Newly Diagnosed Acute Myeloid Leukemia (AML)Phase 3NCT07514936
Venetoclax-Azacitidine in Combination With Chidamide and CAG in Fit Older Patients With Acute Myeloid Leukaemia
A Phase 3 study testing the standard "3+7" regimen and Azacytidine; Cytarabine; Aclacinomycin; Chidamide; Venetoclax; Granulocyte in people with Newly Diagnosed Acute Myeloid Leukemia (AML) and Elderly Patients, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
This study is a multicenter, prospective, randomized, controlled clinical trial, observing the efficacy and safety of the CACAG+Venetoclax regimen (Chidamide + Azacitidine + Aclarubicin + Cytarabine + Recombinant Human Granulocyte Colony-Stimulating Factor + Venetoclax) in elderly patients with newly diagnosed Acute… Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Newly Diagnosed Acute Myeloid Leukemia (AML), Elderly Patients
- What is being tested?
- the standard "3+7" regimen and Azacytidine; Cytarabine; Aclacinomycin; Chidamide; Venetoclax; Granulocyte
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 18 Nov 2024to 31 Dec 2027
- Phase
- Phase 3
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary participation in the clinical study; the subject or legal guardian fully understands and is informed about the study and has signed the Informed Consent Form (ICF); willing to follow and able to complete all trial procedures;
- Age between 60-75 years at the time of screening, with no gender restrictions;
- Patients are newly diagnosed with AML, and the diagnosis conforms to the standards of the Chinese Medical Association 2021 edition;
- No severe allergic constitution;
- Liver function: ALT and AST <= 2.5 times the upper limit of normal values, bilirubin <= 2 times the upper limit of normal values;
- Renal function: creatinine <= upper limit of normal values;
- No uncontrollable infections or severe mental illnesses;
- Performance status score is 0-3 (ECOG), with an expected survival of at least 4 months.
Who cannot join
- Patients who are allergic to the study medication or have contraindications to it;
- Pregnant or breastfeeding women;
- Patients with active infections;
- Patients with long-term smoking or alcohol abuse that could affect the evaluation of trial results;
- Patients with mental disorders or other conditions that prevent obtaining informed consent, or who are unable to cooperate with the treatment and examination procedures;
- Patients who have undergone major organ surgery within the last 6 weeks;
- Abnormal liver function, with total bilirubin > 1.5 times the upper limit of normal, ALT/AST > 2.5 times the upper limit of normal, or liver-infiltrated patients with ALT/AST > 5 times the upper limit of normal; abnormal renal function, with serum creatinine > 1.5 times the upper limit of normal;
- Patients whom the investigator deems unsuitable for this clinical trial (e.g., poor compliance, drug abuse, etc.).
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
Chinese PLA General Hospital
Beijing, None Selected, 100853
Liping Dou, +8613681207138, lipingruirui@163.com
About this study
Official title: Venetoclax-Azacitidine in Combination With Chidamide and CAG Versus 3+7 Regimen in Fit Older Patients With Acute Myeloid Leukaemia：A Multicenter, Randomized, Controlled, Phase 3 Trial
This study is a multicenter, prospective, randomized, controlled clinical trial, observing the efficacy and safety of the CACAG+Venetoclax regimen (Chidamide + Azacitidine + Aclarubicin + Cytarabine + Recombinant Human Granulocyte Colony-Stimulating Factor + Venetoclax) in elderly patients with newly diagnosed Acute Myeloid Leukemia (AML). The control group applies the standard "3+7" regimen. The aim is to improve the remission rate of AML patients, reduce the probability of adverse events, and thereby improve patient prognosis and extend patient survival.
- Being tested
- the standard "3+7" regimen, Azacytidine; Cytarabine; Aclacinomycin; Chidamide; Venetoclax; Granulocyte
- Keywords
- Elderly Patients, newly diagnosed, Acute Myeloid Leukemia
- 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.
the standard "3+7" regimenDrug
IA Regimen:
Idarubicin: 8-12 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7.
Or DA Regimen:
Daunorubicin: 60 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7.
Or MA Regimen:
Mitoxantrone: 6-10 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7.
Azacytidine; Cytarabine; Aclacinomycin; Chidamide; Venetoclax; GranulocyteDrug
IA Regimen:
Idarubicin: 8-12 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7.
Or DA Regimen:
Daunorubicin: 60 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7.
Or MA Regimen:
Mitoxantrone: 6-10 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7.
| Study group | Role | What they receive |
|---|---|---|
| Venetoclax Combined With CACAG Regimen | Experimental | The entire treatment period for the CACAG+Venetoclax regimen in the trial is 2 week, with a treatment cycle of every 4 weeks, and a total of 2 course of treatment.
