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

Phase 2

Recruiting

• Conditions: Recruiting; T-cell Acute Lymphoblastic Leukemia
• Interventions: Drug: Venetoclax, Azacitidine

• Registration Number: NCT05376111
• Lead Sponsor: The First Affiliated Hospital of Soochow University

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.

Detailed 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.

Study Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2022-05-11
• Study First Submitted QC: 2022-05-11
• Study First Posted: 2022-05-17
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-22
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Venetclax combined with Azacitidine	Venetoclax, Azacitidine	T-cell acute lymphoblastic leukemia patients reveive venetoclax combined with azacitidine regimen treatment.

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	At the end of Cycle 1 (each cycle is 21 days)	The overall response (complete remission, complete remission with incomplete blood count recovery) rate achieved after one or two courses (21 days) induction therapy by venetoclax combined azacitidine regimen.

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	2 years	It is measured from the date of entry into this trial to the date of progression or death.
Overall survial (OS)	2 years	It is measured from the date of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.
Number of adverse events	2 years	Adverse events are evaluated with CTCAE V5.0.

Trial Locations

Locations (1)

The First Affliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China