Acute Myeloid LeukemiaPhase 2NCT06220162
VAC Regimen for AML Patients Who Failed to Response to VA Regimen
A Phase 2 study testing chidamide in combination with venetoclax and azacitidine (VAC) in people with Acute Myeloid Leukemia, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
Chidamide in combination with venetoclax and azacitidine (VAC) were expected to improve remission rate of patients following to VA regimen treatment failure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- chidamide in combination with venetoclax and azacitidine (VAC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 1 Dec 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with AML who are not suitable for intensive chemotherapy according to the WHO diagnosis: age ≥60 years or age <60 years but fulfil the following criteria;
- Age 18 to 59 years;
- Eastern Cooperative Oncology Group (ECOG) physical status score of 2 or 3;
- Expected survival time ≥3 months;
- Or fulfilment of severe cardiac, pulmonary, hepatic, or renal disease; (A) Presence of a cardiac history of congestive heart failure, or ejection fraction ≤ 50%, or presence of chronic stable angina; (B) Lung carbon monoxide diffusing capacity (DLCO) ≤ 65%, or first forced expiratory volume (FEV1) ≤ 65%; (C) Moderate hepatic impairment with total bilirubin > 1.5 to ≤ 3.0 x upper limit of normal (ULN); (D) Creatinine clearance ≥ 30 mL/min to < 45 mL/min;
- Not received radiotherapy, treatment regimens other than the VA regimen, or haematopoietic stem cell transplantation within 4 weeks prior to enrolment;
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- Other comorbidities that, in the judgement of the physician, make the administration of intensive chemotherapy unsuitable;
- Ability to understand and willingness to sign the informed consent for this trial;
- The patient refuses intensive chemotherapy and has the willingness to accept non-intensive chemotherapy.
Who cannot join
- Patients with a history of myeloproliferative neoplasms (MPN), including myelofibrosis, thrombocythemia, polycythaemia vera, chronic granulocytic leukemia (CML) with or without BCR-ABL1 translocation, and AML or acute promyelocytic leukemia (APL) with BCR-ABL1 translocation;
- Patients with FLT3 mutations and who were treated with targeted agents (inclusion is possible if the use of specific targeted agents is discontinued);
- Patients with less than 50% reduction of blasts after VA regimen;
- Patients with active CNS involvement;
- With prior treatment with chidamide;
- Clinically uncontrolled active infections (including bacterial, fungal or viral infections) and organ hemorrhage;
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- Pregnant or lactating women;
- Participation in any other clinical trial within 3 months prior to VAC regimen;
- With other malignant tumours;
- With uncontrolled mental disorders;
- Any other condition that, in the opinion of the investigator, makes it inappropriate to participate in this trial.
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
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Sheng-Li N Xue, M.D., +8651267781139, slxue@suda.edu.cn
About this study
Official title: A Clinical Study of Chidamide in Combination With Venetoclax and Azacitidine (VAC) for Patients With Acute Myeloid Leukemia Who Did Not Achieve CR/CRi/MLFS (PR or NR) With One Cycle of Venetoclax and Azacitidine (VA).
Chidamide in combination with venetoclax and azacitidine (VAC) were expected to improve remission rate of patients following to VA regimen treatment failure.
Read the detailed description
Venetoclax and azacitidine has become the standard first-line treatment for elderly/unsuitable AML patients who can't tolerate for intense chemotherapy.
However, a proportion of patients who were not able to achieve remission after failing to VA regimen and then were given the second cycle, and their rate of achieving remission was even lower. Chidamide down-regulates the expression of MCL and is expected to improve the remission rate further in combination with VA regimen.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- chidamide in combination with venetoclax and azacitidine (VAC)
- Keywords
- AML venetoclax azacitidine chidamide unfit
- 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.
chidamide in combination with venetoclax and azacitidine (VAC)Drug
Enrolled patients were given chidamide 10 mg every day on days 1-14, azacitidine 75mg/m2 every day on days 1-7, and oral venetoclax began at 100mg on day 1 and increased stepwise over 3 days to reach the target dose of 400mg (100mg, 200mg, and 400mg) on days 1-28. Dose adjustments for concomitant venetoclax with CYP3A4 inhibitors were made according to the literature.
| Study group | Role | What they receive |
|---|---|---|
| VAC regimen | Experimental | Not described Receives: Drug: chidamide in combination with venetoclax and azacitidine (VAC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR(overall response rate)
ORR was calculated as the sum of CR, CRi, MLFS and PR.
Measured: 1 month
Secondary outcomes (3)
OS (Overall survival)
OS was defined as the time from enrollment to this study to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.
Measured: 2 years
EFS (Event-free survival)
EFS was defined as the time from the initiation of CAV to treatment failure, relapse, death from any cause or the last follow-up.
