AML, AdultNCT06066905
A Study of Chidamide With AZA in MRD Positive AML After Transplant
A study testing chidamide and azacitidine in people with AML, Adult and Minimal Residual Disease, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
acute myeloid leukemia (AML) is a malignant tumor of the hematopoietic system with high heterogeneity in cytogenetics and molecular biology.Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is still the primary treatment option for patients with AML and the most effective method for radical treatment of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AML, Adult, Minimal Residual Disease
- What is being tested?
- chidamide and azacitidine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 26 Oct 2023to Dec 2026
- Phase
- Interventional
- 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
- Patients diagnosed with AML (diagnostic criteria refer to WHO2016 criteria, except M3) can detect small residual lesions (MRD) positive after allogeneic hematopoietic stem cell transplantation (allo-HSCT);
- ≥18 years old;
- ECOG≤3;
- lifespan≥3 months;
- Take contraceptive measures;
- Sign informed consent.
Who cannot join
- Allergic to the study drug;
- A gastrointestinal condition that prevents oral medication;
- active infection;
- Dysfunction of vital organs;
- other malignancies;
- HIV infection;
Show all 11Show fewer
- HBV or HCV;
- The QT interval is prolonged;
- Pregnant or lactating women;
- Is participating in other clinical studies;
- The researchers did not consider it appropriate to participate in this 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
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
WENG jian yu, M.D., （020）83827812, wsswjy@sina.com
About this study
acute myeloid leukemia (AML) is a malignant tumor of the hematopoietic system with high heterogeneity in cytogenetics and molecular biology.Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is still the primary treatment option for patients with AML and the most effective method for radical treatment of AML.Despite considerable progress in allo-HSCT over the past decade, 30%-40% of patients still relapse, and post-transplant relapse remains the leading cause of death in patients with AML.
Read the detailed description
Investigators proposed Chidamide combined with azacitidine as the prospective treatment for MRD-positive AML patients before and after transplantation, hoping to reduce the recurrence rate of transplantation and improve the transplantation effect. The efficacy and safety of the method will be verified by this clinical study.
- Conditions
- AML, Adult, Minimal Residual Disease
- Being tested
- chidamide and azacitidine
- Medical subject headings
- Leukemia, Myeloid, Acute, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chidamide and azacitidineDrug
chidamide：10mg orally,day 1 to day 6 every week, Take it for two weeks, rest for two weeks,so 28 days for a circle, 12 circles totally.
azacitidine:50mg,subcutaneous injection,day 1 to day 5 every week, 28 days for a circle, 6 circles totally.
| Study group | Role | What they receive |
|---|---|---|
| chidamide and azacitidine | Experimental | Not described Receives: Drug: chidamide and azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of RFS in 6 months
relapse-free survival
Measured: 6 months
Secondary outcomes (6)
the rate of MRD turn negative in 6 months
minimal residual disease turn negative
Measured: 6 months
the time length of MRD negative
minimal residual disease negative
Measured: 24 months
the 1 year/2 year RFS
relapse-free survival
Measured: 24 months
the 1 year/2 year OS
overall survival
Measured: 24 months
the rate of GVHD
graft-versus-host disease
Measured: 24 months
Incidence of Treatment-Emergent Adverse Events
Grade 1 to Grade 4 ,according to Common Terminology Criteria for Adverse Events, versions 5.0
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start26 Oct 2023 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AML, AdultStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chipscreen Biosciences, Ltd.
- Responsible party
- Principal investigator, WENG Jian yu, Guangdong Provincial People's Hospital
- Investigators
- WENG jian yu, M.D., Principal investigator, Department of Hematology, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066905
- Sponsor's protocol ID
- Chidaza101
- Status last verified
- Oct 2023
- First submitted
- 19 Sep 2023
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ling W, Wu P, Wu S, Luo C, Huang L, Chen X, Liang X, Li Z, Xu R, Tan J, Wang J, Lai P, Du X, Weng J. MRD-driven HDACi-based therapy post-transplant: a real-world study in high-risk acute myeloid leukemia. Ann Hematol. 2026 Jul 13. doi: 10.1007/s00277-026-07117-7. Online ahead of print.
PubMed 42439986
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Chidamide With AZA in MRD Positive AML After Transplant
- ClinicalTrials.gov ID
- NCT06066905
- Acronym / sponsor ID
- Chidaza101
- Conditions
- AML, Adult, Minimal Residual Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Chipscreen Biosciences, Ltd.
- Study start
- 26 Oct 2023 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Oct 2023 (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) is a malignant tumor of the hematopoietic system with high heterogeneity in cytogenetics and molecular biology.Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is still the primary treatment option for patients with AML and the most effective method for radical treatment of AML.Despite considerable progress in allo-HSCT over the past decade, 30%-40% of patients still relapse, and post-transplant relapse remains the leading cause of death in patients with AML.
Detailed description
Investigators proposed Chidamide combined with azacitidine as the prospective treatment for MRD-positive AML patients before and after transplantation, hoping to reduce the recurrence rate of transplantation and improve the transplantation effect. The efficacy and safety of the method will be verified by this clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chidamide and azacitidine | Experimental | Drug: chidamide and azacitidine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients diagnosed with AML (diagnostic criteria refer to WHO2016 criteria, except M3) can detect small residual lesions (MRD) positive after allogeneic hematopoietic stem cell transplantation (allo-HSCT);
- ≥18 years old;
- ECOG≤3;
- lifespan≥3 months;
- Take contraceptive measures;
Key exclusion criteria (11 listed)
- Allergic to the study drug;
- A gastrointestinal condition that prevents oral medication;
- active infection;
- Dysfunction of vital organs;
- other malignancies;
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 and azacitidinechidamide：10mg orally,day 1 to day 6 every week, Take it for two weeks, rest for two weeks,so 28 days for a circle, 12 circles totally. azacitidine:50mg,subcutaneous injection,day 1 to day 5 every week, 28 days for a circle, 6 circles totally. | Drug | chidamide and azacitidine |
Primary outcome
the rate of RFS in 6 months
Time frame: 6 months
relapse-free survival
6 secondary outcomes
the rate of MRD turn negative in 6 months
Time frame: 6 months
the time length of MRD negative
Time frame: 24 months
the 1 year/2 year RFS
Time frame: 24 months
the 1 year/2 year OS
Time frame: 24 months
the rate of GVHD
Time frame: 24 months
Incidence of Treatment-Emergent Adverse Events
Time frame: 24 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 27 Oct 2023.
- Derived from this study: PubMed 42439986Ling W, Wu P, Wu S, Luo C, Huang L, Chen X, Liang X, Li Z, Xu R, Tan J, Wang J, Lai P, Du X, Weng J. MRD-driven HDACi-based therapy post-transplant: a real-world study in high-risk acute myeloid leukemia. Ann Hematol. 2026 Jul 13. doi: 10.1007/s00277-026-07117-7. Online ahead of print.
- 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.
WENG jian yu, M.D. principal investigator
Department of Hematology, Guangdong Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chidamide and azacitidine in people with AML, Adult and Minimal Residual Disease, run by Guangdong Provincial People's 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 6 inclusion and 11 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 27 Oct 2023. 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?
Contact WENG jian yu, M.D. (020-83827812, wengjianyu1969@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of RFS in 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06066905, which also lists 1 linked publication.
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 27 Oct 2023.