NCT05901974RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 16 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 23 (estimated)
- First submitted
- 4 Jun 2023
- Start date
- 1 Jul 2023
- Primary completion date
- 1 Mar 2026
- Lead sponsor
- Sheng-Li Xue, MD
- Diseases
- Childhood cancers
- NCT number
- NCT05901974
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 23
- From 1 Jul 2023 to the primary completion date, 1 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior 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).
Other illness
- Patients who are allergic to the study drug or drugs with similar chemical structures.
- 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.
Lab values
- 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.
Age
- Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception.
Other
- Patients not suitable for the study according to the investigator's assessment.
Who the study is looking for
- 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.
Age in the registry: 15 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.