Acute Myeloid LeukemiaNCT07822789
Chidamide in HR-AML
An observational study of Acute Myeloid Leukemia and Maintenance Therapy, run by Guangdong Second Provincial General Hospital at 1 site in China.
Trial summary
Acute myeloid leukemia (AML) patients with fusion gene-positive including core binding factor (CBF), mixed-lineage leukemia (MLL) gene rearrangement have a high incidence of relapse if they have continuously positive measurable residual disease (MRD) or ELN 2022-high risk chromosome abnormality and could not be… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Myeloid Leukemia, Maintenance Therapy
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 27 Jul 2026to 31 Jul 2027
- Phase
- Observational
- 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
Study population: High-risk patients who had completed standard induction and consolidation therapy and achieved complete remission (CR) or CR with incomplete peripheral blood count recovery (CRi), and could not receive allo-HSCT, and had taken chidamide as maintenance therapy for at least 3 months. High-risk patients were defined as those with CFB-AML and MRD positive, or patients with ELN 2022-high risk fusion genes, such as MLL rearrangement, or NUP98 rearrangement, ect.
Who may be able to join
- Age range ≥18 years, both male and female were eligible.
- Patients with CFB-AML and MRD positive, or patients with ELN 2022-high risk fusion genes, such as MLL rearrangement, or NUP98 rearrangement, ect.
- Use of chidamide-based regimens as maintenance therapy for at least 3 months, without undergoing or not planning to undergo allo-HSCT.
- ECOG ≤4;
- At screening, laboratory tests meet the following criteria: (1) Complete blood count: hemoglobin (Hb) ≥90 g/L, absolute neutrophil count (ANC) ≥1.5×10⁹/L, platelet count (PLT) ≥90×10⁹/L; (2) Biochemical tests: serum creatinine (Cr) ≤1.5× upper limit of normal (ULN); total bilirubin (TBIL) ≤1.5×ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (for cases with liver metastasis: ≤5×ULN).
Who cannot join
- Known history of allergy to the study drug.
- Resistant to chidamide.
- Unable to take oral medications.
- Concurrent uncontrolled active infection (including bacterial, fungal, or viral infections).
- Concurrent uncontrolled major organ failure.
- Currently participating in other clinical studies that affected the primary objectives of this study.
- Patients deemed by the investigators to be unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Hematology, Guangdong Second Provincial General Hospital
Guangzhou, Guangdong
About this study
Official title: Efficacy and Safety of Chidamide in the Maintenance Therapy of High-Risk Acute Myeloid Leukemia Patients: A Multi-center Real-World Study
Acute myeloid leukemia (AML) patients with fusion gene-positive including core binding factor (CBF), mixed-lineage leukemia (MLL) gene rearrangement have a high incidence of relapse if they have continuously positive measurable residual disease (MRD) or ELN 2022-high risk chromosome abnormality and could not be bridged to allogenetic heamatopoitic stem cell transplantation (allo-HSCT). Histone deacetylase (HDAC) is known to abnormally recruit in these fusion gene-positive AML, and has been proven to be a promising therapy target. Whether HDAC inhibitor chidamide could be used as a maintenance therapy in these AML patients remains unknown. This study aims to evaluate the efficacy and safety of chidamide in the maintenance therapy of high-risk acute myeloid leukemia (AML) patients with core binding factor (CBF) and measurable residual disease (MRD) positivity, or ELN 2022-high risk fusion gene positive.
Read the detailed description
Despite the above data providing positive signals for the application of chidamide in fusion gene AML, particularly in high-risk patients, there remain significant gaps in the evidence: 1) most supportive data come from combination therapy in relapsed/refractory settings or post-transplant interventions, and systematic studies on its use as a post-remission maintenance therapy after initial induction are still lacking; 2) existing studies related to maintenance therapy are mostly small-sample retrospective analyses, lacking supportive data from prospective, or multi-center, or large scale designs; 3) for the definition of 'high-risk,' especially incorporating 'MRD-positive' as a strong prognostic indicator in patient selection criteria and evaluating the value of maintenance therapy accordingly, research is still insufficient.
