AMLPhase 1/2NCT03031262
Efficacy and Safety of Chidamide in CBF Leukemia
A Phase 1/2 study testing Cytarabine and Chidamide in people with AML, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
In this open-label, randomized, prospective clinical trial, CBF acute myeloid leukemia (AML) patients who have reached CR are randomised into two groups and receive high-dose cytarabine (HDAC) or high-dose cytarabine plus chidamide.The safety and efficacy of chidamide is evaluated. Read more about this study
- Who is it for?
- Ages 14 to 55 years
- Conditions the study is for
- AML
- What is being tested?
- Cytarabine and Chidamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 8 Feb 2017to 30 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 14 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age of 14 to 55 years old;
- Patients that meet the diagnostic criteria(WHO 2008 criteria) of AML (except APL subtypes) and with AML1-ETO or CBF-MYH11 mutation.
- Reached CR after induction regimen.
- ECOG score of ≤ 2;
- Patients with eligible laboratory examination including liver,renal and heart function.
- Adult patients are willing to participate in the study and sign the informed consent by themselves or by their immediate family. Patients under 18 years old willing to participate should have their legal guardians sign the informed consent.
Who cannot join
- Secondary leukemia.
- Patients had other tumor at active stage or had received radiotherapy or chemotherapy in the last 6 months due to other tumor.
- Patients with other blood diseases(for example, haemophiliacs) are excluded.However, patients with abnormal blood count, but with undiagnosed MDS or MPD patients are included.
- Acute panmyelosis with myelofibrosis and myeloid sarcoma patients;
- With BCR-ABL fusion gene;
- Pregnant or lactating women;
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- With ineligible renal or liver function;
- With active cardiovascular disease;
- Severe infection disease including uncured tuberculosis pulmonary aspergillosis;
- AIDS;
- Patients had central nervous system involvement when they were diagnosed as AML.
- Patients with epilepsy or dementia or other mental disease who couldn't understand or follow the research.
- Drugs, medical, mental or social situation may distract patients from following the research or being evaluated the results.
- Patients with other factors which were considered unsuitable to participate in the study by the investigators.
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality
About this study
In this open-label, randomized, prospective clinical trial, CBF acute myeloid leukemia (AML) patients who have reached CR are randomised into two groups and receive high-dose cytarabine (HDAC) or high-dose cytarabine plus chidamide.The safety and efficacy of chidamide is evaluated.
Read the detailed description
In this open-label, randomized, prospective clinical trial, CBF AML(including AML1-ETO or CBF-MYH11 mutated patients) patients who have reached CR are randomised into two groups and receive HDAC or high dose of cytarabine plus chidamide.
In experimental group, patients receive cytarabine at a dose of 3g/㎡/d on the first, third and fifth day and chidamide at a dose of 20mg/d twice a week for 3 months.Patients in control group only receive cytarabine at the same dose.
The safety and efficacy of chidamide is evaluated. The primary outcome is relapse-free survival rate after treatment.
- Conditions
- AML
- Being tested
- Cytarabine, Chidamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytarabineDrug
Also called HDAC
Cytarabine at a dose of 3g/㎡/d on the first, third and fifth day.
ChidamideDrug
Chidamide at a dose of 20mg/d twice a week for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| High Dose of Cytarabine | Active comparator | CBF Patients who reach CR after reduction therapy receive high dose of cytarabine. Receives: Drug: Cytarabine |
| HDAC + Chidamide | Experimental | CBF Patients who reach CR after reduction therapy receive high dose of cytarabine plus chidamide. Receives: Drug: Cytarabine; Drug: Chidamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-Free Survival Rate (RFS)
RFS is defined as the time from the date of complete remission (CR) after entry in this trial until the date of documented relapse or death for CBF positive leukemia patients who achieve CR.
