Status:
RECRUITING
Study of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-ALL Patients
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Collaborating Sponsors:
Jining Medical University
The Second People's Hospital of Huai'an
Conditions:
T-cell Acute Lymphoblastic Leukemia
Recruiting
Eligibility:
All Genders
15+ years
Phase:
PHASE2
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 in...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT05376111
Start Date
April 1 2022
End Date
December 1 2025
Last Update
December 27 2024
Active Locations (1)
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1
The First Affliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006