Venetoclax Combined With Azactidine in the Treatment of ALAL
Condition(s) studied
Investigational drug(s) / intervention(s)
Venetoclax: Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-28);
azactidine: azacitidine 75 mg/m2 subcutaneously once daily on days 1-7
Study 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.
Eligibility
Primary outcome measure(s)
- Overall Response Rate (ORR) — At the end of Cycle 1 (each cycle is 28 days)
The overall response (complete remission, complete remission with incomplete blood count recovery) rate achieved after one or two courses (28 days) induction therapy by venetoclax combined azacitidine regimen. - Complete Remission Rate (CRR) — At the end of Cycle 1 (each cycle is 28 days)
The complete remission rate achieved after one or two courses (28 days) induction therapy by venetoclax combined azacitidine regimen.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| The First Affliated Hospital of Soochow University | Suzhou | China | Recruiting |
On this site
📄 Venclexta (venetoclax) drug profile →More Sheng-Li Xue, MD trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05901974 on ClinicalTrials.gov ↗ ← All trials in China