Venetoclax Combined With Azactidine in the Treatment of ALAL

Launched by SHENG-LI XUE, MD · Jun 4, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients diagnosed with Acute Leukemia of Ambiguous Lineage (ALAL), a type of blood cancer that is often difficult to treat. The researchers want to see if combining two medications, venetoclax and azacitidine, can help improve treatment outcomes for patients who are newly diagnosed with this condition. Venetoclax has already shown promise in treating other types of leukemia, and this trial aims to find out if it can be effective for ALAL as well.

To participate in the trial, patients need to be between 15 and 65 years old, have a confirmed diagnosis of ALAL, and meet certain health criteria. For example, they should not have serious heart or liver problems and should be able to give informed consent. Those who join the study can expect to receive the new treatment and be closely monitored for its effects. This research is important because there are currently limited options available for treating ALAL, and the results could lead to better therapies in the future.

Gender

ALL

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.