Acute Myeloid Leukemia (AML)Phase 1/2NCT07486726
Aclarubicin Plus With Azacitidine and Venetoclax in the Treatment of Acute Myeloid Leukemia
A Phase 1/2 study testing Aclarubicin, Venetoclax and Azacitidine in people with Acute Myeloid Leukemia (AML) and Relapse Acute Myeloid Leukemia, run by Shanghai Jiao Tong University School of Medicine at 4 sites in China.
Trial summary
Acute myeloid leukemia Acute myeloid leukemia (AML) is a clonal hematopoietic cancer that disrupts normal hematopoiesis, ultimately leading to bone marrow failure and death. The annual incidence rate of AML is 4.1 per 100000 people in the US and is higher in patients older than 65 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia (AML), Relapse Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia (AML)
- What is being tested?
- Aclarubicin, Venetoclax and Azacitidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 4 sitesChina
- Study dates
- 15 Mar 2026to Oct 2028
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understand and voluntarily sign the informed consent form.
- Age 18 or above.
- Diagnosis (the diagnose is based on the 5th edition of the WHO classification of hematolymphoid tumors):
- Phase I cohort: Adults ≥18 years with newly diagnosed AML who's not a candidate for intensive chemotherapy (criteria include age ≥75, significant cardiac/pulmonary/hepatic/renal comorbidities, CGA assessment unfit for IC, etc.) or declines.
- Phase II cohort A: Adults ≥18 years with newly diagnosed AML who's not a candidate for intensive chemotherapy (criteria include age ≥75, significant cardiac/pulmonary/hepatic/renal comorbidities, CGA assessment unfit for IC, etc.) or declines.
- Phase II cohort B: Adults ≥18 years with relapsed/refractory AML after intensive chemotherapy (Exclude patients with FLT3 or IDH1/2 mutations who have not previously received targeted therapy).
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- Performance status < 3 (ECOG Scale).
- Estimated survival ≥ 3 months.
- White blood cell (WBC) count < 25 × 10^9 cells/L (hydroxyurea is permitted to control WBC count before treatment).
- Adequate liver and renal function as defined by the following criteria:
- Total serum bilirubin < 2.5 x upper limit of normal (ULN), unless due to Gilbert's syndrome, hemolysis or the underlying leukemia approved by the PI
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 2.5 x ULN, unless due to the underlying leukemia approved by the PI
- Creatinine clearance ≥50 mL/min
- Ability to swallow
- Phase II Cohort B: Subjects have recovered from prior treatment toxicity to less than Grade 2 (per CTCAE v6.0), excluding the influence of the underlying disease. The following are excluded: alopecia, fatigue, hyperpigmentation, hypothyroidism stabilized with hormone replacement therapy, and peripheral neuropathy following chemotherapy.
- Phase II Cohort B: Washout period from first dose of prior anti-cancer therapy
- at least 2 weeks after completion of cytotoxic chemotherapy
- at least 5 half-lives for non-cytotoxic drugs (if the 5 half-lives exceed 4 weeks, the washout period will still be calculated as 4 weeks). If the half-life is unclear, a washout period of >4 weeks will be considered
- at least 2 weeks after the first dose of anti-cancer traditional Chinese medicine.
- Subjects of reproductive potential must use effective contraceptive measures from the time they sign the informed consent form until 6 months after the last dose of the trial medication. Furthermore, male subjects of reproductive potential must refrain from sperm donation from the time they sign the informed consent form until 6 months after the last dose of the trial medication.
Who cannot join
- Prior therapies
- Phase I cohort: Patients with prior therapy are not eligible. Patients with a history of myeloproliferative disorders (MPNs), including primary myelofibrosis (PMF), polycythemia vera (PV), chronic myeloid leukemia (CML) excluding essential thrombocythemia (ET); or myelodysplasia-myeloproliferative neoplasms (MDS-MPNs), including chronic monocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), juvenile myelomonocytic leukemia (JMML), and acute promyelocytic leukemia (APL) are not eligible.
- Prior hydroxyurea or cytarabine given for purposes of cytoreduction is also allowed. Prior all trans-retinoic acid given for presumed acute promyelocytic leukemia is also allowed.
- Phase II cohort A: Same as for Phase I cohort.
- Phase II cohort B: Patients relapsed/refractory to prior lower intensity therapy for AML are not eligible. No restriction on number of prior therapies.
