NCT05901974 Venetoclax Combined With Azactidine in the Treatment of ALAL
| NCT ID | NCT05901974 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sheng-Li Xue, MD |
| Condition | Acute Leukemia of Ambiguous Lineage |
| Study Type | INTERVENTIONAL |
| Enrollment | 23 participants |
| Start Date | 2023-07-01 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 23 participants in total. It began in 2023-07-01 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Patients aged ≥ 15 years. 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: 1. Patients who are allergic to the study drug or drugs with similar chemical structures. 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05901974 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, studying Acute Leukemia of Ambiguous Lineage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05901974 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05901974 currently recruiting?
Yes, NCT05901974 is actively recruiting participants. Contact the research team at slxue@suda.edu.cn for enrollment information.
Where is the NCT05901974 trial being conducted?
This trial is being conducted at Suzhou, China.
Who is sponsoring the NCT05901974 clinical trial?
NCT05901974 is sponsored by Sheng-Li Xue, MD. The trial plans to enroll 23 participants.
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