Acute Myeloid Leukemia (AML)Phase 2NCT07754799
A Randomized Trial of Venetoclax-Based Induction Intensity in Newly Diagnosed Acute Myeloid Leukemia
A Phase 2 study testing Daunorubicin, Cytarabine and Liposome Mitoxantrone in people with Acute Myeloid Leukemia (AML), run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
This randomized, open label, multi arm phase II trial will evaluate the efficacy and safety of venetoclax based induction regimens of varying intensity (VA, VAM, or 2+5+V) versus standard 3+7 in fit patients aged ≥14 years with newly diagnosed AML. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Acute Myeloid Leukemia (AML)
- What is being tested?
- Daunorubicin, Cytarabine and Liposome Mitoxantrone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 30 Sep 2029
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of AML per WHO (2022) or ICC criteria, and MDS/AML as defined by ICC (with bone marrow blast percentage of 10%-20%).
- Age ≥14 years, male or female.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Judged by the investigator to be suitable for intensive induction chemotherapy and expected to tolerate the treatment intensity specified in the protocol.
- Meet the following laboratory test requirements (assessed within 7 days prior to treatment):
- Total bilirubin ≤1.5 × upper limit of normal (ULN) for the same age group;
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- AST and ALT ≤2.5 × ULN for the same age group;
- Serum creatinine <2 × ULN for the same age group;
- Cardiac enzymes <2 × ULN for the same age group;
- Cardiac ejection fraction determined by echocardiography (ECHO) within the normal range.
- Written informed consent must be signed before any study specific procedures are initiated, by the patient themselves or by their immediate family members. If, in consideration of the patient's medical condition, signing by the patient themselves would be detrimental to their treatment, the informed consent may be signed by the legally authorized representative or the patient's immediate family members.
Who cannot join
- Acute promyelocytic leukemia with PML-RARA fusion gene.
- Acute myeloid leukemia with RUNX1-RUNX1T1 or CBFB-MYH11 fusion gene.
- Acute myeloid leukemia with BCR-ABL fusion gene.
- Presence of FLT3 mutation (these patients are recommended to be enrolled in clinical trials of FLT3 inhibitors).
- Patients who have previously received induction chemotherapy (however, cytoreductive therapy such as hydroxyurea is permitted).
- Concurrent malignancy of other organs that requires treatment.
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- Active cardiac disease, defined as one or more of the following:
- History of uncontrolled or symptomatic angina pectoris;
- Myocardial infarction within 6 months prior to study enrollment;
- History of arrhythmia requiring medication or with clinically significant symptoms;
- Uncontrolled or symptomatic congestive heart failure (> NYHA class 2).
- Serious infectious diseases (e.g., active tuberculosis, pulmonary aspergillosis).
- Patients deemed unsuitable for enrollment by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: VISTA-AML- Venetoclax Intensity Selection Trial in AML: A Randomized Phase II Selection Trial of Venetoclax-Based Induction Intensity in Newly Diagnosed Acute Myeloid Leukemia
This randomized, open label, multi arm phase II trial will evaluate the efficacy and safety of venetoclax based induction regimens of varying intensity (VA, VAM, or 2+5+V) versus standard 3+7 in fit patients aged ≥14 years with newly diagnosed AML. The trial is designed to select the optimal regimen as the experimental arm for a subsequent phase III randomized controlled trial.
A total of 320 patients will be enrolled in this study，and segregated into four groups with 80 in each group. Patients who achieve CR/CRi/CRh after using different induction regimens will receive the same consolidation. Allogeneic hematopoietic stem cell transplantation is recommended for patients in the high-risk group or those with persist MRD positivity. After completion of the treatment phase, patients entered the follow-up period.
- Conditions
- Acute Myeloid Leukemia (AML)
- Being tested
- Daunorubicin, Cytarabine, 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.
DaunorubicinDrug
daunorubicin: 60 mg/m2, administered by intravenous drip (ivgtt) on days 1-3,
CytarabineDrug
Cytarabine: 100 mg/m2, administered by intravenous drip (ivgtt) on days 1-7,
Liposome MitoxantroneDrug
Liposome Mitoxantrone: 24 mg/m², administered by intravenous drip (ivgtt) on day 1,
VenetoclaxDrug
Venetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3-14, administered orally (po),
AzacitidineDrug
Azacitidine: 75 mg/m², administered subcutaneously (sc) on days 1-7,
VenetoclaxDrug
Venetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3-21, administered orally (po). Bone marrow examination is performed on day 21. If blasts >5%, then venetoclax 400 mg is continued on days 21-28.
