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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 15
Healthy Volunteers: f
View:

• 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.

• Expected survival time ≥3 months.

• Patients without serious heart, lung, liver, or kidney disease.

• Ability to understand and voluntarily provide informed consent.

Locations
Other Locations
China
The First Affliated Hospital of Soochow University
RECRUITING
Suzhou
Contact Information
Primary
Sheng-Li Xue, MD
slxue@suda.edu.cn
0086-0512-67781139
Time Frame
Start Date: 2023-07-01
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 23
Treatments
Experimental: Venetoclax Combined With azactidine in the Treatment of Acute Leukaemias of Ambiguous Lineage
Venetoclax combined with azacitidine regimen. Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-28); azacitidine 75 mg/m2 subcutaneously once daily on days 1-7 .
Related Therapeutic Areas
Sponsors
Collaborators: Northern Jiangsu People's Hospital, Affiliated Hospital of Nantong University, The First Affiliated Hospital of Bengbu Medical University, Jining Medical University, Suzhou Hospital of Traditional Chinese Medicine, The Second People's Hospital of Huai'an
Leads: Sheng-Li Xue, MD

This content was sourced from clinicaltrials.gov