Using hypomethylating agents to maintain remission in favorable risk AML patients

Maintenance Therapy of Hypomethylating Agent (HMA) in Favorable Risk Acute Myeloid Leukemia (AML) Patients: A Single Arm, Multi Center Clinical Trial

This study is testing if using hypomethylating agents like azacitidine and decitabine can help people with favorable-risk acute myeloid leukemia stay in remission longer and live better lives.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 77 (estimated)
• Ages: 16 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (Academic / other)
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT06379360 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of hypomethylating agents, specifically azacitidine and decitabine, as maintenance therapy for patients with favorable-risk acute myeloid leukemia (AML). The goal is to prolong remission duration and improve long-term survival outcomes in these patients. Eligible participants must have achieved remission after induction therapy and completed at least three cycles of high-dose consolidation therapy while remaining in minimal residual disease negative status. The study aims to assess the overall survival and relapse-free survival rates among participants receiving this treatment.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 16 years and older who have favorable-risk AML and are in remission after initial treatment.

Not a fit: Patients who have experienced hematologic relapse or those with serious comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance survival rates and quality of life for patients with favorable-risk AML.

How similar studies have performed: While the use of hypomethylating agents has shown promise in other studies, this specific application as maintenance therapy in favorable-risk AML is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Patients aged ≥16 years;
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:

1. Patients experienced hematologic relapse before recruitment.
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.

Where this trial is running

Suzhou, Jiangsu

• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)

Study contacts

• Principal investigator: Sheng-Li Xue, M.D. — The First Affliated Hospital of Soochow University
• Study coordinator: Sheng-Li Xue, M.D.

Conditions Acute Myeloid Leukemia; AML; favorable risk; azacitidine; decitabine; maintenance therapy