Venetoclax Combined With Azactidine in the Treatment of ALAL
NCT ID: NCT05901974
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
23 participants
INTERVENTIONAL
2023-07-01
2026-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Venetoclax Combined With azactidine in the Treatment of Acute Leukaemias of Ambiguous Lineage
Venetoclax combined with azacitidine regimen. Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-28); azacitidine 75 mg/m2 subcutaneously once daily on days 1-7 .
Venetoclax
Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-28);
azactidine
azacitidine 75 mg/m2 subcutaneously once daily on days 1-7
Interventions
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Venetoclax
Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-28);
azactidine
azacitidine 75 mg/m2 subcutaneously once daily on days 1-7
Eligibility Criteria
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Inclusion Criteria
2. Patients diagnosed with ALAL according to 5th edition of WHO Acute Leukaemias of Ambiguous Lineage diagnosis standard.
3. New diagnosed patients.
4. ECOG performance status score less than 3.
5. Expected survival time ≥3 months.
6. Patients without serious heart, lung, liver, or kidney disease.
7. Ability to understand and voluntarily provide informed consent.
Exclusion Criteria
2. Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception.
3. Active infection.
4. Active bleeding.
5. Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment.
6. 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.
7. 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).
8. 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.
9. Surgery on the main organs within the past six weeks.
10. Drug abuse or long-term alcohol abuse that would affect the evaluation results.
11. Patients who have received organ transplants (excepting bone marrow transplantation).
12. Patients not suitable for the study according to the investigator's assessment.
15 Years
ALL
No
Sponsors
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Jining Medical University
OTHER
The Second People's Hospital of Huai'an
OTHER
The First Affiliated Hospital of Bengbu Medical University
OTHER
Affiliated Hospital of Nantong University
OTHER
Suzhou Hospital of Traditional Chinese Medicine
OTHER
Northern Jiangsu People's Hospital
OTHER
Pingdingshan first people's Hospital
UNKNOWN
The Second Affiliated Hospital of Wannan Medical College
UNKNOWN
Canglang Hospital of Suzhou
UNKNOWN
Sheng-Li Xue, MD
OTHER
Responsible Party
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Sheng-Li Xue, MD
Professor
Locations
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The First Affliated Hospital of Soochow University
Suzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Sheng-Li Xue
Role: primary
Other Identifiers
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SZALAL01
Identifier Type: -
Identifier Source: org_study_id