AML (Acute Myeloid Leukemia)Phase 2NCT07643636
Chidamide, Venetoclax, Azacitidine, and Homoharringtonine for High-risk Fit AML
A Phase 2 study testing Chidamide (Chi)+VAH in people with AML (Acute Myeloid Leukemia), run by Dongguan People's Hospital.
Trial summary
This study aims to explore a superior first-line induction remission regimen by incorporating Chidamide into the modified VAH chemotherapy combined with targeted therapy regimen, leveraging its dual epigenetic modulation mechanism. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- AML (Acute Myeloid Leukemia)
- What is being tested?
- Chidamide (Chi)+VAH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2026to 1 Jun 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Newly diagnosed fit-AML patients classified per the World Health Organization (WHO) classification criteria.
- Age ranging from 18 to 60 years, no restriction on gender.
- No prior anti-AML systemic therapy after AML diagnosis; cytoreductive treatment (e.g., hydroxyurea or cytarabine at a daily dose <1.0 g) is permitted as exception.
- Estimated overall survival ≥12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤3 points.
- Renal function: calculated creatinine clearance (CrCl) ≥30 mL/min.
- Hepatic function: alanine aminotransferase (ALT) <5× upper limit of normal (ULN); total bilirubin <3× ULN.
- Able to provide written informed consent and understand as well as comply with all study-specified procedures.
Who cannot join
- Patients stratified as favorable-risk AML defined by NCCN Guidelines 2022, including cytogenetic aberrations: t(8;21)(q22;q22.1); RUNX1-RUNX1T1, inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11.
- Confirmed acute promyelocytic leukemia (APL). AML complicated with central nervous system (CNS) leukemia infiltration.
- Cardiac function exceeding NYHA functional class II.
- Confirmed human immunodeficiency virus (HIV) infection or other uncontrolled clinically significant comorbidities, including but not limited to:
- Uncontrolled or active systemic infection (viral, bacterial or fungal); ② Concurrent second primary malignancy requiring urgent clinical intervention.
- 6. Patients unable to receive oral chidamide and/or venetoclax administration. 7. Known hypersensitivity to any investigational product. 8. Pregnant or breastfeeding female subjects. 9. Inability to understand or adhere to the study protocol requirements. 10.Subjects deemed unsuitable for enrollment at the investigator's discretion
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: A Single-arm, Single-center Clinical Trial Evaluating the Efficacy and Safety of a Regimen Combining Chidamide With Venetoclax, Azacitidine, and Homoharringtonine in the Treatment of Intermediate- to High-risk Fit AML Patients
This study aims to explore a superior first-line induction remission regimen by incorporating Chidamide into the modified VAH chemotherapy combined with targeted therapy regimen, leveraging its dual epigenetic modulation mechanism.
- Conditions
- AML (Acute Myeloid Leukemia)
- Being tested
- Chidamide (Chi)+VAH
- 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 (Chi)+VAHDrug
Induction (Chi+VAH Regimen):
Cycle 1: Chi+VAH regimen (28-day cycle).
Assessment \& Cycle 2:
CR/CRi: Repeat one cycle → Proceed to post-remission therapy. PR: Repeat one cycle → Re-assess. If CR/CRi → Proceed to post-remission therapy.
NR: Discontinue study.
Post-Remission / Consolidation:
1-2 cycles of either intermediate-dose Cytarabine (± targeted therapy) OR the Chi+VAH regimen.
Eligible patients should proceed to allogeneic HSCT.
Maintenance (Non-transplant):
MRD-negative: VA (Venetoclax + Azacitidine) until relapse, intolerance, or 1 year.
MRD-positive: Chi+VAH or clinical trial until MRD negativity, then switch to VA maintenance.
| Study group | Role | What they receive |
|---|---|---|
| Chidamide , Venetoclax, Azacitidine, Homoharringtonine | Experimental | Not described Receives: Drug: Chidamide (Chi)+VAH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Complete Remission Rate （CR+CRi）
Measured: the First Induction Cycle （28days）
Secondary outcomes (6)
MRD negativity rate after the first induction cycle
Measured: 28 days
Composite CR/CRi rate after the second induction cycle
Measured: 56 days
2-year overall survival (OS) rate
Measured: 2 years
2-year relapse-free survival (RFS) rate
Measured: 2 years
Bridging Rate to Allo-HSCT
Measured: 2 years
Non-relapse mortality (NRM)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start30 Jun 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML (Acute Myeloid Leukemia)Studies of the same condition, open and under way.
