Acute Myeloid LeukemiaPhase 2NCT06379360
Maintenance Therapy of Hypomethylating Agent (HMA) in Favorable Risk Acute Myeloid Leukemia (AML) Patients
A Phase 2 study testing Hypomethylating agent, Azacitidine or Decitabine in people with Acute Myeloid Leukemia, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
HMA maintenance therapy is expected to benefit overall survival (OS) and relapse free survival (RFS) in AML patients with favorable risk. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Hypomethylating agent, Azacitidine or Decitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aged ≥16 years;
- Patients diagnosed with AML and categorized into favorable-risk group according to European LeukemiaNet (ELN) 2017;
- Patients achieved remission after induction therapy and completed at least 3 cycles of high-dose cytarabine-based consolidation therapy, remaining in FCM-MRD-negative remission at enrollment. FCM-MRD was assessed by multiparameter flow cytometry, in accordance with expert consensus from China, with MRD positivity defined as ≥0.1%.
- Patients not receiving hematopoietic stem cell transplantation prior to enrollment;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
- Expected survival time ≥ 3 months;
- No serious heart, lung, liver or kidney disease;
- Have the ability to understand and be willing to sign the informed consent form for this trial.
Who cannot join
- Patients experienced hematologic relapse before recruitment.
- Patients who are allergic to the study drug or drugs with similar chemical structures.
- Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception.
- Active infection.
- Active bleeding.
- Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment.
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- Patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met.
- Liver function abnormalities (total bilirubin > 1.5 times the upper limit of the normal range, Alanine Aminotransferase (ALT) / Aspartate Aminotransferase (AST) > 2.5 times the upper limit of the normal range or patients with liver involvement whose ALT/AST > 1.5 times the upper limit of the normal range), or renal anomalies (serum creatinine > 1.5 times the upper limit of the normal value).
- Patients with a history of clinically significant Corrected QT Interval (QTc) prolongation (male > 450 ms; female > 470 ms), ventricular heart tachycardia and atrial fibrillation, II-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment.
- Surgery on the main organs within the past six weeks.
- Drug abuse or long-term alcohol abuse that would affect the evaluation results. Patients who have received organ transplants (excepting bone marrow transplantation).
- Patients not suitable for the study according to the investigator's assessment.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
About this study
Official title: Maintenance Therapy of Hypomethylating Agent (HMA) in Favorable Risk Acute Myeloid Leukemia (AML) Patients: A Single Arm, Multi Center Clinical Trial
HMA maintenance therapy is expected to benefit overall survival (OS) and relapse free survival (RFS) in AML patients with favorable risk.
Read the detailed description
Applying hypomethylating agents, azacitidine or decitabine as maintenance therapy in favorable-risk AML may prolong the remission duration and further improve their long-term survival.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Hypomethylating agent, Azacitidine or Decitabine
- Keywords
- AML, favorable risk, azacitidine, decitabine, maintenance therapy
- 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.
Hypomethylating agent, Azacitidine or DecitabineDrug
Also called Hypomethylating agent (HMA)
All enrolled patients received maintenance therapy consisting of Azacitidine (75mg/m2, subcutaneous injection, days 1-7) or Decitabine (20mg/m2, intravenous infusion, days 1-5), every three months as a cycle, for a maintenance therapy of 4-8 cycles.
| Study group | Role | What they receive |
|---|---|---|
| HMA maintenance therapy | Experimental | All enrolled patients received maintenance therapy consisting of azacitidine or decitabine. Receives: Drug: Hypomethylating agent, Azacitidine or Decitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse free survival (RFS)
It is measured from the date of entry into this trial to the date of hematologic relapse or death from any cause; subjects not known to have any of these events are censored on the date they were last examined.
Measured: 5 year
Secondary outcomes (2)
Overall survival (OS)
It is measured from the date of entry into this trial to the date of death from any cause; subjects not known to have died at last follow-up are censored on the date they were last known to be alive.
