About this trial
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 criteria
Qualifiers
Patients aged ≥ 15 years.
Patients diagnosed with ALAL according to 5th edition of WHO Acute Leukaemias of Ambiguous Lineage diagnosis standard.
New diagnosed patients.
ECOG performance status score less than 3.
Disqualifiers
Patients who are allergic to the study drug or drugs with similar chemical structures.
Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception.
Active infection.
Active bleeding.
Trial design
Treatments tested in this trial
- Venetoclax
- azactidine
Treatment groups
Sponsors and collaborators
Sheng-Li Xue, MD
Lead sponsor
The First Affiliated Hospital of Soochow University
Sponsor institution
Jining Medical University
Collaborator
The Second People's Hospital of Huai'an
Collaborator
The First Affiliated Hospital of Bengbu Medical University
Collaborator
Affiliated Hospital of Nantong University
Collaborator
Suzhou Hospital of Traditional Chinese Medicine
Collaborator
Northern Jiangsu People's Hospital
Collaborator
Pingdingshan first people's Hospital
Collaborator
The Second Affiliated Hospital of Wannan Medical College
Collaborator
Canglang Hospital of Suzhou
Collaborator