Measured: 2 years
Adverse events (AEs)
It is evaluated and graded according to CTCAE 5.0.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start1 Feb 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (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 The First Affiliated Hospital of Soochow UniversityThe 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
- 32 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jining Medical University, The Second People's Hospital of Huai'an, The First Affiliated Hospital of Bengbu Medical University, Northern Jiangsu People's Hospital, Affiliated Hospital of Nantong University
- Responsible party
- Principal investigator, Sheng-Li Xue, MD, The First Affiliated Hospital of Soochow University
- Investigators
- Sheng-Li Xue, Study chair, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220162
- Sponsor's protocol ID
- SZAML04
- Status last verified
- Mar 2026
- First submitted
- 6 Jan 2024
- Last updated
- 19 Mar 2026
- Results posted
- 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 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Chidamide in Combination With Venetoclax and Azacitidine (VAC) for Patients With Acute Myeloid Leukemia Who Did Not Achieve CR/CRi/MLFS (PR or NR) With One Cycle of Venetoclax and Azacitidine (VA).
- ClinicalTrials.gov ID
- NCT06220162
- Acronym / sponsor ID
- SZAML04
- Conditions
- Acute Myeloid Leukemia
- Keywords
- AML venetoclax azacitidine chidamide unfit
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- Jining Medical University, The Second People's Hospital of Huai'an, The First Affiliated Hospital of Bengbu Medical University, Northern Jiangsu People's Hospital, Affiliated Hospital of Nantong University
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 23 Jan 2024 (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.
Chidamide in combination with venetoclax and azacitidine (VAC) were expected to improve remission rate of patients following to VA regimen treatment failure.
Detailed description
Venetoclax and azacitidine has become the standard first-line treatment for elderly/unsuitable AML patients who can't tolerate for intense chemotherapy.
However, a proportion of patients who were not able to achieve remission after failing to VA regimen and then were given the second cycle, and their rate of achieving remission was even lower. Chidamide down-regulates the expression of MCL and is expected to improve the remission rate further in combination with VA regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VAC regimen | Experimental | Drug: chidamide in combination with venetoclax and azacitidine (VAC) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with AML who are not suitable for intensive chemotherapy according to the WHO diagnosis: age ≥60 years or age <60 years but fulfil the following criteria;
- Age 18 to 59 years;
- Eastern Cooperative Oncology Group (ECOG) physical status score of 2 or 3;
- Expected survival time ≥3 months;
- Or fulfilment of severe cardiac, pulmonary, hepatic, or renal disease; (A) Presence of a cardiac history of congestive heart failure, or ejection fraction ≤ 50%, or presence of chronic stable angina; (B) Lung carbon monoxide diffusing capacity (DLCO) ≤ 65%, or first forced expiratory volume (FEV1) ≤ 65%; (C) Moderate hepatic impairment with total bilirubin > 1.5 to ≤ 3.0 x upper limit of normal (ULN); (D) Creatinine clearance ≥ 30 mL/min to < 45 mL/min;
Key exclusion criteria (11 listed)
- Patients with a history of myeloproliferative neoplasms (MPN), including myelofibrosis, thrombocythemia, polycythaemia vera, chronic granulocytic leukemia (CML) with or without BCR-ABL1 translocation, and AML or acute promyelocytic leukemia (APL) with BCR-ABL1 translocation;
- Patients with FLT3 mutations and who were treated with targeted agents (inclusion is possible if the use of specific targeted agents is discontinued);
- Patients with less than 50% reduction of blasts after VA regimen;
- Patients with active CNS involvement;
- With prior treatment with chidamide;
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 |
|---|---|---|
| chidamide in combination with venetoclax and azacitidine (VAC)Enrolled patients were given chidamide 10 mg every day on days 1-14, azacitidine 75mg/m2 every day on days 1-7, and oral venetoclax began at 100mg on day 1 and increased stepwise over 3 days to reach the target dose of 400mg (100mg, 200mg, and 400mg) on days 1-28. Dose adjustments for concomitant venetoclax with CYP3A4 inhibitors were made according to the literature. | Drug | VAC regimen |
Primary outcome
ORR(overall response rate)
Time frame: 1 month
ORR was calculated as the sum of CR, CRi, MLFS and PR.
3 secondary outcomes
OS (Overall survival)
Time frame: 2 years
EFS (Event-free survival)
Time frame: 2 years
Adverse events (AEs)
Time frame: 2 months
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 19 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.
Sheng-Li Xue study chair
The First Affiliated Hospital of Soochow University
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 chidamide in combination with venetoclax and azacitidine (VAC) in people with Acute Myeloid Leukemia, run by The First Affiliated Hospital of Soochow University 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 9 inclusion and 11 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 19 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 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?
Contact Sheng-Li Xue, M.D. (+8651267781139, slxue@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR(overall response rate) (time frame: 1 month). 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 19 Mar 2026.