Venetoclax Based Regimen for R/R T-ALL

Korábbi kezelés

• 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 organ transplants (excepting bone marrow transplantation).

Más betegség

• Patients who are allergic to the study drug or drugs with similar chemical structures.
• Active infection.
• 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.

Laborértékek

• Liver function abnormalities (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.

Életkor

• Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception.

Egyéb

• Patients not suitable for the study according to the investigator's assessment.

• Patients aged ≥ 15 and ≤ 70 years.
• Patients diagnosed with T-ALL/LBL according to 2017 WHO lymphoid malignant disease diagnosis standard.
• Patients with T-ALL/LBL must meet one of the following criteria, A or B.
  • A: Refractory T-ALL/LBL disease was defined as follows: Failure to achieve CR at the end of induction.
  • B: Relapsed T-ALL/LBL disease was defined as follows: Reappearance of blasts in the blood or bone marrow (>5%) or in any extramedullary site after a CR.
• ECOG performance status score less than 3.
• Expected survival time >3 months.
• Patients without serious heart, lung, liver, or kidney disease.
• Ability to understand and voluntarily provide informed consent.