Maintenance Therapy of Hypomethylating Agent (HMA) in Favorable Risk Acute Myeloid Leukemi
HMA maintenance therapy is expected to benefit overall survival (OS) and relapse free survival (RFS) in AML patients with favorable risk.
| Condition(s) | Acute Myeloid Leukemia |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | HMA maintenance therapy is expected to benefit overall survival (OS) and relapse free survival (RFS) in AML patients with favorable risk. |
| Who can participate | 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 th |
| Ages | 16 Years |
| Sex | All |
| Lead sponsor | The First Affiliated Hospital of Soochow University |
| Locations | Suzhou, Jiangsu, China |
| Start date | 2020-11-01 |
| NCT ID | NCT06379360 |
| Official listing | https://clinicaltrials.gov/study/NCT06379360 |