Leukemia, Myeloid, AcutePhase 2NCT05305859
Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of R/R AML
A Phase 2 study testing venetoclax combining chidamide and azacitidine (VCA) in people with Leukemia, Myeloid, Acute and Relapsed Adult AML, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of relapsed and/or refractory AML Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myeloid, Acute, Relapsed Adult AML, Refractory Leukemia
- What is being tested?
- venetoclax combining chidamide and azacitidine (VCA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 12 Jan 2022to 30 Jun 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18
- Relapsed and refractory patients with acute myeloid leukemia via morphology and immunology
- ECOG：0-2
- Life expectancy ≥ 3 months
- Adequate laboratory parameters during the screening period as evidenced by the following:
- Creatinine clearance≥30 mL/min and serum Creatinine ≤ 160µmol/L
- ALT and AST ≤ 3 × upper limit of normal (ULN)
- Able to understand and sign an informed consent form (ICF).
Who cannot join
- Diagnosis of acute promyelocytic leukemia (APL)
- Central nervous system leukemia
- Uncontrolled or significant cardiovascular disease, including any of the following:
- Bradycardia of less than 50 beats per minute, unless the subject has a pacemaker; Diagnosis of or suspicion of long QT syndrome (including family history of long QT syndrome);
- Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg; History of clinically relevant ventricular arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes);
- History of second (Mobitz II) or third degree heart block (subjects with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker);
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- History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to Screening;
- History of New York Heart Association Class 3 or 4 heart failure;
- Complete left bundle branch block;
- Known history of left ventricular ejection fraction (LVEF) ≤45% or less than the institutional lower limit of normal;
- Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy;
- Suffered from other non-myeloid malignancies within 2 years, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease
- Females who are pregnant or breastfeeding;
- Mental disorders that hinder research participation
- Previous solid organ transplantation (SCT treatment is allowed in advance, but if the patient has GVHD or is still receiving immunosuppression/GVHD treatment, it is not allowed)
- Any other situation where the investigator believes that the patient should not 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
Bing Xu
Xiamen, Fujian, 361003
Bing Xu
Bing Xu
About this study
Official title: A Multi-center, Prospective, Single-arm Study of Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of Refractory/Relapsed Acute Myelogenous Leukemia (R/R AML)
The purpose of this study is to evaluate the safety and efficacy of Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of relapsed and/or refractory AML
Read the detailed description
Patients with relapsed and/or refractory AML have inferior outcomes. The regimen of Venetoclax and Azacitidine has been widely used in the treatment of RR AML and has proved to achieve CR rate of 30% ~ 40%. However, the median duration of response (DOR) of this regimen is about one year. Chidamide is a histone deacetylase (HDAC) inhibitor and preclinical data showed adding low-dose Chidamide to venetoclax could significantly promoted apoptosis of leukemia cell lines. Meanwhile, the Venetoclax Combining Chidamide and Azacitidine (VCA) regimen was applied to 2 patients with refractory AML. This regimen was well tolerated and both patients achieved CR after one cycle. Thus, we register this clinical trial and evaluate the safety and efficacy of VCA regimen.
- Being tested
- venetoclax combining chidamide and azacitidine (VCA)
- Keywords
- refractory/relapsed acute myelogenous leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venetoclax combining chidamide and azacitidine (VCA)Drug
Also called VCA
information already included in arm/group descriptions
| Study group | Role | What they receive |
|---|---|---|
| venetoclax combining chidamide and azacitidine (VCA) | Experimental | 28 days per cycle × at least 2 cycles；
1) chidamide 30mg biw × 2weeks；2) venetoclax 200mg/d × 2 weeks 3) azacitidine 100mg/d d1-7 Receives: Drug: venetoclax combining chidamide and azacitidine (VCA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission (CR) rate
CR was <5% marrow blasts by morphology
Measured: 2 months
Overall response rate (ORR)
ORR is defined as CR, CRi and PR.
Measured: 2 months
Secondary outcomes (3)
1 year leukemia free survival (LFS)
Leukemia-free survival (LFS) is defined as survival without evidence of relapse from treatment initiation
Measured: 1 year from treatment initiation
1year overall survival (OS)
Overall survival（OS）is defined as the time from treatment initiation to death from any cause.