Based on the clinical dilemma of high relapse risk after remission in high-risk fusion gene AML patients, and the scientific rationale of chidamide exerting anti-leukemia effects through multiple mechanisms such as correcting epigenetic abnormalities, inducing differentiation, and modulating immunity, combined with its efficacy and safety signals in R/R and post-transplant settings, we propose conducting clinical research on chidamide as maintenance therapy in high-risk fusion gene-positive AML. This study aims to focus on the high-risk patient group who have completed standard induction and consolidation therapy, achieved morphological remission but remain MRD-positive (including CBF-AML and MLL-r AML), who are at extremely high risk of relapse under current standard treatment, and may be unable or not planning to undergo allo-HSCT due to age, comorbidities, or lack of suitable donors. Evaluating whether chidamide as maintenance therapy can effectively clear MRD, reduce relapse rates, prolong disease-free survival and overall survival, and clarify its safety profile in this specific population has significant clinical and scientific value, and is expected to provide a new and effective maintenance therapy option for this high-risk AML population, improving their long-term prognosis.
Therefore, conducting this study is an important exploration responding to urgent clinical needs, continuing the chain of evidence from basic and preclinical studies, and striving to fill the gap in the field of maintenance therapy for high-risk AML.
- Conditions
- Acute Myeloid Leukemia, Maintenance Therapy
- Keywords
- Acute myeloid leukemia, Chidamide, Maintenance therapy, Real-world Study
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Use of chidamide-based regimens as maintenance therapy for at least 3 months after the initiation of the maintenance therapy, with chidamide as a dose of 10 mg/day, days 1-14, a 28-day cycle, for at least 6 months. Besides chidamide, the combining agents were record. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRD negativity rate
MRD negativity rate after 6 cycles of maintenance therapy (28 days for one cycle).
Measured: After 6 cycles of 28-day maintenance therapy, an average of 6 months
Secondary outcomes (4)
Duration of remission, DoR
The time from the initiation of maintenance therapy to disease relapse or the last follow-up.
Measured: Through study completion, an average of 1 year
Relapsed-free survival
The period from the initiation of the study to the first recurrence or last follow-up.
Measured: Through study completion, an average of 1 year
Overall survival
Time from the enrollment into the study to death for any reasons and the last follow-up.
Measured: Through study completion, an average of 1 year
Adverse events
The number and proportion of participants with treatment-related hematologic or nonhematologic adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start27 Jul 2026
- Primary completion1 Aug 2026
- Study completion31 Jul 2027 (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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Second Provincial General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, First Affiliated Hospital of Guangxi Medical University, Guangzhou First People's Hospital, Dongguan People's Hospital, Zhongshan People's Hospital, Guangdong, China, Shunde Hospital, Sothen Medical University, Shenzhen Second People's Hospital
- Responsible party
- Principal investigator, Qing Zhang, Guangdong Second Provincial General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822789
- Sponsor's protocol ID
- GD2H-2026-482
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Chidamide in the Maintenance Therapy of High-Risk Acute Myeloid Leukemia Patients: A Multi-center Real-World Study
- ClinicalTrials.gov ID
- NCT07822789
- Acronym / sponsor ID
- GD2H-2026-482
- Conditions
- Acute Myeloid Leukemia, Maintenance Therapy
- Keywords
- Acute myeloid leukemia, Chidamide, Maintenance therapy, Real-world Study
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Guangdong Second Provincial General HospitalUniversity, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, First Affiliated Hospital of Guangxi Medical University, Guangzhou First People's Hospital, Dongguan People's Hospital, Zhongshan People's Hospital, Guangdong, China, Shunde Hospital, Sothen Medical University, Shenzhen Second People's Hospital
- Study start
- 27 Jul 2026 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 16 Sep 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.
Acute myeloid leukemia (AML) patients with fusion gene-positive including core binding factor (CBF), mixed-lineage leukemia (MLL) gene rearrangement have a high incidence of relapse if they have continuously positive measurable residual disease (MRD) or ELN 2022-high risk chromosome abnormality and could not be bridged to allogenetic heamatopoitic stem cell transplantation (allo-HSCT). Histone deacetylase (HDAC) is known to abnormally recruit in these fusion gene-positive AML, and has been proven to be a promising therapy target. Whether HDAC inhibitor chidamide could be used as a maintenance therapy in these AML patients remains unknown. This study aims to evaluate the efficacy and safety of chidamide in the maintenance therapy of high-risk acute myeloid leukemia (AML) patients with core binding factor (CBF) and measurable residual disease (MRD) positivity, or ELN 2022-high risk fusion gene positive.
