AMLPhase 1/2NCT02886559
Chidamide Plus DCAG for Relapsed/Refractory AML
A Phase 1/2 study testing Chidamide plus DCAG regimen in people with AML and Relapse, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Despite advances in understanding the complexities of acute myeloid leukaemia (AML), the treatment of refractory or relapsed AML (rrAML) remains a daunting clinical challenge.The investigators designed a new regimen, including chidamide, decitabine, aclarubincin, cytarabine and G-CSF, to treat rrAML. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- What is being tested?
- Chidamide plus DCAG regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Jun 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and women whose age more than 18 and less than 59；
- Patients diagnosed as AML according to the 2008 WHO (WHO) myeloid malignant disease diagnosis standard;
- Patients who relapsed after remission or who can not achieve remission after at least two cycle of systemic therapy (including chemotherapy, hematopoietic stem cell transplantation, etc.);
- ECOG performance status 0-3;
- Expected survival time ˃ 3 months;
- Patients without serious hearts, lung, liver, kidney disease;
- Patients have not received radiotherapy, chemotherapy, targeted therapy or hematopoietic stem cell transplantation and other treatment within 4 weeks prior to the enrollment;
- Patients are able to understand and willing to sign informed consent.
Who cannot join
- Patients who allergy to the study drug or the drug with similar chemical structure;;
- Pregnancy, lactation women and women of childbearing age who do not want to practice effective methods of contraception;
- Active infection;
- Drug abuse, long-term alcohol abuse so as to affect the results of the evaluation of patients;
- Patients with mental disorders or other conditions can not obtain informed consent, can not meet the requirements of the study treatment and procedures;
- Patients have clinical significant QTc interval prolongation history (male > 450ms. Female >470ms), ventricular heart had tachycardia (VT) and atrial fibrillation (AF), II degree heart block, myocardial infarction attack (MI) within 1 year prior to the enrollment, congestive heart failure (CHF), patients of coronary heart disease who have clinical symptoms and need drug treatment.
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- Cardiac ultrasound showed that the diastolic pericardial fluid dark area width ˃ 10mm;
- Patients have received organ transplantation;
- Active bleeding
- Patients have new thrombosis, embolism, cerebral hemorrhage and other diseases or medical history of patients within 1 year prior to enrollment;
- The main organs of the surgery is less than 6 weeks;
- Bone marrow hyperplasia and WBC <2.0 * 10^9/L;
- Liver function abnormalities (total bilirubin > 1.5 times of upper limit of normal range , ALT / AST > 2.5 times of the upper limit of normal range or patients with liver involvement whose ALT / AST > 1.5 times of upper limit of normal range), renal anomalies (serum creatinine > 1.5 times of upper limit of normal value );
- Not suitable for the study according to investigator's assessment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China PLA General Hospital
Beijing, 100039
Li Yu, M.D Ph.D, 010-66937644, chunhuiliyu@yahoo.com
Li-Xin Yu
About this study
Despite advances in understanding the complexities of acute myeloid leukaemia (AML), the treatment of refractory or relapsed AML (rrAML) remains a daunting clinical challenge.The investigators designed a new regimen, including chidamide, decitabine, aclarubincin, cytarabine and G-CSF, to treat rrAML.