Measured: 1 year from treatment initiation
Adverse events
Adverse event is defined as any untoward medical occurrence associated with treatment
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 posted31 Mar 2022
- Study start12 Jan 2022
- Primary completion31 Jan 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myeloid, AcuteStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen 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
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fujian Provincial Hospital, Fujian Cancer Hospital, Zhangzhou Municipal Hospital of Fujian Province, Jieyang People's Hospital, Dongguan People's Hospital, Huizhou Municipal Central Hospital
- Responsible party
- Sponsor
- Investigators
- Bing Xu, Principal investigator, The First Affiliated Hospital of Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305859
- Sponsor's protocol ID
- FXMH-AML-001
- Other IDs
- ChiCTR2200056657
- Status last verified
- Sep 2025
- First submitted
- 8 Mar 2022
- Last updated
- 11 Sep 2025
- 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 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Prospective, Single-arm Study of Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of Refractory/Relapsed Acute Myelogenous Leukemia (R/R AML)
- ClinicalTrials.gov ID
- NCT05305859
- Acronym / sponsor ID
- FXMH-AML-001
- Keywords
- refractory/relapsed acute myelogenous leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Collaborators
- Fujian Provincial Hospital, Fujian Cancer Hospital, Zhangzhou Municipal Hospital of Fujian Province, Jieyang People's Hospital, Dongguan People's Hospital, Huizhou Municipal Central Hospital
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 31 Mar 2022 (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.
The purpose of this study is to evaluate the safety and efficacy of Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of relapsed and/or refractory AML
Detailed description
Patients with relapsed and/or refractory AML have inferior outcomes. The regimen of Venetoclax and Azacitidine has been widely used in the treatment of RR AML and has proved to achieve CR rate of 30% ~ 40%. However, the median duration of response (DOR) of this regimen is about one year. Chidamide is a histone deacetylase (HDAC) inhibitor and preclinical data showed adding low-dose Chidamide to venetoclax could significantly promoted apoptosis of leukemia cell lines. Meanwhile, the Venetoclax Combining Chidamide and Azacitidine (VCA) regimen was applied to 2 patients with refractory AML. This regimen was well tolerated and both patients achieved CR after one cycle. Thus, we register this clinical trial and evaluate the safety and efficacy of VCA regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| venetoclax combining chidamide and azacitidine (VCA) | Experimental | Drug: venetoclax combining chidamide and azacitidine (VCA)28 days per cycle × at least 2 cycles； 1) chidamide 30mg biw × 2weeks；2) venetoclax 200mg/d × 2 weeks 3) azacitidine 100mg/d d1-7 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18
- Relapsed and refractory patients with acute myeloid leukemia via morphology and immunology
- ECOG：0-2
- Life expectancy ≥ 3 months
- Adequate laboratory parameters during the screening period as evidenced by the following:
Key exclusion criteria (16 listed)
- Diagnosis of acute promyelocytic leukemia (APL)
- Central nervous system leukemia
- Uncontrolled or significant cardiovascular disease, including any of the following:
- Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy;
- Suffered from other non-myeloid malignancies within 2 years, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease
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 |
|---|---|---|
| venetoclax combining chidamide and azacitidine (VCA)Also: VCAinformation already included in arm/group descriptions | Drug | venetoclax combining chidamide and azacitidine (VCA) |
Primary outcome
Complete remission (CR) rate
Time frame: 2 months
CR was <5% marrow blasts by morphology
Overall response rate (ORR)
Time frame: 2 months
ORR is defined as CR, CRi and PR.
3 secondary outcomes
1 year leukemia free survival (LFS)
Time frame: 1 year from treatment initiation
1year overall survival (OS)
Time frame: 1 year from treatment initiation
Adverse events
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 11 Sep 2025.
- 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.
Bing Xu principal investigator
The First Affiliated Hospital of Xiamen 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 venetoclax combining chidamide and azacitidine (VCA) in people with Leukemia, Myeloid, Acute and Relapsed Adult AML, run by The First Affiliated Hospital of Xiamen 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 8 inclusion and 16 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 11 Sep 2025. 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 Bing Xu, M.D. (+865922137255, xubingzhangjian@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission (CR) rate (time frame: 2 months). The study lists 2 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 11 Sep 2025.