Measured: Within 5 years after randomization
Secondary outcomes (3)
Non-relapse Mortality
Measured: through treatment completion, an average of 5 months
Overall Survival Rate (OS)
Measured: Within 5 years after randomization
Cumulative incidence of relapse
Measured: Within 5 years after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study start8 Feb 2017
- Primary completion10 Apr 2025
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMLStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianxiang Wang, Dr, Principal investigator, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031262
- Sponsor's protocol ID
- IIT2016007（Chidamide）
- Status last verified
- Feb 2025
- First submitted
- 12 Jan 2017
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Chidamide in CBF Leukemia
- ClinicalTrials.gov ID
- NCT03031262
- Acronym / sponsor ID
- IIT2016007（Chidamide）
- Conditions
- AML
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 25 Jan 2017 (estimated)
- 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.
In this open-label, randomized, prospective clinical trial, CBF acute myeloid leukemia (AML) patients who have reached CR are randomised into two groups and receive high-dose cytarabine (HDAC) or high-dose cytarabine plus chidamide.The safety and efficacy of chidamide is evaluated.
Detailed description
In this open-label, randomized, prospective clinical trial, CBF AML(including AML1-ETO or CBF-MYH11 mutated patients) patients who have reached CR are randomised into two groups and receive HDAC or high dose of cytarabine plus chidamide.
In experimental group, patients receive cytarabine at a dose of 3g/㎡/d on the first, third and fifth day and chidamide at a dose of 20mg/d twice a week for 3 months.Patients in control group only receive cytarabine at the same dose.
The safety and efficacy of chidamide is evaluated. The primary outcome is relapse-free survival rate after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Dose of Cytarabine | Active comparator | Drug: CytarabineCBF Patients who reach CR after reduction therapy receive high dose of cytarabine. |
| HDAC + Chidamide | Experimental | Drug: Cytarabine, Drug: ChidamideCBF Patients who reach CR after reduction therapy receive high dose of cytarabine plus chidamide. |
Who may qualify
- Ages
- 14 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age of 14 to 55 years old;
- Patients that meet the diagnostic criteria(WHO 2008 criteria) of AML (except APL subtypes) and with AML1-ETO or CBF-MYH11 mutation.
- Reached CR after induction regimen.
- ECOG score of ≤ 2;
- Patients with eligible laboratory examination including liver,renal and heart function.
Key exclusion criteria (14 listed)
- Secondary leukemia.
- Patients had other tumor at active stage or had received radiotherapy or chemotherapy in the last 6 months due to other tumor.
- Patients with other blood diseases(for example, haemophiliacs) are excluded.However, patients with abnormal blood count, but with undiagnosed MDS or MPD patients are included.
- Acute panmyelosis with myelofibrosis and myeloid sarcoma patients;
- With BCR-ABL fusion gene;
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 |
|---|---|---|
| CytarabineAlso: HDACCytarabine at a dose of 3g/㎡/d on the first, third and fifth day. | Drug | HDAC + Chidamide, High Dose of Cytarabine |
| ChidamideChidamide at a dose of 20mg/d twice a week for 3 months. | Drug | HDAC + Chidamide |
Primary outcome
Relapse-Free Survival Rate (RFS)
Time frame: Within 5 years after randomization
RFS is defined as the time from the date of complete remission (CR) after entry in this trial until the date of documented relapse or death for CBF positive leukemia patients who achieve CR.
3 secondary outcomes
Non-relapse Mortality
Time frame: through treatment completion, an average of 5 months
Overall Survival Rate (OS)
Time frame: Within 5 years after randomization
Cumulative incidence of relapse
Time frame: Within 5 years after randomization
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 30 May 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. This study is not recruiting at the moment.
Jianxiang Wang, Dr principal investigator
Institute of Hematology & Blood Diseases Hospital, China
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 Cytarabine and Chidamide in people with AML, run by Institute of Hematology & Blood Diseases Hospital, China 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 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: under way, not looking for participants, as of the sponsor's last update on 30 May 2025. 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?
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?
Relapse-Free Survival Rate (RFS) (time frame: Within 5 years after randomization). 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 30 May 2025.