Detailed description
Despite the above data providing positive signals for the application of chidamide in fusion gene AML, particularly in high-risk patients, there remain significant gaps in the evidence: 1) most supportive data come from combination therapy in relapsed/refractory settings or post-transplant interventions, and systematic studies on its use as a post-remission maintenance therapy after initial induction are still lacking; 2) existing studies related to maintenance therapy are mostly small-sample retrospective analyses, lacking supportive data from prospective, or multi-center, or large scale designs; 3) for the definition of 'high-risk,' especially incorporating 'MRD-positive' as a strong prognostic indicator in patient selection criteria and evaluating the value of maintenance therapy accordingly, research is still insufficient.
Based on the clinical dilemma of high relapse risk after remission in high-risk fusion gene AML patients, and the scientific rationale of chidamide exerting anti-leukemia effects through multiple mechanisms such as correcting epigenetic abnormalities, inducing differentiation, and modulating immunity, combined with its efficacy and safety signals in R/R and post-transplant settings, we propose conducting clinical research on chidamide as maintenance therapy in high-risk fusion gene-positive AML. This study aims to focus on the high-risk patient group who have completed standard induction and consolidation therapy, achieved morphological remission but remain MRD-positive (including CBF-AML and MLL-r AML), who are at extremely high risk of relapse under current standard treatment, and may be unable or not planning to undergo allo-HSCT due to age, comorbidities, or lack of suitable donors. Evaluating whether chidamide as maintenance therapy can effectively clear MRD, reduce relapse rates, prolong disease-free survival and overall survival, and clarify its safety profile in this specific population has significant clinical and scientific value, and is expected to provide a new and effective maintenance therapy option for this high-risk AML population, improving their long-term prognosis.
Therefore, conducting this study is an important exploration responding to urgent clinical needs, continuing the chain of evidence from basic and preclinical studies, and striving to fill the gap in the field of maintenance therapy for high-risk AML.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –Use of chidamide-based regimens as maintenance therapy for at least 3 months after the initiation of the maintenance therapy, with chidamide as a dose of 10 mg/day, days 1-14, a 28-day cycle, for at least 6 months. Besides chidamide, the combining agents were record. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- High-risk patients who had completed standard induction and consolidation therapy and achieved complete remission (CR) or CR with incomplete peripheral blood count recovery (CRi), and could not receive allo-HSCT, and had taken chidamide as maintenance therapy for at least 3 months. High-risk patients were defined as those with CFB-AML and MRD positive, or patients with ELN 2022-high risk fusion genes, such as MLL rearrangement, or NUP98 rearrangement, ect.
Key inclusion criteria (5 listed)
- Age range ≥18 years, both male and female were eligible.
- Patients with CFB-AML and MRD positive, or patients with ELN 2022-high risk fusion genes, such as MLL rearrangement, or NUP98 rearrangement, ect.
- Use of chidamide-based regimens as maintenance therapy for at least 3 months, without undergoing or not planning to undergo allo-HSCT.
- ECOG ≤4;
- At screening, laboratory tests meet the following criteria: (1) Complete blood count: hemoglobin (Hb) ≥90 g/L, absolute neutrophil count (ANC) ≥1.5×10⁹/L, platelet count (PLT) ≥90×10⁹/L; (2) Biochemical tests: serum creatinine (Cr) ≤1.5× upper limit of normal (ULN); total bilirubin (TBIL) ≤1.5×ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (for cases with liver metastasis: ≤5×ULN).
Key exclusion criteria (7 listed)
- Known history of allergy to the study drug.
- Resistant to chidamide.
- Unable to take oral medications.
- Concurrent uncontrolled active infection (including bacterial, fungal, or viral infections).
- Concurrent uncontrolled major organ failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MRD negativity rate
Time frame: After 6 cycles of 28-day maintenance therapy, an average of 6 months
MRD negativity rate after 6 cycles of maintenance therapy (28 days for one cycle).
4 secondary outcomes
Duration of remission, DoR
Time frame: Through study completion, an average of 1 year
Relapsed-free survival
Time frame: Through study completion, an average of 1 year
Overall survival
Time frame: Through study completion, an average of 1 year
Adverse events
Time frame: Through study completion, an average of 1 year
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 16 Sep 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia and Maintenance Therapy, run by Guangdong Second Provincial 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 5 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 16 Sep 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRD negativity rate (time frame: After 6 cycles of 28-day maintenance therapy, an average of 6 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 16 Sep 2026.