Measured: 5 year
Cumulative incidence of relapse (CIR)
CIR defined as from the time of recruitment to the study until the date of hematologic relapse.
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start1 Jul 2019
- Primary completion31 Jul 2026
- 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 Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Apply hypomethylating agent, azacitidine or decitabine as maintenance therapy.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Canglang Hospital of Suzhou, The Second People's Hospital of Huai'an, Suzhou Hospital of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Sheng-Li Xue, MD, The First Affiliated Hospital of Soochow University
- Investigators
- Sheng-Li Xue, M.D., Principal investigator, The First Affliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379360
- Sponsor's protocol ID
- SZAMLLRM01
- Status last verified
- Mar 2026
- First submitted
- 18 Apr 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance Therapy of Hypomethylating Agent (HMA) in Favorable Risk Acute Myeloid Leukemia (AML) Patients: A Single Arm, Multi Center Clinical Trial
- ClinicalTrials.gov ID
- NCT06379360
- Acronym / sponsor ID
- SZAMLLRM01
- Conditions
- Acute Myeloid Leukemia
- Keywords
- AML, favorable risk, azacitidine, decitabine, maintenance therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- Canglang Hospital of Suzhou, The Second People's Hospital of Huai'an, Suzhou Hospital of Traditional Chinese Medicine
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Apr 2024 (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.
HMA maintenance therapy is expected to benefit overall survival (OS) and relapse free survival (RFS) in AML patients with favorable risk.
Detailed description
Applying hypomethylating agents, azacitidine or decitabine as maintenance therapy in favorable-risk AML may prolong the remission duration and further improve their long-term survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Apply hypomethylating agent, azacitidine or decitabine as maintenance therapy.
| Arm | Type | Receives |
|---|---|---|
| HMA maintenance therapy | Experimental | Drug: Hypomethylating agent, Azacitidine or DecitabineAll enrolled patients received maintenance therapy consisting of azacitidine or decitabine. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patients aged ≥16 years;
- Patients diagnosed with AML and categorized into favorable-risk group according to European LeukemiaNet (ELN) 2017;
- Patients achieved remission after induction therapy and completed at least 3 cycles of high-dose cytarabine-based consolidation therapy, remaining in FCM-MRD-negative remission at enrollment. FCM-MRD was assessed by multiparameter flow cytometry, in accordance with expert consensus from China, with MRD positivity defined as ≥0.1%.
- Patients not receiving hematopoietic stem cell transplantation prior to enrollment;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
Key exclusion criteria (12 listed)
- Patients experienced hematologic relapse before recruitment.
- Patients who are allergic to the study drug or drugs with similar chemical structures.
- Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception.
- Active infection.
- Active bleeding.
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 |
|---|---|---|
| Hypomethylating agent, Azacitidine or DecitabineAlso: Hypomethylating agent (HMA)All enrolled patients received maintenance therapy consisting of Azacitidine (75mg/m2, subcutaneous injection, days 1-7) or Decitabine (20mg/m2, intravenous infusion, days 1-5), every three months as a cycle, for a maintenance therapy of 4-8 cycles. | Drug | HMA maintenance therapy |
Primary outcome
Relapse free survival (RFS)
Time frame: 5 year
It is measured from the date of entry into this trial to the date of hematologic relapse or death from any cause; subjects not known to have any of these events are censored on the date they were last examined.
2 secondary outcomes
Overall survival (OS)
Time frame: 5 year
Cumulative incidence of relapse (CIR)
Time frame: 5 year
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 21 Sep 2026.
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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.
Sheng-Li Xue, M.D. principal investigator
The First Affliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hypomethylating agent, Azacitidine or Decitabine in people with Acute Myeloid Leukemia, run by The First Affiliated Hospital of Soochow University 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 12 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 21 Sep 2026. 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 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?
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 (RFS) (time frame: 5 year). 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 21 Sep 2026.