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

T-cell Acute Lymphoblastic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05376111
• Other study ID #: SZTALL01
• Status: Recruiting
• Phase: Phase 2
• Start date: April 1, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: July 2023
• Source: The First Affiliated Hospital of Soochow University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
• Recruiting
• T-cell Acute Lymphoblastic Leukemia

Intervention

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.

Locations

Country	Name	City	State
China	The First Affliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (7)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University	Affiliated Hospital of Nantong University, First Affiliated Hospital Bengbu Medical College, Jining Medical University, Northern Jiangsu Province People's Hospital, Suzhou Hospital of Traditional Chinese Medicine, The Second People's Hospital of Huai'an

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR)	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.	At the end of Cycle 1 (each cycle is 21 days)
Secondary	Overall survial (OS)	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.	2 years
Secondary	Progression-Free Survival (PFS)	It is measured from the date of entry into this trial to the date of progression or death.	2 years
Secondary	Number of adverse events	Adverse events are evaluated with CTCAE V5.0.	2 years