Relapsed or Refractory Acute Myeloid LeukemiaPhase 2NCT07783100
Venetoclax, Chidamide, and Chiglitazar Sodium (VCC) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
A Phase 2 study testing venetoclax, chidamide, and chiglitazar sodium (VCC) in people with Relapsed or Refractory Acute Myeloid Leukemia, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
To evaluate the efficacy and safety of venetoclax, chidamide, and chiglitazar sodium (VCC) in patients with relapsed or refractory acute myeloid leukemia (R/R AML). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Acute Myeloid Leukemia
- What is being tested?
- venetoclax, chidamide, and chiglitazar sodium (VCC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2026to 30 Nov 2028
- 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
- Histologically confirmed acute myeloid leukemia (AML) with relapsed or refractory disease, including:
- Refractory AML, defined as failure to achieve remission after at least one prior treatment;
- Relapsed AML, defined as ≥5% blasts in the bone marrow after a previous remission;
- AML arising from myelodysplastic syndrome (including CMML) or myeloproliferative neoplasms (secondary AML or therapy-related AML [t-AML]) is also eligible.
- Age ≥18 years, regardless of sex, with an expected survival of >3 months.
- Estimated creatinine clearance ≥50 mL/min.
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- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 × the upper limit of normal (ULN), unless the abnormality is considered attributable to leukemic organ involvement; total bilirubin ≤3.0 × ULN, unless the abnormality is considered attributable to leukemic organ involvement.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Participants must not be pregnant and must agree to use effective contraception during study treatment.
- Ability to understand the study and willingness to provide written informed consent.
Who cannot join
- Acute promyelocytic leukemia (APL).
- Active central nervous system leukemia.
- Clinically significant cardiovascular disease, including any of the following:
- Clinically significant QTc prolongation (QTc >450 ms in males or >470 ms in females);
- Ventricular tachycardia;
- Second-degree atrioventricular block;
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- Myocardial infarction within 1 year prior to enrollment;
- Congestive heart failure;
- Coronary artery disease requiring medical treatment.
- Active, uncontrolled severe infection.
- Other non-hematologic malignancies within the previous 2 years.
- Psychiatric disorders that may interfere with participation in the study.
- Previous solid organ transplantation. Prior stem cell transplantation (SCT) is permitted; however, patients with graft-versus-host disease (GVHD) or those receiving ongoing immunosuppressive or GVHD-directed therapy are not eligible.
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study.
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 xiamen university
Xiamen, Fujian
Bing Xu, 18750918842 ext. 86, xubingzhangjian@126.com
About this study
Official title: A Multicenter, Prospective, Single-Arm Study of Venetoclax, Chidamide, and Chiglitazar Sodium (VCC) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
To evaluate the efficacy and safety of venetoclax, chidamide, and chiglitazar sodium (VCC) in patients with relapsed or refractory acute myeloid leukemia (R/R AML).
Read the detailed description
This is a multicenter, prospective, single-arm clinical study evaluating the efficacy and safety of venetoclax, chidamide, and chiglitazar sodium (VCC) in patients with relapsed or refractory acute myeloid leukemia (R/R AML). Participants will receive VCC combination therapy according to the study protocol. The primary objective is to evaluate the antileukemic efficacy of the VCC regimen, while safety and tolerability will also be assessed throughout the study.
- Being tested
- venetoclax, chidamide, and chiglitazar sodium (VCC)
- Keywords
- venetoclax, chidamide, chiglitazar sodium
- Medical subject headings
- Recurrence, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venetoclax, chidamide, and chiglitazar sodium (VCC)Drug
Participants will receive oral chidamide 30 mg twice weekly for 2 weeks, venetoclax 200 mg once daily for 2 weeks, and chiglitazar sodium 48 mg once daily on Days 1-28 of each 28-day cycle. At least two cycles will be administered. Dose modifications are permitted according to clinical condition, laboratory findings, adverse events, and venetoclax plasma concentrations.
| Study group | Role | What they receive |
|---|---|---|
| VCC | Experimental | Chidamide, venetoclax, chiglitazar sodium. Receives: Drug: venetoclax, chidamide, and chiglitazar sodium (VCC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Complete Remission Rate (CR + CRi)
The proportion of participants who achieve complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) following VCC treatment. Treatment response will be assessed according to the response criteria specified in the study protocol.
Measured: Up to 12 months
Secondary outcomes (4)
1-Year Progression-Free Survival (PFS)
The proportion of participants who are alive without disease progression at 1 year after initiation of VCC treatment. Progression-free survival is defined as the time from initiation of study treatment to disease progression or death from any cause, whichever occurs first.
Measured: Up to 12 months
1-Year Overall Survival (OS)
The proportion of participants who are alive at 1 year after initiation of VCC treatment. Overall survival is defined as the time from initiation of study treatment to death from any cause.
