Leukemia, Myeloid, AcutePhase 1/2NCT05270200
Single Arm Study of Post-transplant Azacitidine and Chidamide for Prevention of Acute Myelogenous Leukemia Relapse
A Phase 1/2 study testing Azacitidine and Chidamide in people with Leukemia, Myeloid, Acute, run by Zhujiang Hospital at 1 site in China.
Trial summary
The goal of this clinical research study is to learn if azacitidine combined with Chidamide will help to control the disease in patients with high-risk AML after an allogeneic stem cell transplant. The safety of this combination will also be studied. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Leukemia, Myeloid, Acute
- What is being tested?
- Azacitidine and Chidamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2022to 31 Dec 2027
- Phase
- Phase 1/2
- 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
- 1.Age 18 to 60 years old,both male and female
- 2.Be able to understand and sign informed consent
- 3.Patients with a diagnosis of AML not M3 according to the 2016 World Health Organization (WHO) Acute Myeloid Leukemia Classification and Diagnostic
- 4.Patients have AML with poor genetic abnormalities,primary refractory AML,relapsed AML or secondary AML
- 5.Patients with an ECOG performance status 0,1,2 or 3
- 6.Expected survival time ≥ 3 months
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- 7.Non-hematological toxicity related to transplantation does not exceed Grade 2
- 8.Laboratory indicators meet the following standards:
- 7 days before the first day of the first course of treatment, bilirubin, ALT and AST were all less than 3 times the upper limit of normal.
- Measure twice within 7 days before the first day of the first course of treatment, at least 2 days apart, the neutrophil count are greater than 1.5×10/L and without G-CSF treatment.
- Measure twice within 7 days before the first day of the first course of treatment, at least 2 days apart, platelet count greater than 80×10/L and without platelet transfusion.
- Serum creatinine clearance rate is greater than 30ml/min.
Who cannot join
- 1.Uncontrollable active infection
- 2.Patients with active hepatitis B or C or HIV infection before enrollment
- 3.Have a grade III-IV graft-versus-host disease
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
Nanfang Hospital of Southern Medical University
Guanzhou, Guandong, 510250
Rui Huang, Doctor, +8615918528317, Rachelchn@163.com
Yunqing Wang, Bachelor, +8618585509970, Wangyun7q@163.com
About this study
Official title: To Evaluate Safety and Efficiency of AZA Combined With Chidamide as Maintenance Therapy in High-risk Acute Myeloid Leukemia Patients After Allogeneic Hematopoietic Stem Cell Transplantation：A Multicenter, Single-arm Study
The goal of this clinical research study is to learn if azacitidine combined with Chidamide will help to control the disease in patients with high-risk AML after an allogeneic stem cell transplant. The safety of this combination will also be studied.
Read the detailed description
The Study Drug:
Azacitidine is designed to block certain genes in cancer cells whose job is to stop the function of the tumor-fighting genes. By blocking the "bad" genes, the tumor-fighting genes may be able to work better.
Chidamide exhibits potent inhibitory effect on cell viability of MDS and AML cells, and the possible mechanism may lie in the downregulation of JAK2/STAT3 signaling through SOCS3 upregulation.
Study Group： If you are found to be eligible to take part in this study,you will receive azacitidine and chidamide.
Study Drug Administration:
You will recieve six courses of azacitidine through a needle under your skin on Days 1-3.Each course is 28 days long.At the same time you will recieve oral chidamide per day for no more than 2 years.
The treatment will start after 30 days post-transplantation and your neutrophil count is of 1.5 × 10⁹ cells per L or higher and non-transfused platelets is of 80 × 10⁹ per L or higher.
The treatment would stop if neutrophil count is less than 0.5 × 10⁹ cells per L or platelets is less than 50 × 10⁹ per L.And it would also stop when grade 3/4 non-hematological adverse events happened.
Study Visit:
You may come back for study visits every month in a year when the treatment start.
Blood and urine will be drawn for routine tests every month. At 1,2,3,4,5,6,9 and 12 months,You will have a bone marrow aspiration to check the status of the disease.
You will have a electrocardiiogram test every 3 months to check the heart function.
