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

Sponsor

The First Affiliated Hospital of Soochow University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05376111

Collaborator

Jining Medical University (Other), The Second People's Hospital of Huai'an (Other), First Affiliated Hospital Bengbu Medical College (Other), Northern Jiangsu Province People's Hospital (Other), Affiliated Hospital of Nantong University (Other), Suzhou Hospital of Traditional Chinese Medicine (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
T-cell Acute Lymphoblastic Leukemia Recruiting	Drug: Venetoclax, Azacitidine	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

28 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Venetclax combined with Azacitidine T-cell acute lymphoblastic leukemia patients reveive venetoclax combined with azacitidine regimen treatment.	Drug: Venetoclax, Azacitidine Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-21); azacitidine 75 mg/m2 subcutaneously once daily on days 1-7.

Arm

Intervention/Treatment

Experimental: Venetclax combined with Azacitidine

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

Drug: Venetoclax, Azacitidine

Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-21); azacitidine 75 mg/m2 subcutaneously once daily on days 1-7.

Outcome Measures

Primary Outcome Measures

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

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.
Progression-Free Survival (PFS) [2 years]
It is measured from the date of entry into this trial to the date of progression or death.
Number of adverse events [2 years]
Adverse events are evaluated with CTCAE V5.0.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients aged ≥ 15.
Patients diagnosed with T-ALL according to 2016 WHO criteria for precursor lymphoid neoplasms.
ECOG performance status score less than 3.
Patients without serious heart, lung, liver, or kidney dysfunction.
Ability to understand and voluntarily provide informed consent.

Exclusion Criteria:

Patients who are allergic to the study drug or drugs with similar chemical structures.
Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception.
Patients with uncontrolled active infection
Patients with active bleeding.
Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment.
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.
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.
Surgery on the main organs within the past six weeks.
Drug abuse or long-term alcohol abuse that would affect the evaluation results.
Patients who have received chemotherapy treatments related to the disease.