Measured: Up to 12 months
Change in Health-Related Quality of Life Assessed by EQ-5D-5L
Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. Changes in patient-reported health status during treatment will be evaluated relative to baseline.
Measured: Up to 24 months
Incidence of Adverse Events
The incidence and severity of adverse events occurring during study treatment will be assessed based on clinical symptoms, physical examinations, vital signs, laboratory findings, and other clinically relevant safety parameters. Adverse events will be graded according to the toxicity grading criteria specified in the study protocol.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start11 Nov 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Acute Myeloid LeukemiaStudies 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
- Model description
- Participants will receive oral chidamide 30 mg twice weekly for 2 weeks, venetoclax 200 mg once daily for 2 weeks, and chiglitazar sodium 48 mg once daily on Days 1-28 of each 28-day cycle. At least two cycles will be administered. Dose modifications are permitted according to clinical condition, laboratory findings, adverse events, and venetoclax plasma concentrations.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bing, Xu, The First Affiliated Hospital of Xiamen University
- Investigators
- Bing Xu, Principal investigator, The First Affiliated Hospital of Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783100
- Sponsor's protocol ID
- 20260820VCC
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Single-Arm Study of Venetoclax, Chidamide, and Chiglitazar Sodium (VCC) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT07783100
- Acronym / sponsor ID
- 20260820VCC
- Keywords
- venetoclax, chidamide, chiglitazar sodium
- 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
- Study start
- 11 Nov 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 24 Aug 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.
To evaluate the efficacy and safety of venetoclax, chidamide, and chiglitazar sodium (VCC) in patients with relapsed or refractory acute myeloid leukemia (R/R AML).
Detailed description
This is a multicenter, prospective, single-arm clinical study evaluating the efficacy and safety of venetoclax, chidamide, and chiglitazar sodium (VCC) in patients with relapsed or refractory acute myeloid leukemia (R/R AML). Participants will receive VCC combination therapy according to the study protocol. The primary objective is to evaluate the antileukemic efficacy of the VCC regimen, while safety and tolerability will also be assessed throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will receive oral chidamide 30 mg twice weekly for 2 weeks, venetoclax 200 mg once daily for 2 weeks, and chiglitazar sodium 48 mg once daily on Days 1-28 of each 28-day cycle. At least two cycles will be administered. Dose modifications are permitted according to clinical condition, laboratory findings, adverse events, and venetoclax plasma concentrations.
| Arm | Type | Receives |
|---|---|---|
| VCC | Experimental | Drug: venetoclax, chidamide, and chiglitazar sodium (VCC)Chidamide, venetoclax, chiglitazar sodium. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed acute myeloid leukemia (AML) with relapsed or refractory disease, including:
- Age ≥18 years, regardless of sex, with an expected survival of >3 months.
- Estimated creatinine clearance ≥50 mL/min.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 × the upper limit of normal (ULN), unless the abnormality is considered attributable to leukemic organ involvement; total bilirubin ≤3.0 × ULN, unless the abnormality is considered attributable to leukemic organ involvement.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
Key exclusion criteria (14 listed)
- Acute promyelocytic leukemia (APL).
- Active central nervous system leukemia.
- Clinically significant cardiovascular disease, including any of the following:
- Active, uncontrolled severe infection.
- Other non-hematologic malignancies within the previous 2 years.
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, chidamide, and chiglitazar sodium (VCC)Participants will receive oral chidamide 30 mg twice weekly for 2 weeks, venetoclax 200 mg once daily for 2 weeks, and chiglitazar sodium 48 mg once daily on Days 1-28 of each 28-day cycle. At least two cycles will be administered. Dose modifications are permitted according to clinical condition, laboratory findings, adverse events, and venetoclax plasma concentrations. | Drug | VCC |
Primary outcome
Composite Complete Remission Rate (CR + CRi)
Time frame: Up to 12 months
The proportion of participants who achieve complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) following VCC treatment. Treatment response will be assessed according to the response criteria specified in the study protocol.
4 secondary outcomes
1-Year Progression-Free Survival (PFS)
Time frame: Up to 12 months
1-Year Overall Survival (OS)
Time frame: Up to 12 months
Change in Health-Related Quality of Life Assessed by EQ-5D-5L
Time frame: Up to 24 months
Incidence of Adverse Events
Time frame: Up to 12 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 24 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.
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, chidamide, and chiglitazar sodium (VCC) in people with Relapsed or Refractory Acute Myeloid Leukemia, 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 10 inclusion and 14 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 24 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 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, PhD (18750918842 ext. 86, xubingzhangjian@126.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: Up to 12 months). 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 24 Aug 2026.