DaunorubicinDrug
daunorubicin: 60 mg/m2, administered by intravenous drip (ivgtt) on days 1-2,
CytarabineDrug
Cytarabine: 100 mg/m2, administered by intravenous drip (ivgtt) on days 1-5,
VenetoclaxDrug
Venetoclax: 100 mg on day 3, 200 mg on day 4, and 400 mg on days 5-11, administered orally (po),
| Study group | Role | What they receive |
|---|---|---|
| 3+7 | Active comparator | Drug: daunorubicin daunorubicin: 60 mg/m2, administered by intravenous drip (ivgtt) on days 1-3, Drug: Cytarabine Cytarabine: 100 mg/m2, administered by intravenous drip (ivgtt) on days 1-7, Receives: Drug: Daunorubicin; Drug: Cytarabine |
| VAM | Experimental | Drug: Liposome Mitoxantrone Liposome Mitoxantrone: 24 mg/m², administered by intravenous drip (ivgtt) on day 1, every 4 weeks Drug: Venetoclax Venetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3-14, administered orally (po), every 4 weeks Drug: Azacitidine Azacitidine: 75 mg/m², administered subcutaneously (sc) on days 1-7, Receives: Drug: Liposome Mitoxantrone; Drug: Venetoclax; Drug: Azacitidine |
| VA | Experimental | Drug: Venetoclax Venetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3-21, administered orally (po). Bone marrow examination is performed on day 21. If blasts >5%, then venetoclax 400 mg is continued on days 21-28.
Drug: Azacitidine Azacitidine: 75 mg/m², administered subcutaneously (sc) on days 1-7, Receives: Drug: Azacitidine; Drug: Venetoclax |
| 2+5+V | Experimental | Drug: daunorubicin daunorubicin: 60 mg/m2, administered by intravenous drip (ivgtt) on days 1-2, every 4 weeks Drug: Cytarabine Cytarabine: 100 mg/m2, administered by intravenous drip (ivgtt) on days 1-5, every 4 weeks Drug: Venetoclax Venetoclax: 100 mg on day 3, 200 mg on day 4, and 400 mg on days 5-11, administered orally (po) Receives: Drug: Daunorubicin; Drug: Cytarabine; Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 3 years
Secondary outcomes (9)
30-day postinduction mortality
It is defined as death from any cause within 30 days after the start of induction.
Measured: up to 30 days
60-day postinduction mortality
It is defined as death from any cause within 60 days after the start of induction.
Measured: Up to 60 days
Composite complete remission (CRc) rate
Proportion of patients with complete remission (CR), complete remission with partial hematologic recovery (CRh) or complete remission with incomplete hematologic recovery (CRi).
Measured: Up to eight weeks
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 eight weeks
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
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 3 years
Overall survival (OS)
It is defined as the time from the start of randomization to the death from any cause.
Measured: Up to 3 years
Cumulative incidence of relapse (CIR)
It is defined as the time from the start of achieving remission to hematologic relapse.
Measured: Up to 3 years
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia (AML)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754799
- Sponsor's protocol ID
- IIT2026079
- Status last verified
- Jul 2026
- First submitted
- 5 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VISTA-AML- Venetoclax Intensity Selection Trial in AML: A Randomized Phase II Selection Trial of Venetoclax-Based Induction Intensity in Newly Diagnosed Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT07754799
- Acronym / sponsor ID
- IIT2026079
- Conditions
- Acute Myeloid Leukemia (AML)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 10 Aug 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 randomized, open label, multi arm phase II trial will evaluate the efficacy and safety of venetoclax based induction regimens of varying intensity (VA, VAM, or 2+5+V) versus standard 3+7 in fit patients aged ≥14 years with newly diagnosed AML. The trial is designed to select the optimal regimen as the experimental arm for a subsequent phase III randomized controlled trial.
