AMLPhase 1/2NCT03021395
Efficacy of Decitabine in Clearance of MRD
A Phase 1/2 study testing Decitabine in people with AML, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
In this open-label, prospective clinical trial, the investigators enrolled acute myeloid leukemia (AML) patients after consolidation therapy. Patients with minimal residual disease (MRD) receive decitabine treatment if patients do not receive stem cell transplantation. Read more about this study
- Who is it for?
- Ages 14 to 55 years
- Conditions the study is for
- AML
- What is being tested?
- Decitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 8 Feb 2017to Dec 2022
- 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 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 after consolidation regimen.
- Patients who had received induction and consolation therapy and reached CR.
- 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, 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, prospective clinical trial, the investigators enrolled acute myeloid leukemia (AML) patients after consolidation therapy. Patients with minimal residual disease (MRD) receive decitabine treatment if patients do not receive stem cell transplantation. The MRD clearance rate is the primary outcome to measure the efficacy of decitabine regimen.
Read the detailed description
In this open-label, prospective clinical trial, acute myeloid leukemia (AML) patients after consolidation therapy are enrolled. Patients with minimal residual disease (MRD) after consolidation therapy receive decitabine treatment if patients do not receive stem cell transplantation. The treatment regimen includes three course of decitabine regimen at a dose of 20mg/m² on day1-5. The MRD clearance rate is the primary outcome to measure the efficacy of decitabine regimen.
- Conditions
- AML
- Being tested
- Decitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DecitabineDrug
Decitabine at a dose of 20mg/㎡/d on day 1-5.
| Study group | Role | What they receive |
|---|---|---|
| MRD-positive | Experimental | MRD-positive patients receive Decitabine regimen. Receives: Drug: Decitabine |
| MRD-negative | No intervention | MRD-negative patients receive no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRD Clearance Rate
MRD Clearance Rate is defined as the ratio patients that transform from MRD-positive to MRD-negative after treatment in all of the MRD-positive patients.
Measured: Within 6 months after decitabine treatment
Secondary outcomes (3)
Non-relapse Mortality
Measured: Within 5 years after treatment
Overall Survival Rate (OS)
Measured: Within 5 years after treatment
Cumulative incidence of relapse
Measured: Within 5 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study start8 Feb 2017
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: No participants enrolled
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
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
- NCT03021395
- Sponsor's protocol ID
- IIT2016007（Decitabine）
- Status last verified
- Mar 2019
- 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 of Decitabine in Clearance of MRD
- ClinicalTrials.gov ID
- NCT03021395
- Acronym / sponsor ID
- IIT2016007（Decitabine）
- Conditions
- AML
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 13 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, prospective clinical trial, the investigators enrolled acute myeloid leukemia (AML) patients after consolidation therapy. Patients with minimal residual disease (MRD) receive decitabine treatment if patients do not receive stem cell transplantation. The MRD clearance rate is the primary outcome to measure the efficacy of decitabine regimen.
Detailed description
In this open-label, prospective clinical trial, acute myeloid leukemia (AML) patients after consolidation therapy are enrolled. Patients with minimal residual disease (MRD) after consolidation therapy receive decitabine treatment if patients do not receive stem cell transplantation. The treatment regimen includes three course of decitabine regimen at a dose of 20mg/m² on day1-5. The MRD clearance rate is the primary outcome to measure the efficacy of decitabine regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRD-positive | Experimental | Drug: DecitabineMRD-positive patients receive Decitabine regimen. |
| MRD-negative | No intervention | –MRD-negative patients receive no intervention. |
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 after consolidation regimen.
- Patients who had received induction and consolation therapy and reached CR.
- 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, 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 |
|---|---|---|
| DecitabineDecitabine at a dose of 20mg/㎡/d on day 1-5. | Drug | MRD-positive |
Primary outcome
MRD Clearance Rate
Time frame: Within 6 months after decitabine treatment
MRD Clearance Rate is defined as the ratio patients that transform from MRD-positive to MRD-negative after treatment in all of the MRD-positive patients.
3 secondary outcomes
Non-relapse Mortality
Time frame: Within 5 years after treatment
Overall Survival Rate (OS)
Time frame: Within 5 years after treatment
Cumulative incidence of relapse
Time frame: Within 5 years after treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
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 Decitabine 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: withdrawn, 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
MRD Clearance Rate (time frame: Within 6 months after decitabine treatment). 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; AzTrials last refreshed its copy on 7 Nov 2026.