Maintenance Therapy of Hypomethylating Agent (HMA) in Favorable Risk Acute Myeloid Leukemia (AML) Patients
NCT ID: NCT06379360
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
77 participants
INTERVENTIONAL
2020-11-01
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HMA maintenance therapy
All enrolled patients received maintenance therapy consisting of azacitidine or decitabine.
Hypomethylating agent, Azacitidine or Decitabine
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.
Interventions
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Hypomethylating agent, Azacitidine or Decitabine
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients diagnosed with AML and categorized into favorable-risk group according to European LeukemiaNet (ELN) 2022;
3. Patients achieved remission after induction therapy and finished at least 3 cycles of high-dose Aar-C based consolidation therapy, remaining in minimal residual disease (MRD) negative remission status (For NPM1-mutated and core binding factor acute myeloid leukemia (CBF-AML), MRD negative is defined as \<2%, CEBPA-mutated AML, MRD negative is defined as \<0.1%).
4. Patients not receiving hematopoietic stem cell transplantation prior to enrollment;
5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
6. Expected survival time ≥ 3 months;
7. No serious heart, lung, liver or kidney disease;
8. Have the ability to understand and be willing to sign the informed consent form for this trial.
Exclusion Criteria
2. Patients who are allergic to the study drug or drugs with similar chemical structures.
3. Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception.
4. Active infection.
5. Active bleeding.
6. Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment.
7. 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.
8. 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).
9. 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.
10. Surgery on the main organs within the past six weeks.
11. Drug abuse or long-term alcohol abuse that would affect the evaluation results. Patients who have received organ transplants (excepting bone marrow transplantation).
12. Patients not suitable for the study according to the investigator's assessment.
16 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Soochow University
OTHER
Responsible Party
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Sheng-Li Xue, MD
Principal Investigator
Principal Investigators
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Sheng-Li Xue, M.D.
Role: PRINCIPAL_INVESTIGATOR
The First Affliated Hospital of Soochow University
Locations
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The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Sheng-Li Xue, M.D.
Role: primary
Other Identifiers
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SZAMLLRM01
Identifier Type: -
Identifier Source: org_study_id