A total of 320 patients will be enrolled in this study，and segregated into four groups with 80 in each group. Patients who achieve CR/CRi/CRh after using different induction regimens will receive the same consolidation. Allogeneic hematopoietic stem cell transplantation is recommended for patients in the high-risk group or those with persist MRD positivity. After completion of the treatment phase, patients entered the follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 3+7 | Active comparator | Drug: Daunorubicin, Drug: CytarabineDrug: daunorubicin daunorubicin: 60 mg/m2, administered by intravenous drip (ivgtt) on days 1-3, Drug: Cytarabine Cytarabine: 100 mg/m2, administered by intravenous drip (ivgtt) on days 1-7, |
| VAM | Experimental | Drug: Liposome Mitoxantrone, Drug: Venetoclax, Drug: AzacitidineDrug: Liposome Mitoxantrone Liposome Mitoxantrone: 24 mg/m², administered by intravenous drip (ivgtt) on day 1, every 4 weeks Drug: Venetoclax Venetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3-14, administered orally (po), every 4 weeks Drug: Azacitidine Azacitidine: 75 mg/m², administered subcutaneously (sc) on days 1-7, |
| VA | Experimental | Drug: Azacitidine, Drug: VenetoclaxDrug: Venetoclax Venetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3-21, administered orally (po). Bone marrow examination is performed on day 21. If blasts >5%, then venetoclax 400 mg is continued on days 21-28. Drug: Azacitidine Azacitidine: 75 mg/m², administered subcutaneously (sc) on days 1-7, |
| 2+5+V | Experimental | Drug: Daunorubicin, Drug: Cytarabine, Drug: VenetoclaxDrug: daunorubicin daunorubicin: 60 mg/m2, administered by intravenous drip (ivgtt) on days 1-2, every 4 weeks Drug: Cytarabine Cytarabine: 100 mg/m2, administered by intravenous drip (ivgtt) on days 1-5, every 4 weeks Drug: Venetoclax Venetoclax: 100 mg on day 3, 200 mg on day 4, and 400 mg on days 5-11, administered orally (po) |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosis of AML per WHO (2022) or ICC criteria, and MDS/AML as defined by ICC (with bone marrow blast percentage of 10%-20%).
- Age ≥14 years, male or female.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Judged by the investigator to be suitable for intensive induction chemotherapy and expected to tolerate the treatment intensity specified in the protocol.
- Meet the following laboratory test requirements (assessed within 7 days prior to treatment):
Key exclusion criteria (13 listed)
- Acute promyelocytic leukemia with PML-RARA fusion gene.
- Acute myeloid leukemia with RUNX1-RUNX1T1 or CBFB-MYH11 fusion gene.
- Acute myeloid leukemia with BCR-ABL fusion gene.
- Presence of FLT3 mutation (these patients are recommended to be enrolled in clinical trials of FLT3 inhibitors).
- Patients who have previously received induction chemotherapy (however, cytoreductive therapy such as hydroxyurea is permitted).
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 |
|---|---|---|
| Daunorubicindaunorubicin: 60 mg/m2, administered by intravenous drip (ivgtt) on days 1-3, | Drug | 3+7 |
| CytarabineCytarabine: 100 mg/m2, administered by intravenous drip (ivgtt) on days 1-7, | Drug | 3+7 |
| Liposome MitoxantroneLiposome Mitoxantrone: 24 mg/m², administered by intravenous drip (ivgtt) on day 1, | Drug | VAM |
| VenetoclaxVenetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3-14, administered orally (po), | Drug | VAM |
| AzacitidineAzacitidine: 75 mg/m², administered subcutaneously (sc) on days 1-7, | Drug | VA, VAM |
| VenetoclaxVenetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3-21, administered orally (po). Bone marrow examination is performed on day 21. If blasts >5%, then venetoclax 400 mg is continued on days 21-28. | Drug | VA |
| Daunorubicindaunorubicin: 60 mg/m2, administered by intravenous drip (ivgtt) on days 1-2, | Drug | 2+5+V |
| CytarabineCytarabine: 100 mg/m2, administered by intravenous drip (ivgtt) on days 1-5, | Drug | 2+5+V |
| VenetoclaxVenetoclax: 100 mg on day 3, 200 mg on day 4, and 400 mg on days 5-11, administered orally (po), | Drug | 2+5+V |
Primary outcome
Event-free survival (EFS)
Time frame: up to 3 years
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).
9 secondary outcomes
30-day postinduction mortality
Time frame: up to 30 days
60-day postinduction mortality
Time frame: Up to 60 days
Composite complete remission (CRc) rate
Time frame: Up to eight weeks
Measurable Residual Disease (MRD) negative rate by flow cytometry
Time frame: Up to eight weeks
Measurable Residual Disease (MRD) negative rate by molecular testing
Time frame: Up to approximately eight weeks
Relapse-free Survival (RFS)
Time frame: Up to 3 years
Overall survival (OS)
Time frame: Up to 3 years
Cumulative incidence of relapse (CIR)
Time frame: Up to 3 years
Incidence of treatment related adverse events
Time frame: From day 1 of treatment to 28 days after the last dose
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 26 Aug 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Daunorubicin, Cytarabine and Liposome Mitoxantrone 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 13 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 26 Aug 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 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?
Contact Hui Wei, MD (022-23608456, weihui@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival (EFS) (time frame: up to 3 years). 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 26 Aug 2026.