML according to the WHO (2022) or ICC criteria, or with MDS/AML as defined by ICC (with 10%-20% blasts in the bone marrow)
- Age ≥ 14 years, male or female.
- Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2.
- Meet the following laboratory requirements (tests must be performed within 7 days prior to treatment):
- Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) for the corresponding age group.
- AST and ALT ≤ 2.5 times ULN for the corresponding age group. iii. Serum creatinine < 1.5 times ULN for the corresponding age group. iv. Cardiac enzymes < 2 times ULN for the corresponding age group. v. Left ventricular ejection fraction (LVEF) within the normal range as measured by echocardiography (ECHO).
Who cannot join
- Acute promyelocytic leukemia with PML::RARA fusion gene.
- Acute myeloid leukemia with RUNX1::RUNX1T1 fusion gene.
- Acute myeloid leukemia with BCR::ABL1 fusion gene.
- Previously treated patients (defined as having received prior induction chemotherapy for AML/MDS; prior use of cytoreductive agents like hydroxyurea is allowed).
- Concurrent active malignancy of other organs (requiring treatment).
- Active cardiac disease, defined as one or more of the following:
Show all 10Show fewer
- History of uncontrolled or symptomatic angina. ii. Myocardial infarction within 6 months prior to study enrollment. iii. History of clinically significant arrhythmia requiring medication or causing severe symptoms.
- Uncontrolled or symptomatic congestive heart failure (> New York Heart Association [NYHA] Class 2).
- Active, uncontrolled infectious diseases (e.g., untreated tuberculosis, pulmonary aspergillosis).
- Any other condition that, in the opinion of the investigator, makes the patient unsuitable for study participation.
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
Blood diseases hospital
Tianjin, Tianjin Municipality, 300020
Hui Wei, 022-23608456, weihui@ihcams.ac.cn
About this study
Official title: A Single-Arm, Open-Label Study of Venetoclax, Azacitidine, and Liposomal Mitoxantrone (VAM) as Induction Therapy in Newly-diagnosed Adult Patients With Acute Myeloid Leukemia (AML)
This is a single-arm, open-label clinical trial evaluating the safety and preliminary efficacy of a novel induction regimen combining Venetoclax, Azacitidine, and Liposomal Mitoxantrone (VAM) in patients with newly diagnosed Acute Myeloid Leukemia (AML) who are eligible for intensive chemotherapy.
The study plans to enroll 27 participants. Patients will receive VAM induction therapy, followed by three cycles of intermediate-dose cytarabine consolidation. Allogeneic hematopoietic stem cell transplantation is recommended for high-risk or MRD-positive patients in remission.
- Conditions
- AML
- Being tested
- Venetoclax, Azacitidine, Liposomal Mitoxantrone, Cytarabine, Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenetoclaxDrug
BCL-2 inhibitor. Oral. Induction: 100 mg day 1, 200 mg day 2, then 400 mg days 3-14.
AzacitidineDrug
Hypomethylating agent. 75 mg/m²/day IV/SC on days 1-7 of induction.
Liposomal MitoxantroneDrug
Liposomal topoisomerase II inhibitor. 24 mg/m² IV on day 1 of each induction cycle.
CytarabineDrug
Antimetabolite. Consolidation: 2 g/m² (age <60) or 1 g/m² (age ≥60) q12h IV on days 1-3 for 3 cycles.
Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)Procedure or surgery
Recommended for high-risk or MRD+ patients after response.
| Study group | Role | What they receive |
|---|---|---|
| VAM Induction Regimen | Experimental | Single-arm study evaluating venetoclax, azacitidine, and liposomal mitoxantrone (VAM) as induction in newly diagnosed AML patients fit for intensive chemotherapy. Patients receive 1-2 cycles of VAM induction, followed by 3 cycles of intermediate-dose cytarabine consolidation. High-risk or MRD+ patients may proceed to allogeneic HSCT. Receives: Drug: Venetoclax; Drug: Azacitidine; Drug: Liposomal Mitoxantrone; Drug: Cytarabine; Procedure: Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete remission rate after induction
Measured: up to 84 days
Secondary outcomes (9)
Event-free survival
Measured: Up to 2 years
Overall survival
Measured: Up to 5 years
Relapse-free survival
Measured: Up to 5 years
MRD negativity rate by flow cytometry after 1 induction cycle
Measured: At the end of the first and second induction cycles
MRD negativity rate by flow cytometry after 2 induction cycles
Measured: At the end of the first and second induction cycles
30-day mortality
Measured: up to 30 days
60-day mortality
Measured: up to 60 days
MRD negativity rate by NGS OR PCR after 1 induction cycle
Measured: up to 42 days
MRD negativity rate by NGS OR PCR after 2 induction cycles
Measured: up to 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start8 May 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMLStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490288
- Sponsor's protocol ID
- IIT2026021
- Status last verified
- Aug 2026
- First submitted
- 26 Feb 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Label Study of Venetoclax, Azacitidine, and Liposomal Mitoxantrone (VAM) as Induction Therapy in Newly-diagnosed Adult Patients With Acute Myeloid Leukemia (AML)
- ClinicalTrials.gov ID
- NCT07490288
- Acronym / sponsor ID
- IIT2026021
- Conditions
- AML
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 8 May 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 24 Mar 2026 (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.
