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Recruiting NCT05376111

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

Phase II Interventional T-cell Acute Lymphoblastic Leukemia Recruiting

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Venetoclax, Azacitidine.
Who it may be relevant to
Registry conditions: T-cell Acute Lymphoblastic Leukemia, Recruiting. Basic parameters: from 15 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Overall Response Rate (ORR) [Time frame: At the end of Cycle 1 (each cycle is 21 days)]
Secondary outcome measures (3)
  • Overall survial (OS) [Time frame: 2 years]
  • Progression-Free Survival (PFS) [Time frame: 2 years]
  • Number of adverse events [Time frame: 2 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affliated Hospital of Soochow University — Suzhou

Identifiers

NCT: NCT05376111 · SZTALL01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