- Being tested
- Chidamide plus DCAG regimen
- Keywords
- demethylating agent, chidamide
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chidamide plus DCAG regimenDrug
Also called DCCAG regimen
chidamide, decitabine, aclarubicin, cytarabine and G-CSF
| Study group | Role | What they receive |
|---|---|---|
| DCCAG | Experimental | Chidamide 30mg twice for one week decitabine 20mg/m^2 for 5 days Receives: Drug: Chidamide plus DCAG regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate
Measured: 3 months
Secondary outcomes (1)
overall survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2018 (estimated)
- Study completionJun 2019 (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 AMLStudies 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Navy General Hospital, Beijing
- Responsible party
- Principal investigator, Li Yu, Chinese PLA General Hospital
- Investigators
- Li Yu, MD. Ph.D, Study chair, Chinese PLA General HospitalLi-Xin Wang, MD. Ph.D., Principal investigator, Navy General Hospital, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886559
- Sponsor's protocol ID
- CN301-XYK-003
- Status last verified
- Sep 2016
- First submitted
- 29 Aug 2016
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Wang L, Luo J, Chen G, Fang M, Wei X, Li Y, Liu Z, Zhang Y, Gao S, Shen J, Wang X, Gao X, Zhou W, Ma Y, Liu H, Li X, Yang L, Sun K, Yu L. Chidamide, decitabine, cytarabine, aclarubicin, and granulocyte colony-stimulating factor (CDCAG) in patients with relapsed/refractory acute myeloid leukemia: a single-arm, phase 1/2 study. Clin Epigenetics. 2020 Sep 1;12(1):132. doi: 10.1186/s13148-020-00923-4.
PubMed 32873343
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chidamide Plus DCAG for Relapsed/Refractory AML
- ClinicalTrials.gov ID
- NCT02886559
- Acronym / sponsor ID
- CN301-XYK-003
- Keywords
- demethylating agent, chidamide
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Navy General Hospital, Beijing
- Study start
- Jun 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 1 Sep 2016 (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.
Despite advances in understanding the complexities of acute myeloid leukaemia (AML), the treatment of refractory or relapsed AML (rrAML) remains a daunting clinical challenge.The investigators designed a new regimen, including chidamide, decitabine, aclarubincin, cytarabine and G-CSF, to treat rrAML.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DCCAG | Experimental | Drug: Chidamide plus DCAG regimenChidamide 30mg twice for one week decitabine 20mg/m^2 for 5 days |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Men and women whose age more than 18 and less than 59；
- Patients diagnosed as AML according to the 2008 WHO (WHO) myeloid malignant disease diagnosis standard;
- Patients who relapsed after remission or who can not achieve remission after at least two cycle of systemic therapy (including chemotherapy, hematopoietic stem cell transplantation, etc.);
- ECOG performance status 0-3;
- Expected survival time ˃ 3 months;
Key exclusion criteria (14 listed)
- Patients who allergy to the study drug or the drug with similar chemical structure;;
- Pregnancy, lactation women and women of childbearing age who do not want to practice effective methods of contraception;
- Active infection;
- Drug abuse, long-term alcohol abuse so as to affect the results of the evaluation of patients;
- Patients with mental disorders or other conditions can not obtain informed consent, can not meet the requirements of the study treatment and procedures;
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 plus DCAG regimenAlso: DCCAG regimenchidamide, decitabine, aclarubicin, cytarabine and G-CSF | Drug | DCCAG |
Primary outcome
overall response rate
Time frame: 3 months
1 secondary outcome
overall survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
- Derived from this study: PubMed 32873343Wang L, Luo J, Chen G, Fang M, Wei X, Li Y, Liu Z, Zhang Y, Gao S, Shen J, Wang X, Gao X, Zhou W, Ma Y, Liu H, Li X, Yang L, Sun K, Yu L. Chidamide, decitabine, cytarabine, aclarubicin, and granulocyte colony-stimulating factor (CDCAG) in patients with relapsed/refractory acute myeloid leukemia: a single-arm, phase 1/2 study. Clin Epigenetics. 2020 Sep 1;12(1):132. doi: 10.1186/s13148-020-00923-4.
- Individual participant dataSharing planned: Yes
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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.
Li Yu, MD. Ph.D study chair
Chinese PLA General Hospital
Li-Xin Wang, MD. Ph.D. principal investigator
Navy General Hospital, Beijing, 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 Chidamide plus DCAG regimen in people with AML and Relapse, run by Chinese PLA 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 8 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: status not confirmed, as of the sponsor's last update on 14 Feb 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li-Xin Wang, MD. Ph.D. (086-010-66957676, wanglixin1991@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate (time frame: 3 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 NCT02886559, 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 14 Feb 2018.