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OncoMatch/Clinical Trials/NCT05376111

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

Is NCT05376111 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Venetoclax, Azacitidine for t-cell acute lymphoblastic leukemia.

Phase 2RecruitingThe First Affiliated Hospital of Soochow UniversityNCT05376111Data as of May 2026

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

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Extracted eligibility criteria

Cancer type

Acute Lymphoblastic Leukemia

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: chemotherapy

Patients who have received chemotherapy treatments related to the disease.

Lab requirements

Kidney function

serum creatinine > 1.5x ULN

Liver function

total bilirubin > 1.5x ULN, ALT/AST > 2.5x ULN or > 1.5x ULN with liver involvement

Cardiac function

No history of clinically significant QTc interval prolongation (male > 450 ms; female > 470 ms), ventricular tachycardia, atrial fibrillation, II-degree heart block, myocardial infarction within one year, congestive heart failure, or symptomatic coronary heart disease requiring drug treatment

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). 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.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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