Length of Study:
You will be on study treatment for up to 1 year.You will be taken off study early if you experience intolerable side effects or the disease gets worse.
End-of-Treatment Visit:
If you complete the planned treatment with azacitidine and chidamide, you will have an end-of-treatment visit:
Blood and urine will be drawn for routine tests. You will have a bone marrow aspiration to check the status of the disease. You will have a electrocardiiogram test every 3 months to check the heart function.
This is an investigational study. Azacitidine and chidamide are FDA approved and are commercially available for the treatment of acute leukemia.
- Conditions
- Leukemia, Myeloid, Acute
- Being tested
- Azacitidine, Chidamide
- Keywords
- Acute myelogenous leukemia, Allogenetic stem cell transplant, Maintenance therapy, Azacitidine, Chidamide, High-risk AML
- 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.
AzacitidineDrug
Also called 5-Azacitidine, 5-aza, Vidaza, 5-AZC
Patients will recieve six courses of azacitidine 50mg/m2 through a needle under skin on Days 1-3.Each course is 28 days long.
ChidamideDrug
Also called Epidaza
Patients will recieve oral chidamide 5mg per day for no more than 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Azacitidine combined with Chidamide | Experimental | Patients will recieve six courses of azacitidine 50mg/m2 through a needle under your skin on Days 1-3.Each course is 28 days long.At the same time patients will recieve oral chidamide 5mg per day for no more than 2 years. Receives: Drug: Azacitidine; Drug: Chidamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Paticipants With Adverse Events as a Measure of Safety
Safety were measured with respect to:
- Safety measurements
- Incidence of adverse events
Measured: From the day of stem cell transplantation to one year after stem cell transplantation
One year cumulative incidence of relapse
Leukemia relapse base on morphoogy criterion
Measured: From the day of stem cell transplantation to one year after stem cell transplantation
Secondary outcomes (3)
Relapes-free Survival（RFS）
The time that a participant survives without relapes of the disease
Measured: From the day of stem cell transplantation to one year after stem cell transplantation
Overall survival（OS）
The time that a participant survives without death
Measured: From the day of stem cell transplantation to one year after stem cell transplantation
The cumulative Incidence rate of GVHD
acute GVHD and chronic GVHD diagnosis based on MIH criterion
Measured: From the day of stem cell transplantation to one year after stem cell transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start1 Feb 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 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 Zhujiang HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rui Huang, Doctor, Principal investigator, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270200
- Sponsor's protocol ID
- AZA+Chidamide
- Status last verified
- Feb 2026
- First submitted
- 20 Jan 2022
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share our data within 6 months after the end of the trial. You can ask us for data or obtain it on the Clinical Trial Management Public Platform of clinical trial.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate Safety and Efficiency of AZA Combined With Chidamide as Maintenance Therapy in High-risk Acute Myeloid Leukemia Patients After Allogeneic Hematopoietic Stem Cell Transplantation：A Multicenter, Single-arm Study
- ClinicalTrials.gov ID
- NCT05270200
- Acronym / sponsor ID
- AZA+Chidamide
- Conditions
- Leukemia, Myeloid, Acute
- Keywords
- Acute myelogenous leukemia, Allogenetic stem cell transplant, Maintenance therapy, Azacitidine, Chidamide, High-risk AML
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 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 goal of this clinical research study is to learn if azacitidine combined with Chidamide will help to control the disease in patients with high-risk AML after an allogeneic stem cell transplant. The safety of this combination will also be studied.
Detailed description
The Study Drug:
Azacitidine is designed to block certain genes in cancer cells whose job is to stop the function of the tumor-fighting genes. By blocking the "bad" genes, the tumor-fighting genes may be able to work better.
Chidamide exhibits potent inhibitory effect on cell viability of MDS and AML cells, and the possible mechanism may lie in the downregulation of JAK2/STAT3 signaling through SOCS3 upregulation.
Study Group： If you are found to be eligible to take part in this study,you will receive azacitidine and chidamide.
Study Drug Administration:
You will recieve six courses of azacitidine through a needle under your skin on Days 1-3.Each course is 28 days long.At the same time you will recieve oral chidamide per day for no more than 2 years.
