Allogeneic Hematopoietic Cell Transplantation (HCT)Phase 2CM-AML-001NCT07304232
Post-transplantation Maintenance Therapy With Cidabenamide in Patients With Intermediate/High-risk AML
A Phase 2 study testing Chidamide in people with Allogeneic Hematopoietic Cell Transplantation (HCT) and AML (Acute Myeloid Leukemia), run by Institute of Hematology & Blood Diseases Hospital, China at 5 sites in China.
Trial summary
This study is a Phase II clinical trial designed to evaluate the efficacy and safety of Chidamide as maintenance therapy in high-risk acute myeloid leukemia (AML) patients following stem cell transplantation. Trial Design: The trial is a single-arm, open-label study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Allogeneic Hematopoietic Cell Transplantation (HCT), AML (Acute Myeloid Leukemia)
- What is being tested?
- Chidamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 5 sitesChina
- Study dates
- 1 Sep 2025to 31 Dec 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AML patients meeting the following conditions (diagnosed per WHO 2022 AML criteria) who achieved first complete remission (CR) with intermediate-/high-risk cytogenetic abnormalities at the time of allogeneic transplantation.
- Patients must achieve complete remission (CR) post-transplantation.
- Enrollment must occur between 60 and 100 days after transplantation.
- Age 18 to 75 years.
- ECOG performance status 0-1.
- Serum creatinine < 1.5 × ULN (upper limit of normal).
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- Serum direct bilirubin < 1.5 mg/dL (except in Gilbert's syndrome).
- ALT and AST < 2.5 × ULN.
- Ability to understand and provide written informed consent.
Who cannot join
- Receipt of any other investigational drugs post-transplantation.
- FLT3 mutation-positive status.
- Central nervous system (CNS) involvement.
- Uncontrolled grade 2-4 graft-versus-host disease (GVHD).
- Uncontrolled active infection.
- Known or suspected hypersensitivity to Chidamide or its excipients.
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- Uncontrolled congestive heart failure (CHF) or other concomitant systemic diseases or severe complications that, in the investigator's judgment, would make the patient unsuitable for participation in this study or would significantly compromise the proper assessment of the safety and toxicity of the prescribed regimen.
- Pregnancy or breastfeeding.
- Any other condition that, in the investigator's judgment, would make the patient unsuitable for participation in this study.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Not yet recruiting
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
Shengjin Fan
- Not yet recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Fuxu Wang
- Recruiting
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020
- Not yet recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300020
Lijuan Li
- Not yet recruiting
Tianjin People's Hospital
Tianjin, Tianjin Municipality, 300020
Xingli Zhao, insectzhao@163.com
About this study
Official title: Multicentre, Phase II Clinical Study of Post-transplantation Maintenance Therapy With Cidabenamide in Patients With Intermediate/High-risk AML
This study is a Phase II clinical trial designed to evaluate the efficacy and safety of Chidamide as maintenance therapy in high-risk acute myeloid leukemia (AML) patients following stem cell transplantation.
Trial Design: The trial is a single-arm, open-label study. The experimental group plans to enroll 67 patients, while the control group (observation only) also plans to enroll approximately 67 patients, with randomization. All patients must have received induction chemotherapy prior to enrollment and may or may not have received consolidation therapy. The chemotherapy regimen was determined by the treating physician. Patients had received induction and/or consolidation therapy, achieved remission, and underwent stem cell transplantation.
Study Objectives: The study aims to assess the impact of Chidamide maintenance therapy on recurrence-free survival (RFS), overall survival (OS), and the duration of complete remission. The study will also evaluate the tolerability and toxicity profile of this regimen, as well as the effect of maintenance therapy on the dynamics of minimal residual disease (MRD).
Read the detailed description
Chidamide : 10 mg/day, orally once daily (QD) on days 1-5 per week. During the study, the dose of chidamide may be adjusted at the physician's discretion to 5 mg/day. Each treatment cycle consists of 28 days. Treatment will continue indefinitely, with interruptions and dose adjustments implemented as needed to manage toxicity. Subjects will continue receiving the assigned treatment per investigator assessment for a maximum of 24 months, until documented disease progression, intolerable toxicity, withdrawal of consent, or meeting other protocol-specified criteria for treatment discontinuation (whichever occurs first). Patients who continue to derive clinical benefit, as discussed and agreed upon with the principal investigator, may remain in the study even in the event of relapse (if deemed clinically non-significant).
- Being tested
- Chidamide
- 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.
ChidamideDrug
Patients in the experimental group receive Chidamide at a dose of 10 mg/day, administered orally for the first 5 days of each week, followed by a 2-day treatment-free interval.
| Study group | Role | What they receive |
|---|---|---|
| Chidamide treatment group | Experimental | Patients in the experimental group receive Chidamide at a dose of 10 mg/day, administered orally for the first 5 days of each week, followed by a 2-day treatment-free interval. Receives: Drug: Chidamide |
| Observation group | No intervention | Observation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-Free Survival(RFS)
the rate from first dose administration until the first achievement of complete remission (CR) or complete remission with incomplete recovery (CRi), followed by either confirmed relapse or death from any cause, whichever occurs earlier.