- 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
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongguan People's Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643636
- Sponsor's protocol ID
- CSIIT-A58
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 18 Jun 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 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Single-center Clinical Trial Evaluating the Efficacy and Safety of a Regimen Combining Chidamide With Venetoclax, Azacitidine, and Homoharringtonine in the Treatment of Intermediate- to High-risk Fit AML Patients
- ClinicalTrials.gov ID
- NCT07643636
- Acronym / sponsor ID
- CSIIT-A58
- Conditions
- AML (Acute Myeloid Leukemia)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Dongguan People's HospitalOther government
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 11 Jun 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 aims to explore a superior first-line induction remission regimen by incorporating Chidamide into the modified VAH chemotherapy combined with targeted therapy regimen, leveraging its dual epigenetic modulation mechanism.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chidamide , Venetoclax, Azacitidine, Homoharringtonine | Experimental | Drug: Chidamide (Chi)+VAH |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Newly diagnosed fit-AML patients classified per the World Health Organization (WHO) classification criteria.
- Age ranging from 18 to 60 years, no restriction on gender.
- No prior anti-AML systemic therapy after AML diagnosis; cytoreductive treatment (e.g., hydroxyurea or cytarabine at a daily dose <1.0 g) is permitted as exception.
- Estimated overall survival ≥12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤3 points.
Key exclusion criteria (6 listed)
- Patients stratified as favorable-risk AML defined by NCCN Guidelines 2022, including cytogenetic aberrations: t(8;21)(q22;q22.1); RUNX1-RUNX1T1, inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11.
- Confirmed acute promyelocytic leukemia (APL). AML complicated with central nervous system (CNS) leukemia infiltration.
- Cardiac function exceeding NYHA functional class II.
- Confirmed human immunodeficiency virus (HIV) infection or other uncontrolled clinically significant comorbidities, including but not limited to:
- 6. Patients unable to receive oral chidamide and/or venetoclax administration. 7. Known hypersensitivity to any investigational product. 8. Pregnant or breastfeeding female subjects. 9. Inability to understand or adhere to the study protocol requirements. 10.Subjects deemed unsuitable for enrollment at the investigator's discretion
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 (Chi)+VAHInduction (Chi+VAH Regimen): Cycle 1: Chi+VAH regimen (28-day cycle). Assessment \& Cycle 2: CR/CRi: Repeat one cycle → Proceed to post-remission therapy. PR: Repeat one cycle → Re-assess. If CR/CRi → Proceed to post-remission therapy. NR: Discontinue study. Post-Remission / Consolidation: 1-2 cycles of either intermediate-dose Cytarabine (± targeted therapy) OR the Chi+VAH regimen. Eligible patients should proceed to allogeneic HSCT. Maintenance (Non-transplant): MRD-negative: VA (Venetoclax + Azacitidine) until relapse, intolerance, or 1 year. MRD-positive: Chi+VAH or clinical trial until MRD negativity, then switch to VA maintenance. | Drug | Chidamide , Venetoclax, Azacitidine, Homoharringtonine |
Primary outcome
Composite Complete Remission Rate （CR+CRi）
Time frame: the First Induction Cycle （28days）
6 secondary outcomes
MRD negativity rate after the first induction cycle
Time frame: 28 days
Composite CR/CRi rate after the second induction cycle
Time frame: 56 days
2-year overall survival (OS) rate
Time frame: 2 years
2-year relapse-free survival (RFS) rate
Time frame: 2 years
Bridging Rate to Allo-HSCT
Time frame: 2 years
Non-relapse mortality (NRM)
Time frame: 2 years
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 18 Jun 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chidamide (Chi)+VAH in people with AML (Acute Myeloid Leukemia), run by Dongguan People's Hospital.
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 6 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 18 Jun 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 Zhangkun Li (0769-28637333, lzk8239@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 Rate （CR+CRi） (time frame: the First Induction Cycle （28days）). 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 18 Jun 2026.