- Patients suitable for and willing to receive intensive induction chemotherapy (for Phase I and Phase II cohort A).
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- Congenital long QT syndrome or QTcF >450 msec (male), >470 msec (female). Repeat EKGs after correction of electrolytes or discontinuation of QT prolonging medications are allowed to meet entry criteria. In cases where QTcF >450/470 msec is considered to be falsely increased due to inaccurate automated reading and not clinically significant (e.g. due to bundle branch block), patients are still eligible if cardiologist reviews and documents that QTcF is ≤ 450 msec when manually measured.
- Active serious infection not controlled by systemic antibiotics (e.g. persistent fever or lack of improvement despite antimicrobial treatment).
- Active Grade III-V cardiac failure as defined by the New York Heart Association Criteria.
- Active central nervous system leukemia, extramedullary AML (except liver/spleen/lymph nodes)
- Known human immunodeficiency virus (HIV) seropositive. Known hepatitis B surface antigen seropositive or known or suspected active hepatitis C infection.
- Patients who have received an allo-HCT within 60 days of first receiving study medication must discontinue all immunosuppressants during study treatment.
- Patients who have previously received CAR-T therapy.
- Subjects with malabsorption syndrome or other comorbidities that prevent them from swallowing capsules or taking medications via the enteral route.
- Patients with a prior or concurrent malignancy whose natural history or treatment is not anticipated to interfere with the safety or efficacy assessment of the investigational regimen may be included only after discussion with the PI.
- Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry. Prior recent treatment with corticosteroids, hydroxyurea and/or cytarabine (given for cytoreduction) is permitted.
- Pregnant /lactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception throughout the study period and for at least 6 months after the last dose of study drugs. Women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 6 months. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control throughout the study period and for at least 6 months after the last dose of study drugs.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai
Shanghai
Yunxiang Zhang, +86-13564516004, zyx12103@rjh.com.cn
Shanghai Jing'an District Beizhan Hospital
Shanghai
Zhanyun Liu, lzy7706@126.com
Shanghai Traditional Chinese Medicine Hospital
Shanghai
Yuanfei Mao, morfycell@163.com
Tongren Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Li Yang, +8618017280986, 2512034560@qq.com
About this study
Official title: A Multicenter, Open-Label, Phase 1/2 Clinical Study of the Safety and Efficacy of Aclarubicin Combined With Azacitidine and Venetoclax in the Treatment of Acute Myeloid Leukemia
Acute myeloid leukemia Acute myeloid leukemia (AML) is a clonal hematopoietic cancer that disrupts normal hematopoiesis, ultimately leading to bone marrow failure and death. The annual incidence rate of AML is 4.1 per 100000 people in the US and is higher in patients older than 65 years. There has been a steady improvement in survival over the decades, more noticeably so in younger patients and in the last decade. Azacitidine and Venetoclax is now the standard treatment of newly diagnosed AML ineligible for intensive chemotherapy, while still facing the dilemma of relapse and refractory disease.
Anthracycline-based chemotherapeutics were wildly used in the treatment of fit AML patients. While the cardiovascular toxicity leading to morbidity and mortality limited the use of daunorubicin/idarubicin in unfit patients. Aclarubicin, also known as aclacinomycin A, is an anthracycline type of antibiotic with significant anti-cancer properties. Previous studies have shown that aclarubicin only induces histone eviction without causing DNA damage, and it stands out in pre-clinical models and clinical studies, as it potently kills AML cells. Meanwhile, aclarubicin lacks cardiotoxicity, and can be safely administered even after the maximum cumulative dose of either doxorubicin or idarubicin has been reached. CAG regimen, combined with low-dose cytarabine, aclarubicin and G-CSF has been widely used in China and Japan for treatment of AML.
The purpose of this study is to determine the maximum tolerated dose, safety and efficacy of aclarubicin combined with azacitidine and venetoclax for subjects with newly diagnosed and relapsed /refractory AML.
Read the detailed description
This will be a phase I/II, single-arm, open-label study. The study will have a phase I dose-escalation portion using a standard "3+3" approach to determine the MTD of aclarubicin in combination with established doses of azacitidine and venetoclax.