Chidamide: 30 mg, twice a week, for a total of 4 administrations; Azacitidine: 75 mg/m^2 from day 1 to day 7; Cytarabine (Ara-C): 75-100 mg/m^2 every 12 hours from day 1 to day 7; Aclarubicin: 20 mg/m^2 on days 1, 3, and 5; Recombinant human granulocyte colony-stimulating factor (G-CSF): 300 μg/day, to be discontinued when neutrophils recover and white blood cell count is ≥20,000/μL; Venetoclax: 100 mg on day 1, 200 mg on day 2, 400 mg from day 3 to day 14, used in combination with azoles, with a reduced dosage of 100 mg/day. Receives: Drug: Azacytidine; Cytarabine; Aclacinomycin; Chidamide; Venetoclax; Granulocyte |
| the standard "3+7" regimen | Active comparator | IA Regimen:
Idarubicin: 8-12 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7.
Or DA Regimen:
Daunorubicin: 60 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7.
Or MA Regimen:
Mitoxantrone: 6-10 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7. Receives: Drug: the standard "3+7" regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Complete Remission (CRc) Rate after 1 course of treatment
a combination of complete remission (CR) and complete remission with incomplete blood count recovery (CRi)
Measured: 1 months after study treatment
Secondary outcomes (9)
Overall Response Rate (ORR) after 1 course of treatment
Defined as the percentage of participants achieving a best overall response of complete response (CR), CR with incomplete blood count recovery (CRi), or partial response (PR).Biological characteristics exploratory studies were analyzed by single-cell sequencing and Atac-seq. Further, according to European LeukemiaNet risk group, we analyzed the outcomes of patients by molecular subtype as a sub-group analysis.
Measured: 1 months after the start of study treatment
Complete Remission (CR) Rate after 1 courses of treatment
Defined in accordance with the IWG Response Criteria in AML. Bone marrow blasts<5 percent; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count >1.0 x 10^9/L (1000/µL); platelet count >100 x 109/L (100,000/µL); independence of red cell transfusions.
Measured: after 1 courses of chemotherapy (each course is 28 days)
Rate of Minimal Residual Disease (MRD)-Negative Response
Percentage of participants who achieved MRD-negative response, defined as < 1 leukemia cell per 10,000 leukocytes as assessed by flow cytometry after each courses of chemotherapy (each course is 28 days)
Measured: after each courses of chemotherapy (each course is 28 days)
Event-free survival
Defined as the time interval from treatment initiation to the occurrence of induction failure,relapse,or death,whichever came first.
Measured: 180 days after study treatment
Overall Survival
Defined as the time from joining the clinical study to death due to any cause.
Measured: 180 days after study treatment
Treatment-related adverse events
Defined as adverse events that occurred from the first dose of study treatment to 30 days after the discontinuation of treatment.
Measured: From the first dose of study treatment to 30 days after the discontinuation of treatment
Disease-free survival
Defined as the time interval from disease remission to the occurrence of relapse or death,whichever came first.
Measured: 180 days after study treatment Outcome Measure
Early death
Defined as death within 30 days of chemotherapy.
Measured: Within 30 days of the start of the first course of treatment
Complete Remission with Incomplete Blood Count Recovery (CRi)after 1 courses of treatment
Disappearance of leukemia blasts in the bone marrow (<5% blasts) but without full recovery of blood counts (neutrophils <1.0 x 10⁹/L and/or platelets <100 x 10⁹/L).
Measured: after 1 courses of chemotherapy (each course is 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start18 Nov 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- More trials run by Chinese PLA General 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, controlled clinical trial,
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- 940 Hospital of the People's Liberation Army Joint Logistic Support Force, The General Hospital of Western Theater Command, First Affiliated Hospital of Harbin Medical University, 960th Hospital of Joint Logistics Support Force of People's Liberation Army of China, Fourth Medical Center of PLA General Hospital, The First Medical Center of Chinese PLA General Hospital, The 306 Hospital of People's Liberation Army, Air Force General Hospital of the PLA
- Responsible party
- Principal investigator, Daihong Liu, Chinese PLA General Hospital
- Investigators
- Dahong Liu, Doctor, Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514936
- Sponsor's protocol ID
- KY-2024-9-140-2
- Status last verified
- Mar 2026
- First submitted
- 21 Nov 2025
- Last updated
- 20 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 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venetoclax-Azacitidine in Combination With Chidamide and CAG Versus 3+7 Regimen in Fit Older Patients With Acute Myeloid Leukaemia：A Multicenter, Randomized, Controlled, Phase 3 Trial
- ClinicalTrials.gov ID
- NCT07514936
- Acronym / sponsor ID
- KY-2024-9-140-2
- Keywords
- Elderly Patients, newly diagnosed, Acute Myeloid Leukemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- 940 Hospital of the People's Liberation Army Joint Logistic Support Force, The General Hospital of Western Theater Command, First Affiliated Hospital of Harbin Medical University, 960th Hospital of Joint Logistics Support Force of People's Liberation Army of China, Fourth Medical Center of PLA General Hospital, The First Medical Center of Chinese PLA General Hospital, The 306 Hospital of People's Liberation Army, Air Force General Hospital of the PLA