This is a single-arm, open-label clinical trial evaluating the safety and preliminary efficacy of a novel induction regimen combining Venetoclax, Azacitidine, and Liposomal Mitoxantrone (VAM) in patients with newly diagnosed Acute Myeloid Leukemia (AML) who are eligible for intensive chemotherapy.
The study plans to enroll 27 participants. Patients will receive VAM induction therapy, followed by three cycles of intermediate-dose cytarabine consolidation. Allogeneic hematopoietic stem cell transplantation is recommended for high-risk or MRD-positive patients in remission.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VAM Induction Regimen | Experimental | Drug: Venetoclax, Drug: Azacitidine, Drug: Liposomal Mitoxantrone, Drug: Cytarabine, Procedure: Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)Single-arm study evaluating venetoclax, azacitidine, and liposomal mitoxantrone (VAM) as induction in newly diagnosed AML patients fit for intensive chemotherapy. Patients receive 1-2 cycles of VAM induction, followed by 3 cycles of intermediate-dose cytarabine consolidation. High-risk or MRD+ patients may proceed to allogeneic HSCT. |
Who may qualify
- Ages
- 14 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients diagnosed with AML according to the WHO (2022) or ICC criteria, or with MDS/AML as defined by ICC (with 10%-20% blasts in the bone marrow)
- Age ≥ 14 years, male or female.
- Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2.
- Meet the following laboratory requirements (tests must be performed within 7 days prior to treatment):
- AST and ALT ≤ 2.5 times ULN for the corresponding age group. iii. Serum creatinine < 1.5 times ULN for the corresponding age group. iv. Cardiac enzymes < 2 times ULN for the corresponding age group. v. Left ventricular ejection fraction (LVEF) within the normal range as measured by echocardiography (ECHO).
Key exclusion criteria (10 listed)
- Acute promyelocytic leukemia with PML::RARA fusion gene.
- Acute myeloid leukemia with RUNX1::RUNX1T1 fusion gene.
- Acute myeloid leukemia with BCR::ABL1 fusion gene.
- Previously treated patients (defined as having received prior induction chemotherapy for AML/MDS; prior use of cytoreductive agents like hydroxyurea is allowed).
- Concurrent active malignancy of other organs (requiring treatment).
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 |
|---|---|---|
| VenetoclaxBCL-2 inhibitor. Oral. Induction: 100 mg day 1, 200 mg day 2, then 400 mg days 3-14. | Drug | VAM Induction Regimen |
| AzacitidineHypomethylating agent. 75 mg/m²/day IV/SC on days 1-7 of induction. | Drug | VAM Induction Regimen |
| Liposomal MitoxantroneLiposomal topoisomerase II inhibitor. 24 mg/m² IV on day 1 of each induction cycle. | Drug | VAM Induction Regimen |
| CytarabineAntimetabolite. Consolidation: 2 g/m² (age <60) or 1 g/m² (age ≥60) q12h IV on days 1-3 for 3 cycles. | Drug | VAM Induction Regimen |
| Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)Recommended for high-risk or MRD+ patients after response. | Procedure or surgery | VAM Induction Regimen |
Primary outcome
complete remission rate after induction
Time frame: up to 84 days
9 secondary outcomes
Event-free survival
Time frame: Up to 2 years
Overall survival
Time frame: Up to 5 years
Relapse-free survival
Time frame: Up to 5 years
MRD negativity rate by flow cytometry after 1 induction cycle
Time frame: At the end of the first and second induction cycles
MRD negativity rate by flow cytometry after 2 induction cycles
Time frame: At the end of the first and second induction cycles
30-day mortality
Time frame: up to 30 days
60-day mortality
Time frame: up to 60 days
MRD negativity rate by NGS OR PCR after 1 induction cycle
Time frame: up to 42 days
MRD negativity rate by NGS OR PCR after 2 induction cycles
Time frame: up to 84 days
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 7 Aug 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venetoclax, Azacitidine and Liposomal Mitoxantrone in people with AML, 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 6 inclusion and 10 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 7 Aug 2026. 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?
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 Hui Wei, MD (13132507161, weihui@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete remission rate after induction (time frame: up to 84 days). 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 7 Aug 2026.