drugset / Trial / NCT05264883
Venetoclax+HMA+Aclarubicin Versus Venetoclax+HMA in Treatment-Naive Elderly Patients With AML
Phase 3
Unknown
170 enrolled
The First Affiliated Hospital with Nanjing Medical University
Huai'an First People's Hospital · collabThe Affiliated Jiangning Hospital of Nanjing Medical University · collabYancheng First People's Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This research is being done to assess the therapeutic efficacy and safety of a promising regimen (Venetoclax combined with Decitabine/Azacitidine and Aclarubicin) versus Venetoclax combined with Decitabine/Azacitidine in treatment-naive elderly patients with Acute Myeloid Leukemia. This study involves the following: Venetoclax, Decitabine/Azacitidine, Aclarubicin (investigational combination) Venetoclax and Decitabine/Azacitidine (per standard of care)
Timeline
- Start
- 2021-03-01
- Primary completion
- 2023-06-28
- Completion
- 2025-02-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aclarubicin | Small molecule | 10 mg/m2 | Intravenous |
| Comparator | Azacitidine | Other / unclassified | 75 mg/m2 | Subcutaneous |
| Comparator | Decitabine | Small molecule | 20 mg/m2 | Intravenous |
| Comparator | Venetoclax | Small molecule | 400 mg | Oral |