Venetoclax Combined With Azactidine in the Treatment of ALAL

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age15+
SponsorSheng-Li Xue, MD

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

23 Participants
are divided into 1 treatment group

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