Phase I is open to patients with newly diagnosed AML who's not a candidate for, or refusal of intensive induction therapy. This will be followed by two parallel phase II expansion cohorts. Cohort A will enroll patients same as in phase I and Cohort B will enroll patients with relapsed/refractory AML after intensive chemotherapy.
The regimen consists of up to 6 cycles of the combination of azacitidine, venetoclax, and aclarubicin followed by maintenance azacitidine in none transplant cohort (up to 12 cycles). For patients eligible for allo-HCT, allo-HCT will be recommended, and the maintenance will be based on post-transplant schedule.
- Conditions
- Acute Myeloid Leukemia (AML), Relapse Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia (AML)
- Being tested
- Aclarubicin, Venetoclax, Azacitidine
- Keywords
- acute myeloid leukemia, Aclarubicin, ineligible for intensive chemotherapy, Azacitidine and Venetoclax
- 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.
AclarubicinDrug
Induction (Cycle1) Phase I starting dose 20mg/m^2 D1-D2 (dose group 1), 20mg/m2 D1-D3 (dose group 2), 20mg/m2 D1-D4 (dose group 3), ivgtt, Qd The Phase II dose was determined based on the Phase I results
Consolidation (Cycle 2-6) Phase I starting dose 20mg/m^2 D1-D2 (dose group 1), 20mg/m2 D1-D3 (dose group 2), 20mg/m2 D1-D4 (dose group 3), ivgtt, Qd The Phase II dose was determined based on the Phase I results
VenetoclaxDrug
Cycle 1 (Induction) 100mg on day 1, 200mg on day 2, 400mg on days 3-14
Cycles 2-6 (Consolidation) 400 mg orally daily on days 1-7
AzacitidineDrug
Cycle 1 (Induction) 75 mg/m^2 SC on days 1-7 of each cycle
Cycles 2-6 (Consolidation) 75 mg/m^2 SC on days 1-7 of each cycle
Cycles 7-18 (Maintenance) 50 mg/m^2 SC on days 1-5 of each cycle
| Study group | Role | What they receive |
|---|---|---|
| Aclarubicin + Venetoclax + Azacitidine | Experimental | Aclarubicin will be used in a dose escalation and dose expansion approach. Venetoclax and aclarubicin will be used in a fixed dose throughout the phases.
Phase I dose-escalation: a standard "3+3" approach for aclarubicin. Phase II: Cohort A will enroll patients same as in phase I and Cohort B will enroll patients with relapsed/refractory AML after intensive chemotherapy. Aclarubicin will be used at the dose determined by the dose escalation. Receives: Drug: Aclarubicin; Drug: Venetoclax; Drug: Azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
MTD for aclarubicin (primary outcome measure of phase I)
Measured: 28 days after first dose of aclarubicin
Recommended Phase 2 Dose (RP2D)
RP2D for aclarubicin (primary outcome measure of phase I)
Measured: 28 days after first dose of aclarubicin
Event-free survival (EFS)
primary outcome measure of phase II, cohort A
Measured: From date of enrollment until the date of induction treatment failure , relapse for patients who achieved induction treatment success, or death from any cause, whichever came first, assessed up to 24 months
Composite Complete Remission (CCR)
primary outcome measure of phase II, cohort B
Measured: Proportion of patients who achieved CR+CRi+CRh at the end of Cycle 2 (each cycle is 28 days)
Secondary outcomes (3)
Composite Complete Remission (CCR)
Preliminary efficacy assessment (secondary outcome measure of phase I). Proportion of patients who achieved CR+CRi+CRh.
Measured: Proportion of patients who achieved CR+CRi+CRh at the end of Cycle 2 (each cycle is 28 days)
Complete Remission Rate (CRR)
Preliminary efficacy assessment (secondary outcome measure of phase I). Proportion of patients who achieved CR.
