Combining venetoclax and azacitidine for newly diagnosed T-ALL patients

A Prospective, Multi-Center Study to Evaluate the Efficacy and Safety of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-cell Acute Lymphoblastic Leukemia Patients

This study is testing a new treatment combining venetoclax and azacitidine to see if it helps people aged 15 and older who are newly diagnosed with T-cell acute lymphoblastic leukemia feel better.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Ages: 15 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT05376111 on ClinicalTrials.gov

What this trial studies

This phase 2, open-label, single-arm, multi-center study aims to evaluate the efficacy and safety of a treatment regimen combining venetoclax and azacitidine in patients newly diagnosed with T-cell acute lymphoblastic leukemia (T-ALL). Participants aged 15 and older will receive the combined therapy as an induction regimen. The study will assess how well this combination works in treating T-ALL and monitor any potential side effects. The research is being conducted at multiple sites, including The First Affiliated Hospital of Soochow University.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 15 and older who have been newly diagnosed with T-ALL.

Not a fit: Patients with serious underlying health conditions or those who cannot provide informed consent may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with newly diagnosed T-ALL.

How similar studies have performed: Other studies have shown promising results with similar combinations of therapies in treating various types of leukemia, suggesting potential for success in this approach.

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.

Where this trial is running

Suzhou, Jiangsu

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

Conditions: T-cell Acute Lymphoblastic Leukemia, Recruiting, Venetoclax, Azacitidine, T-ALL, Newly diagnosed