Clinical Study Protocol of Maintenance Therapy With Venetoclax in Elderly Patients With AM
This clinical study evaluates the efficacy and safety of maintenance therapy with BCL-2 inhibitors in elderly patients with acute myeloid leukemia (AML) in first complete remission. This study involves the following content: BCL-2 inhibitors.
| Condition(s) | Acute Myeloid Leukemia |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | This clinical study evaluates the efficacy and safety of maintenance therapy with BCL-2 inhibitors in elderly patients with acute myeloid leukemia (AML) in first complete remission. This study involves the following content: BCL-2 inhibitors. |
| Who can participate | Inclusion Criteria: * Patients with acute myeloid leukemia (AML) diagnosed based on bone marrow morphology and immunophenotyping (meeting the diagnostic criteria of WHO 2016). * Achieving first complete remission (CR) or incomplete complete remission (CRi) after 1-2 cycles of induction therapy and receiving consolidation treatment for at least 4 cycles. * Age between 60 and 85 years. * Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 3 times the upper limit of normal (ULN), serum bilirubin ≤ 1.5 times ULN, serum creatinine ≤ 2.0 times ULN, and serum creatine kinase \< 2.0 times ULN. * Left ventricular ejection fraction (LVEF) ≥ 50% as determined by echocardiography. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3 |
| Ages | 60 Years to 85 Years |
| Sex | All |
| Lead sponsor | The First Affiliated Hospital with Nanjing Medical University |
| Locations | Nanjing, Jiangsu, China |
| Start date | 2023-04-12 |
| NCT ID | NCT05909293 |
| Official listing | https://clinicaltrials.gov/study/NCT05909293 |