The treatment will start after 30 days post-transplantation and your neutrophil count is of 1.5 × 10⁹ cells per L or higher and non-transfused platelets is of 80 × 10⁹ per L or higher.
The treatment would stop if neutrophil count is less than 0.5 × 10⁹ cells per L or platelets is less than 50 × 10⁹ per L.And it would also stop when grade 3/4 non-hematological adverse events happened.
Study Visit:
You may come back for study visits every month in a year when the treatment start.
Blood and urine will be drawn for routine tests every month. At 1,2,3,4,5,6,9 and 12 months,You will have a bone marrow aspiration to check the status of the disease.
You will have a electrocardiiogram test every 3 months to check the heart function.
Length of Study:
You will be on study treatment for up to 1 year.You will be taken off study early if you experience intolerable side effects or the disease gets worse.
End-of-Treatment Visit:
If you complete the planned treatment with azacitidine and chidamide, you will have an end-of-treatment visit:
Blood and urine will be drawn for routine tests. You will have a bone marrow aspiration to check the status of the disease. You will have a electrocardiiogram test every 3 months to check the heart function.
This is an investigational study. Azacitidine and chidamide are FDA approved and are commercially available for the treatment of acute leukemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Azacitidine combined with Chidamide | Experimental | Drug: Azacitidine, Drug: ChidamidePatients will recieve six courses of azacitidine 50mg/m2 through a needle under your skin on Days 1-3.Each course is 28 days long.At the same time patients will recieve oral chidamide 5mg per day for no more than 2 years. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 1.Age 18 to 60 years old,both male and female
- 2.Be able to understand and sign informed consent
- 3.Patients with a diagnosis of AML not M3 according to the 2016 World Health Organization (WHO) Acute Myeloid Leukemia Classification and Diagnostic
- 4.Patients have AML with poor genetic abnormalities,primary refractory AML,relapsed AML or secondary AML
- 5.Patients with an ECOG performance status 0,1,2 or 3
Key exclusion criteria (3 listed)
- 1.Uncontrollable active infection
- 2.Patients with active hepatitis B or C or HIV infection before enrollment
- 3.Have a grade III-IV graft-versus-host 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 |
|---|---|---|
| AzacitidineAlso: 5-Azacitidine, 5-aza, Vidaza, 5-AZCPatients will recieve six courses of azacitidine 50mg/m2 through a needle under skin on Days 1-3.Each course is 28 days long. | Drug | Azacitidine combined with Chidamide |
| ChidamideAlso: EpidazaPatients will recieve oral chidamide 5mg per day for no more than 2 years. | Drug | Azacitidine combined with Chidamide |
Primary outcome
Number of Paticipants With Adverse Events as a Measure of Safety
Time frame: From the day of stem cell transplantation to one year after stem cell transplantation
Safety were measured with respect to: 1. Safety measurements 2. Incidence of adverse events
One year cumulative incidence of relapse
Time frame: From the day of stem cell transplantation to one year after stem cell transplantation
Leukemia relapse base on morphoogy criterion
3 secondary outcomes
Relapes-free Survival（RFS）
Time frame: From the day of stem cell transplantation to one year after stem cell transplantation
Overall survival（OS）
Time frame: From the day of stem cell transplantation to one year after stem cell transplantation
The cumulative Incidence rate of GVHD
Time frame: From the day of stem cell transplantation to one year after stem cell transplantation
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 7 Jul 2026.
- Individual participant dataSharing planned: Yes. We will share our data within 6 months after the end of the trial. You can ask us for data or obtain it on the Clinical Trial Management Public Platform of clinical trial.
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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.
Rui Huang, Doctor principal investigator
Zhujiang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Azacitidine and Chidamide in people with Leukemia, Myeloid, Acute, run by Zhujiang 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 12 inclusion and 3 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 7 Jul 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Rui Huang, Doctor (+8615918528317, Rachelchn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Paticipants With Adverse Events as a Measure of Safety (time frame: From the day of stem cell transplantation to one year after stem cell transplantation). 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 7 Jul 2026.