Study of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-ALL Patients

Launched by THE FIRST AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY · May 11, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a combination of two medications, venetoclax and azacitidine, to see how well they work together for patients who have recently been diagnosed with T-cell Acute Lymphoblastic Leukemia (T-ALL). The goal is to find out if this treatment is both effective and safe for these patients. The trial is currently looking for participants aged 15 and older who meet specific health criteria, such as not having serious heart or liver problems and being able to understand the study and give their consent.

If you or someone you know is considering joining this study, participants can expect to receive the study medications and be closely monitored by healthcare professionals throughout the trial. It's important to note that certain individuals, like those with specific allergies to the study drugs, pregnant or breastfeeding women, and those with ongoing infections or serious medical issues, may not be eligible to participate. This trial aims to provide valuable information that could help improve treatment options for T-ALL in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients aged ≥ 15.
• • 2. Patients diagnosed with T-ALL according to 2016 WHO criteria for precursor lymphoid neoplasms.
• • 3. ECOG performance status score less than 3.
• • 4. Patients without serious heart, lung, liver, or kidney dysfunction.
• • 5. 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. Patients with uncontrolled active infection
• • 4. Patients with 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 dysfunction (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 chemotherapy treatments related to the disease.