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NCT Number: NCT05901974

Venetoclax Combined With Azactidine in the Treatment of ALAL

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.

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Key information

Conditions

Acute Leukemia of Ambiguous Lineage Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Biphenotypic, Acute Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affliated Hospital of Soochow University

Suzhou, China

Location status: Recruiting

Location contact

Sheng-Li Xue

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment.
  • Patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met.
  • Liver function abnormalities (total bilirubin > 1.5 times the upper limit of the normal range, ALT/AST > 2.5 times the upper limit of the normal range or patients with liver involvement whose ALT/AST > 1.5 times the upper limit of the normal range), or renal anomalies (serum creatinine > 1.5 times the upper limit of the normal value).
  • Patients with a history of clinically significant QTc interval prolongation (male > 450 ms; female > 470 ms), ventricular heart tachycardia and atrial fibrillation, II-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment.
  • Surgery on the main organs within the past six weeks.
  • Drug abuse or long-term alcohol abuse that would affect the evaluation results.
  • Patients who have received organ transplants (excepting bone marrow transplantation).
  • Patients not suitable for the study according to the investigator's assessment.

Treatment and study plan

Venetoclax

Drug

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

azactidine

Drug

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

Primary outcomes

  1. Overall Response Rate (ORR)

    Time frame: At the end of Cycle 1 (each cycle is 28 days)

    The overall response (complete remission, complete remission with incomplete blood count recovery) rate achieved after one or two courses (28 days) induction therapy by venetoclax combined azacitidine regimen.

  2. Complete Remission Rate (CRR)

    Time frame: At the end of Cycle 1 (each cycle is 28 days)

    The complete remission rate achieved after one or two courses (28 days) induction therapy by venetoclax combined azacitidine regimen.

Secondary outcomes

  1. Overall survival (OS)

    Time frame: 1 year

    It is measured from the date of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.

  2. Progression-Free Survival (PFS)

    Time frame: 1 year

    It is measured from the date of entry into this trial to the date of progression or death.

  3. Adverse events in hematological system

    Time frame: 1 year

    Record of adverse events in hematological system during and after designed venetoclax combined azacitidine regimen induction.

  4. Adverse events in other organs or systems

    Time frame: 1 year

    Record of adverse events in other organs or systems during and after designed venetoclax combined azacitidine regimen induction.

Study contacts

Contact information is provided by the study sponsor or research team.

Sheng-Li Xue, MD

CONTACT

[email protected]

0086-0512-67781139

Sponsors and collaborators

Lead sponsor

Sheng-Li Xue, MD

Other

Collaborators

  • Affiliated Hospital of Nantong University
  • Canglang Hospital of Suzhou
  • Jining Medical University
  • Northern Jiangsu People's Hospital
  • Pingdingshan first people's Hospital
  • Second Affiliated Hospital of Wannan Medical College
  • Suzhou Hospital of Traditional Chinese Medicine
  • The First Affiliated Hospital of Bengbu Medical University
  • The Second People's Hospital of Huai'an

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 13, 2023
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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