Measured: Proportion of patients who achieved CR at the end of Cycle 2 (each cycle is 28 days)
Adverse Events
Number of participants with treatment-related adverse events as assessed by CTCAE v6.0
Measured: From enrollment through 28 days after the end of the last dose of aclarubicine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start15 Mar 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 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 Leukemia (AML)Studies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase I Primary Objectives: Evaluate safety and tolerability of aclarubicin + azacitidine + venetoclax in newly diagnosed AML patients unfit for intensive induction therapy. Phase II Primary Objectives: To determine the efficacy of the triplet regimen in two cohorts. Cohort A: newly diagnosed AML, who are unfit for, or who refuse, intensive induction therapy Cohort B: AML relapsed/refractory after intensive chemotherapy (Exclude patients with FLT3 or IDH1/2 mutations who have not previously received targeted therapy)
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center, Fred Hutchinson Cancer Center, Washington University School of Medicine
- Responsible party
- Principal investigator, Junmin Li, Shanghai Jiao Tong University School of Medicine
- Investigators
- Junmin Li, Professor, Principal investigator, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486726
- Sponsor's protocol ID
- AVAIL 2025
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Phase 1/2 Clinical Study of the Safety and Efficacy of Aclarubicin Combined With Azacitidine and Venetoclax in the Treatment of Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT07486726
- Acronym / sponsor ID
- AVAIL 2025
- Conditions
- Acute Myeloid Leukemia (AML), Relapse Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia (AML)
- Keywords
- acute myeloid leukemia, Aclarubicin, ineligible for intensive chemotherapy, Azacitidine and Venetoclax
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Leiden University Medical Center, Fred Hutchinson Cancer Center, Washington University School of Medicine
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 20 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.
Acute myeloid leukemia Acute myeloid leukemia (AML) is a clonal hematopoietic cancer that disrupts normal hematopoiesis, ultimately leading to bone marrow failure and death. The annual incidence rate of AML is 4.1 per 100000 people in the US and is higher in patients older than 65 years. There has been a steady improvement in survival over the decades, more noticeably so in younger patients and in the last decade. Azacitidine and Venetoclax is now the standard treatment of newly diagnosed AML ineligible for intensive chemotherapy, while still facing the dilemma of relapse and refractory disease.
Anthracycline-based chemotherapeutics were wildly used in the treatment of fit AML patients. While the cardiovascular toxicity leading to morbidity and mortality limited the use of daunorubicin/idarubicin in unfit patients. Aclarubicin, also known as aclacinomycin A, is an anthracycline type of antibiotic with significant anti-cancer properties. Previous studies have shown that aclarubicin only induces histone eviction without causing DNA damage, and it stands out in pre-clinical models and clinical studies, as it potently kills AML cells. Meanwhile, aclarubicin lacks cardiotoxicity, and can be safely administered even after the maximum cumulative dose of either doxorubicin or idarubicin has been reached. CAG regimen, combined with low-dose cytarabine, aclarubicin and G-CSF has been widely used in China and Japan for treatment of AML.
The purpose of this study is to determine the maximum tolerated dose, safety and efficacy of aclarubicin combined with azacitidine and venetoclax for subjects with newly diagnosed and relapsed /refractory AML.
Detailed description
This will be a phase I/II, single-arm, open-label study. The study will have a phase I dose-escalation portion using a standard "3+3" approach to determine the MTD of aclarubicin in combination with established doses of azacitidine and venetoclax.
Phase I is open to patients with newly diagnosed AML who's not a candidate for, or refusal of intensive induction therapy. This will be followed by two parallel phase II expansion cohorts. Cohort A will enroll patients same as in phase I and Cohort B will enroll patients with relapsed/refractory AML after intensive chemotherapy.
The regimen consists of up to 6 cycles of the combination of azacitidine, venetoclax, and aclarubicin followed by maintenance azacitidine in none transplant cohort (up to 12 cycles). For patients eligible for allo-HCT, allo-HCT will be recommended, and the maintenance will be based on post-transplant schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase I Primary Objectives: Evaluate safety and tolerability of aclarubicin + azacitidine + venetoclax in newly diagnosed AML patients unfit for intensive induction therapy. Phase II Primary Objectives: To determine the efficacy of the triplet regimen in two cohorts. Cohort A: newly diagnosed AML, who are unfit for, or who refuse, intensive induction therapy Cohort B: AML relapsed/refractory after intensive chemotherapy (Exclude patients with FLT3 or IDH1/2 mutations who have not previously received targeted therapy)
| Arm | Type | Receives |
|---|---|---|
| Aclarubicin + Venetoclax + Azacitidine | Experimental | Drug: Aclarubicin, Drug: Venetoclax, Drug: AzacitidineAclarubicin will be used in a dose escalation and dose expansion approach. Venetoclax and aclarubicin will be used in a fixed dose throughout the phases. Phase I dose-escalation: a standard "3+3" approach for aclarubicin. Phase II: Cohort A will enroll patients same as in phase I and Cohort B will enroll patients with relapsed/refractory AML after intensive chemotherapy. Aclarubicin will be used at the dose determined by the dose escalation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Understand and voluntarily sign the informed consent form.
