NCT05264883

Venetoclax+HMA+Aclarubicin Versus Venetoclax+HMA in Treatment-Naive Elderly Patients With AML

Comparing the Efficacy and Safety of Venetoclax Combined With Decitabine/Azacitidine and Aclarubicin Versus Venetoclax Combined With Decitabine/Azacitidine in Treatment-Naive Elderly Patients With Acute Myeloid Leukemia

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Not accepted

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)

Detailed description

This is an open-label, multicenter, phase Ⅲ randomized clinical trial to compare the therapeutic efficacy and safety of Venetoclax combined with Decitabine/Azacitidine and Aclarubicin versus Venetoclax combined with Decitabine/Azacitidine in treatment-naive elderly patients with Acute Myeloid Leukemia (AML). The FDA has approved the combination therapy of Venetoclax and Decitabine/Azacitidine for elderly (\> 60-year-old) patients with newly diagnosed AML not eligible for intensive chemotherapy. Venetoclax is an inhibitor of BCL-2 (B-cell lymphoma 2, a protein that initiates tumor growth, disease progression, and drug resistance), which can lead to cancer cell death. Aclarubicin (Acla) is an anthracycline antitumor drug and is a type II topoisomerase Inhibitor that prevents topoisomerase II from binding to DNA primarily by intercalating into DNA strands, resulting in chromatin damage injury without causing DNA damage. In addition to causing chromatin damage, Acla also results in epigenetic inheritance Changes in gene transmission, DNA damage response signals, and apoptosis. Furthermore, in the cytoplasm, Acla can also exert cytotoxic effects by affecting mitochondrial respiratory function. Therefore, Acla is a highly efficient and broad-spectrum chemotherapeutic drug, which is widely used in the treatment of various hematological tumors and solid tumors. In treatment-naive elderly patients with AML, the DCAG (Decitabine-Cytarabine-Aclarubicin-GCSF) regimen can improve the prognosis according to our previous research results. Acla also has relatively mild side effects in the treatment of AML patients. Participants will be randomly assigned to one of the different treatment groups and followed with consolidated therapy with the same regimen of 2-4 cycles. After completion of study treatment, participants are followed up every 3 months for up to 2 years. It is expected that about 170 people will take part in this research study.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Venetoclax-Decitabine/Azacitidine-Aclarubicin Association	Treatment with Venetoclax+Decitabine/Azacitidine+Aclarubicin
DRUG	Venetoclax-Decitabine/Azacitidine Association	Treatment with Venetoclax+Decitabine/Azacitidine

Timeline

• Start date: 2021-03-01
• Primary completion: 2023-06-28
• Completion: 2025-02-28
• First posted: 2022-03-03
• Last updated: 2023-05-30

Locations

1 site across 1 country: China