drugset / Trial / NCT05053425
Bcl-2 Inhibitors Combined With Azacytidine and Chemotherapy in Elderly Patients With Previously Untreated AML
NaSingle-groupOpen-labelTreatment
Summary
In this prospective study, 30 newly untreated elderly patients with acute myeloid leukemia(AML) who were not suitable for standard chemotherapy were enrolled to observe the efficacy and side effects of venetoclax (VEN) combined with azacytidine (AZA) and chemotherapy in newly treated elderly patients with AML. Overall survival (OS), complete remission rate/complete remission with incomplete recovery of blood cell count (CR/ CRi) were used as the primary endpoints, and time to response (TTR), duration of response (DOR), mortality, and recurrence rate were used as secondary endpoints,and the incidence of adverse events were evaluated.
Timeline
- Start
- 2021-10-20
- Primary completion
- 2023-01-18
- Completion
- 2023-03-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 75 mg/m2 | Subcutaneous |
| Subject | Cladribine | Small molecule | 5 mg/m2 | Intravenous |
| Subject | Cytarabine | Small molecule | 10 mg/m2 | Subcutaneous |
| Subject | Cytarabine | Small molecule | 100 mg/m2 | Subcutaneous |
| Subject | Cytarabine | Small molecule | 0.5 g/kg | Subcutaneous |
| Subject | Cytarabine | Small molecule | 1 g/kg | Subcutaneous |
| Subject | Idarubicin | Small molecule | 8 mg/m2 | Intravenous |
| Subject | Venetoclax | Small molecule | 400 mg | Oral |