Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of R/R AML

Korábbi kezelés

• Suffered from other non-myeloid malignancies within 2 years, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease
• Previous solid organ transplantation (SCT treatment is allowed in advance, but if the patient has GVHD or is still receiving immunosuppression/GVHD treatment, it is not allowed)

Más betegség

• Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy;
• Mental disorders that hinder research participation

Laborértékek

• Uncontrolled or significant cardiovascular disease, including any of the following:
  • Bradycardia of less than 50 beats per minute, unless the subject has a pacemaker; Diagnosis of or suspicion of long QT syndrome (including family history of long QT syndrome);
  • Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg; History of clinically relevant ventricular arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes);
  • History of second (Mobitz II) or third degree heart block (subjects with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker);
  • History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to Screening;
  • History of New York Heart Association Class 3 or 4 heart failure;
  • Complete left bundle branch block;
  • Known history of left ventricular ejection fraction (LVEF) ≤45% or less than the institutional lower limit of normal;

Egyéb

• Diagnosis of acute promyelocytic leukemia (APL)
• Central nervous system leukemia
• Females who are pregnant or breastfeeding;
• Any other situation where the investigator believes that the patient should not participate in this trial

• Age ≥18
• Relapsed and refractory patients with acute myeloid leukemia via morphology and immunology
• ECOG：0-2
• Life expectancy ≥ 3 months
• Adequate laboratory parameters during the screening period as evidenced by the following:
  • Creatinine clearance≥30 mL/min and serum Creatinine ≤ 160µmol/L
  • ALT and AST ≤ 3 × upper limit of normal (ULN)
  • Able to understand and sign an informed consent form (ICF).