RecruitingPhase 2NCT05901974

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

Sponsor

Sheng-Li Xue, MD

Enrollment

23 participants

Start Date

Jul 1, 2023

Study Type

INTERVENTIONAL

Conditions

Acute Leukemia of Ambiguous Lineage

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

Min Age: 15 Years

Plain Language Summary

Simplified for easier understanding

This study is testing venetoclax plus azacitidine — a combination of a targeted cancer drug and a chemotherapy drug — for people newly diagnosed with acute leukemia of ambiguous lineage (ALAL), a very rare blood cancer that shows features of more than one type of leukemia. **You may be eligible if...** - You are 15 or older - You have a new diagnosis of ALAL confirmed by the latest WHO criteria - Your general health is adequate (ECOG status below 3) - Your heart, lungs, liver, and kidneys are functioning adequately - Expected survival is at least 3 months **You may NOT be eligible if...** - You are allergic to the study drugs or chemically similar medications - You are pregnant, breastfeeding, or unwilling to use contraception - You have active infections or active bleeding - You have had a recent blood clot, stroke, or brain bleed in the past year - You have a mental disorder that prevents you from giving informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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