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Apr 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 study is a multicenter, prospective, randomized, controlled clinical trial, observing the efficacy and safety of the CACAG+Venetoclax regimen (Chidamide + Azacitidine + Aclarubicin + Cytarabine + Recombinant Human Granulocyte Colony-Stimulating Factor + Venetoclax) in elderly patients with newly diagnosed Acute Myeloid Leukemia (AML). The control group applies the standard "3+7" regimen. The aim is to improve the remission rate of AML patients, reduce the probability of adverse events, and thereby improve patient prognosis and extend patient survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized, controlled clinical trial,
| Arm | Type | Receives |
|---|---|---|
| Venetoclax Combined With CACAG Regimen | Experimental | Drug: Azacytidine; Cytarabine; Aclacinomycin; Chidamide; Venetoclax; GranulocyteThe entire treatment period for the CACAG+Venetoclax regimen in the trial is 2 week, with a treatment cycle of every 4 weeks, and a total of 2 course of treatment. Chidamide: 30 mg, twice a week, for a total of 4 administrations; Azacitidine: 75 mg/m^2 from day 1 to day 7; Cytarabine (Ara-C): 75-100 mg/m^2 every 12 hours from day 1 to day 7; Aclarubicin: 20 mg/m^2 on days 1, 3, and 5; Recombinant human granulocyte colony-stimulating factor (G-CSF): 300 μg/day, to be discontinued when neutrophils recover and white blood cell count is ≥20,000/μL; Venetoclax: 100 mg on day 1, 200 mg on day 2, 400 mg from day 3 to day 14, used in combination with azoles, with a reduced dosage of 100 mg/day. |
| the standard "3+7" regimen | Active comparator | Drug: the standard "3+7" regimenIA Regimen: Idarubicin: 8-12 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7. Or DA Regimen: Daunorubicin: 60 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7. Or MA Regimen: Mitoxantrone: 6-10 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntary participation in the clinical study; the subject or legal guardian fully understands and is informed about the study and has signed the Informed Consent Form (ICF); willing to follow and able to complete all trial procedures;
- Age between 60-75 years at the time of screening, with no gender restrictions;
- Patients are newly diagnosed with AML, and the diagnosis conforms to the standards of the Chinese Medical Association 2021 edition;
- No severe allergic constitution;
- Liver function: ALT and AST <= 2.5 times the upper limit of normal values, bilirubin <= 2 times the upper limit of normal values;
Key exclusion criteria (8 listed)
- Patients who are allergic to the study medication or have contraindications to it;
- Pregnant or breastfeeding women;
- Patients with active infections;
- Patients with long-term smoking or alcohol abuse that could affect the evaluation of trial results;
- Patients with mental disorders or other conditions that prevent obtaining informed consent, or who are unable to cooperate with the treatment and examination procedures;
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 |
|---|---|---|
| the standard "3+7" regimenIA Regimen: Idarubicin: 8-12 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7. Or DA Regimen: Daunorubicin: 60 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7. Or MA Regimen: Mitoxantrone: 6-10 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7. | Drug | the standard "3+7" regimen |
| Azacytidine; Cytarabine; Aclacinomycin; Chidamide; Venetoclax; GranulocyteIA Regimen: Idarubicin: 8-12 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7. Or DA Regimen: Daunorubicin: 60 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7. Or MA Regimen: Mitoxantrone: 6-10 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7. | Drug | Venetoclax Combined With CACAG Regimen |
Primary outcome
Composite Complete Remission (CRc) Rate after 1 course of treatment
Time frame: 1 months after study treatment
a combination of complete remission (CR) and complete remission with incomplete blood count recovery (CRi)
9 secondary outcomes
Overall Response Rate (ORR) after 1 course of treatment
Time frame: 1 months after the start of study treatment
Complete Remission (CR) Rate after 1 courses of treatment
Time frame: after 1 courses of chemotherapy (each course is 28 days)
Rate of Minimal Residual Disease (MRD)-Negative Response
Time frame: after each courses of chemotherapy (each course is 28 days)
Event-free survival
Time frame: 180 days after study treatment
Overall Survival
Time frame: 180 days after study treatment
Treatment-related adverse events
Time frame: From the first dose of study treatment to 30 days after the discontinuation of treatment
Disease-free survival
Time frame: 180 days after study treatment Outcome Measure
Early death
Time frame: Within 30 days of the start of the first course of treatment
Complete Remission with Incomplete Blood Count Recovery (CRi)after 1 courses of treatment
Time frame: after 1 courses of chemotherapy (each course is 28 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 20 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.
Dahong Liu, Doctor study chair
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing the standard "3+7" regimen and Azacytidine; Cytarabine; Aclacinomycin; Chidamide; Venetoclax; Granulocyte in people with Newly Diagnosed Acute Myeloid Leukemia (AML) and Elderly Patients, run by Chinese PLA General 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 8 inclusion and 8 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 20 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Dahong Liu Liu, doctor (+8613681171597, daihongrmg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Complete Remission (CRc) Rate after 1 course of treatment (time frame: 1 months after study treatment). 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 Aug 2026.