Actively Recruiting

Phase 2
Age: 15Years +
All Genders
NCT05901974

Venetoclax Combined With Azactidine in the Treatment of ALAL

Led by Sheng-Li Xue, MD · Updated on 2025-12-16

23

Participants Needed

1

Research Sites

139 weeks

Total Duration

On this page

Sponsors

S

Sheng-Li Xue, MD

Lead Sponsor

J

Jining Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Venetoclax Combined With Azactidine in the Treatment of ALAL

Who Can Participate

Age: 15Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 6 15 years.
  • Diagnosed with ALAL according to the 5th edition of WHO standards.
  • Newly diagnosed ALAL patients.
  • ECOG performance status score less than 3.
  • Expected survival time of at least 3 months.
  • No serious heart, lung, liver, or kidney disease.
  • Ability to understand and voluntarily provide informed consent.
Not Eligible

You will not qualify if you...

  • Allergy to the study drug or similar drugs.
  • Pregnant or breastfeeding women, or women of childbearing age not using effective contraception.
  • Active infection.
  • Active bleeding.
  • New thrombosis, embolism, cerebral hemorrhage, or related history within one year before enrollment.
  • Mental disorders or conditions preventing informed consent or study compliance.
  • Liver function abnormalities above specified limits or renal anomalies.
  • History of significant heart rhythm problems, heart attack within one year, congestive heart failure, or symptomatic coronary heart disease.
  • Surgery on main organs within the past six weeks.
  • Drug or long-term alcohol abuse affecting evaluation.
  • History of organ transplantation (except bone marrow).
  • Considered unsuitable by the investigator.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Affliated Hospital of Soochow University

Suzhou, China

Actively Recruiting

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Research Team

S

Sheng-Li Xue, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Venetoclax Combined With Azactidine in the Treatment of ALAL | DecenTrialz