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

Soochow University

Status and phase: Enrolling; Phase 2

Conditions: T-cell Acute Lymphoblastic Leukemia; Recruiting

Treatments: Drug: Venetoclax, Azacitidine

Study type: Interventional

Funder types: Other

Identifiers

NCT05376111

SZTALL01

Details and patient eligibility

About

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

Full description

This is a phase 2, open Label, single arm, multi-center study for newly diagnosed T-cell acute lymphoblastic leukemia patients. The patients will receive vanetoclax combined with azacitidine as the induction regimen.

Enrollment: 28 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Venetclax combined with Azacitidine

Experimental group

Description:

T-cell acute lymphoblastic leukemia patients reveive venetoclax combined with azacitidine regimen treatment.

Treatment:

Drug: Venetoclax, Azacitidine