Combining Venetoclax and Azacitidine for treating Acute Leukemia of Ambiguous Lineage

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

This study is testing if combining two medications, venetoclax and azacitidine, can help people aged 15 to 65 who have just been diagnosed with Acute Leukemia of Ambiguous Lineage feel better and live longer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (estimated)
• Ages: 15 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Suzhou)
• Trial ID: NCT05901974 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of combining venetoclax with azacitidine in patients newly diagnosed with Acute Leukemia of Ambiguous Lineage (ALAL). The study aims to improve remission rates and overall survival for this patient population, which currently has a poor prognosis. Participants will be closely monitored for treatment response and any adverse effects. The trial is designed for patients aged 15 to 65 who meet specific health criteria.

Who should consider this trial

Good fit: Ideal candidates are patients aged 15 to 65 who have been newly diagnosed with ALAL and meet the study's health criteria.

Not a fit: Patients with serious underlying health conditions or those who are pregnant or lactating may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve remission rates and survival outcomes for patients with ALAL.

How similar studies have performed: While there are few studies specifically on ALAL, similar combinations of venetoclax with other agents have shown promising results in treating related conditions.

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.

Where this trial is running

Suzhou

• The First Affliated Hospital of Soochow University — Suzhou, China (Recruiting)

Study contacts

• Study coordinator: Sheng-Li Xue, MD

Conditions Acute Leukemia of Ambiguous Lineage