- Age 18 or above.
- Diagnosis (the diagnose is based on the 5th edition of the WHO classification of hematolymphoid tumors):
- Performance status < 3 (ECOG Scale).
- Estimated survival ≥ 3 months.
Key exclusion criteria (17 listed)
- Prior therapies
- Prior hydroxyurea or cytarabine given for purposes of cytoreduction is also allowed. Prior all trans-retinoic acid given for presumed acute promyelocytic leukemia is also allowed.
- Patients suitable for and willing to receive intensive induction chemotherapy (for Phase I and Phase II cohort A).
- Congenital long QT syndrome or QTcF >450 msec (male), >470 msec (female). Repeat EKGs after correction of electrolytes or discontinuation of QT prolonging medications are allowed to meet entry criteria. In cases where QTcF >450/470 msec is considered to be falsely increased due to inaccurate automated reading and not clinically significant (e.g. due to bundle branch block), patients are still eligible if cardiologist reviews and documents that QTcF is ≤ 450 msec when manually measured.
- Active serious infection not controlled by systemic antibiotics (e.g. persistent fever or lack of improvement despite antimicrobial 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 |
|---|---|---|
| AclarubicinInduction (Cycle1) Phase I starting dose 20mg/m^2 D1-D2 (dose group 1), 20mg/m2 D1-D3 (dose group 2), 20mg/m2 D1-D4 (dose group 3), ivgtt, Qd The Phase II dose was determined based on the Phase I results Consolidation (Cycle 2-6) Phase I starting dose 20mg/m^2 D1-D2 (dose group 1), 20mg/m2 D1-D3 (dose group 2), 20mg/m2 D1-D4 (dose group 3), ivgtt, Qd The Phase II dose was determined based on the Phase I results | Drug | Aclarubicin + Venetoclax + Azacitidine |
| VenetoclaxCycle 1 (Induction) 100mg on day 1, 200mg on day 2, 400mg on days 3-14 Cycles 2-6 (Consolidation) 400 mg orally daily on days 1-7 | Drug | Aclarubicin + Venetoclax + Azacitidine |
| AzacitidineCycle 1 (Induction) 75 mg/m^2 SC on days 1-7 of each cycle Cycles 2-6 (Consolidation) 75 mg/m^2 SC on days 1-7 of each cycle Cycles 7-18 (Maintenance) 50 mg/m^2 SC on days 1-5 of each cycle | Drug | Aclarubicin + Venetoclax + Azacitidine |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: 28 days after first dose of aclarubicin
MTD for aclarubicin (primary outcome measure of phase I)
Recommended Phase 2 Dose (RP2D)
Time frame: 28 days after first dose of aclarubicin
RP2D for aclarubicin (primary outcome measure of phase I)
Event-free survival (EFS)
Time frame: From date of enrollment until the date of induction treatment failure , relapse for patients who achieved induction treatment success, or death from any cause, whichever came first, assessed up to 24 months
primary outcome measure of phase II, cohort A
Composite Complete Remission (CCR)
Time frame: Proportion of patients who achieved CR+CRi+CRh at the end of Cycle 2 (each cycle is 28 days)
primary outcome measure of phase II, cohort B
3 secondary outcomes
Composite Complete Remission (CCR)
Time frame: Proportion of patients who achieved CR+CRi+CRh at the end of Cycle 2 (each cycle is 28 days)
Complete Remission Rate (CRR)
Time frame: Proportion of patients who achieved CR at the end of Cycle 2 (each cycle is 28 days)
Adverse Events
Time frame: From enrollment through 28 days after the end of the last dose of aclarubicine
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 20 Mar 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.
Junmin Li, Professor principal investigator
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Aclarubicin, Venetoclax and Azacitidine in people with Acute Myeloid Leukemia (AML) and Relapse Acute Myeloid Leukemia, run by Shanghai Jiao Tong University School of Medicine at 4 sites 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 20 inclusion and 17 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 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 combined 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.
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 Yunxiang Zhang (+86-13564516004, zyx12103@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) (time frame: 28 days after first dose of aclarubicin). The study lists 4 primary outcomes in all. 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 20 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.