NCT05901974

Venetoclax Combined With Azactidine in the Treatment of ALAL

A Multicenter Prospective Clinical Study of Venetoclax Combined With Azactidine in the Treatment of Acute Leukaemias of Ambiguous Lineage

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (estimated)
• Sponsor: Sheng-Li Xue, MD · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

The prognosis of acute leukaemias of ambiguous lineage is poor. The effect of chemotherapy regimen and hematopoietic stem cell transplantation are still unclear. Therefore, we will explore new therapy to improve the remission rate of acute leukaemias of ambiguous lineage. Venetoclax can significantly improve the remission rate and prolong PFS and OS. At present, venetoclax combined with azacitidine or decitabine has become the preferred treatment regimen for elderly AML patients. It also shows a high response rate in relapsed/refractory AML or MDS patients. There are few clinical studies on the treatment of ALAL. The purpose of this study is to explore the efficacy and safety of venetoclax combined with azacitidine in the treatment of newly diagnosed ALAL patients.

Conditions

• Acute Leukemia of Ambiguous Lineage

Interventions

Type	Name	Description
DRUG	Venetoclax	Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-28);
DRUG	azactidine	azacitidine 75 mg/m2 subcutaneously once daily on days 1-7

Timeline

• Start date: 2023-07-01
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2023-06-13
• Last updated: 2025-12-16

Locations

1 site across 1 country: China