RecruitingPhase 2

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

China28 participantsStarted 2022-04-01

Plain-language 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.

Age range15 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Overall Response Rate (ORR)

Timeframe: At the end of Cycle 1 (each cycle is 21 days)

NCT IDNCT05376111

SponsorThe First Affiliated Hospital of Soochow University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-01

Who can participate

Age range15 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.