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Venetoclax Combined With Azactidine in the Treatment of ALAL

NCT05901974 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-12-16

No results posted yet for this study

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.

Conditions

  • Acute Leukemia of Ambiguous Lineage

Interventions

DRUG

Venetoclax

Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-28);

DRUG

azactidine

azacitidine 75 mg/m2 subcutaneously once daily on days 1-7

Sponsors & Collaborators

  • Jining Medical University

    collaborator OTHER

  • The Second People's Hospital of Huai'an

    collaborator OTHER

  • The First Affiliated Hospital of Bengbu Medical University

    collaborator OTHER

  • Affiliated Hospital of Nantong University

    collaborator OTHER

  • Suzhou Hospital of Traditional Chinese Medicine

    collaborator OTHER

  • Northern Jiangsu People's Hospital

    collaborator OTHER

  • Pingdingshan first people's Hospital

    collaborator UNKNOWN

  • The Second Affiliated Hospital of Wannan Medical College

    collaborator UNKNOWN

  • Canglang Hospital of Suzhou

    collaborator UNKNOWN

  • Sheng-Li Xue, MD

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2026-03-01
Completion
2026-03-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05901974 on ClinicalTrials.gov