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Recruiting Phase 2 NCT05376111

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

Trial Parameters

Condition T-cell Acute Lymphoblastic Leukemia
Sponsor The First Affiliated Hospital of Soochow University
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 28
Sex ALL
Min Age 15 Years
Max Age N/A
Start Date 2022-04-01
Completion 2026-12-01
Interventions
Venetoclax, Azacitidine

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of venetoclax combined with azacitidine regimen for newly diagnosed T-ALL patients.

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

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