Measured: 2years
Secondary outcomes (5)
Overall Survival (OS)
the 2-year survival rate since receiving maintenance treatment with Chidamide to death from any causes
Measured: 2years
Event-Free Survival (EFS)
the 2-year event-free survival since receiving maintenance treatment with Chidamide to death from any causes
Measured: 2years
Duration of Response (CRd)
the duration of remission in AML patients receiving maintenance treatment with Chidamide
Measured: 2years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.The frequency and severity of adverse events were evaluated based on changes in various vital sign indicators and laboratory tests.
Measured: 2years
Minor residual lesions (MRD) Response Rate
Defined as the presence of less than 0.1% residual blast cells per white blood cell, measured via bone marrow examination. Other thresholds may also be explored and correlated with efficacy outcomes. Subjects who are randomized but do not undergo MRD assessment will be considered non-responders for the MRD response rate analysis.
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start1 Sep 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic Hematopoietic Cell Transplantation (HCT)Studies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304232
- Sponsor's protocol ID
- IIT2025057
- Acronym
- CM-AML-001
- Status last verified
- Sep 2025
- First submitted
- 5 Sep 2025
- Last updated
- 26 Dec 2025
- 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 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Phase II Clinical Study of Post-transplantation Maintenance Therapy With Cidabenamide in Patients With Intermediate/High-risk AML
- ClinicalTrials.gov ID
- NCT07304232
- Acronym / sponsor ID
- CM-AML-001 / IIT2025057
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 26 Dec 2025 (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.
This study is a Phase II clinical trial designed to evaluate the efficacy and safety of Chidamide as maintenance therapy in high-risk acute myeloid leukemia (AML) patients following stem cell transplantation.
Trial Design: The trial is a single-arm, open-label study. The experimental group plans to enroll 67 patients, while the control group (observation only) also plans to enroll approximately 67 patients, with randomization. All patients must have received induction chemotherapy prior to enrollment and may or may not have received consolidation therapy. The chemotherapy regimen was determined by the treating physician. Patients had received induction and/or consolidation therapy, achieved remission, and underwent stem cell transplantation.
Study Objectives: The study aims to assess the impact of Chidamide maintenance therapy on recurrence-free survival (RFS), overall survival (OS), and the duration of complete remission. The study will also evaluate the tolerability and toxicity profile of this regimen, as well as the effect of maintenance therapy on the dynamics of minimal residual disease (MRD).
Detailed description
Chidamide : 10 mg/day, orally once daily (QD) on days 1-5 per week. During the study, the dose of chidamide may be adjusted at the physician's discretion to 5 mg/day. Each treatment cycle consists of 28 days. Treatment will continue indefinitely, with interruptions and dose adjustments implemented as needed to manage toxicity. Subjects will continue receiving the assigned treatment per investigator assessment for a maximum of 24 months, until documented disease progression, intolerable toxicity, withdrawal of consent, or meeting other protocol-specified criteria for treatment discontinuation (whichever occurs first). Patients who continue to derive clinical benefit, as discussed and agreed upon with the principal investigator, may remain in the study even in the event of relapse (if deemed clinically non-significant).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chidamide treatment group | Experimental | Drug: ChidamidePatients in the experimental group receive Chidamide at a dose of 10 mg/day, administered orally for the first 5 days of each week, followed by a 2-day treatment-free interval. |
| Observation group | No intervention | –Observation group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- AML patients meeting the following conditions (diagnosed per WHO 2022 AML criteria) who achieved first complete remission (CR) with intermediate-/high-risk cytogenetic abnormalities at the time of allogeneic transplantation.
- Patients must achieve complete remission (CR) post-transplantation.
- Enrollment must occur between 60 and 100 days after transplantation.
- Age 18 to 75 years.
- ECOG performance status 0-1.
Key exclusion criteria (9 listed)
- Receipt of any other investigational drugs post-transplantation.
- FLT3 mutation-positive status.
- Central nervous system (CNS) involvement.
- Uncontrolled grade 2-4 graft-versus-host disease (GVHD).
- Uncontrolled active infection.
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 |
|---|---|---|
| ChidamidePatients in the experimental group receive Chidamide at a dose of 10 mg/day, administered orally for the first 5 days of each week, followed by a 2-day treatment-free interval. | Drug | Chidamide treatment group |
Primary outcome
Recurrence-Free Survival(RFS)
Time frame: 2years
the rate from first dose administration until the first achievement of complete remission (CR) or complete remission with incomplete recovery (CRi), followed by either confirmed relapse or death from any cause, whichever occurs earlier.
5 secondary outcomes
Overall Survival (OS)
Time frame: 2years
Event-Free Survival (EFS)
Time frame: 2years
Duration of Response (CRd)
Time frame: 2years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 2years
Minor residual lesions (MRD) Response Rate
Time frame: 2years
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 26 Dec 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chidamide in people with Allogeneic Hematopoietic Cell Transplantation (HCT) and AML (Acute Myeloid Leukemia), run by Institute of Hematology & Blood Diseases Hospital, China at 5 sites 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 9 inclusion and 9 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 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 Jiang Erlie, doctor (+86-15122538106, jiangerlie@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-Free Survival(RFS) (time frame: 2years). 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 26 Dec 2025.