Chiglitazar Sodium Combined With Venetoclax and Azacitidine (CVA) for the Treatment of R/R AML

Prior treatment

• Previous solid organ transplantation (pre-treatment with SCT is allowed, but not allowed if the patient has GVHD or is still receiving immunosuppressive/GVHD treatment);

Other illness

• Active, uncontrolled severe infection;
• Other non-myeloid malignancies within the past 2 years;
• Mental disorders that would impede study participation;
• Any other conditions that, in the opinion of the investigator, make the patient unsuitable to participate in this trial.

Lab values

• Patients with clinically significant QTc interval prolongation (males \> 450 ms; females \> 470 ms), ventricular tachycardia and atrial fibrillation, second-degree heart block, history of myocardial infarction and congestive heart failure within the year prior to enrollment, and patients with clinically symptomatic coronary heart disease requiring medication;

Other

• Acute promyelocytic leukemia (APL);
• Active central nervous system leukemia;

• Acute myeloid leukemia (AML) confirmed by histology. Relapsed or refractory AML, including: a) Refractory disease is defined as no remission after at least one prior treatment. b) Disease relapse is defined as 5% or more blasts in the bone marrow after remission. c) Patients with AML arising from myelodysplastic syndromes (including CMML) or myeloproliferative neoplasms (secondary AML, t-AML) are also eligible;
• Age ≥18 years, male or female, with an expected survival of more than 3 months;
• Estimated creatinine clearance ≥ 50 mL/min;
• AST and ALT ≤ 3.0 x ULN (unless considered due to leukemia organ involvement), bilirubin ≤ 3.0 x ULN (unless considered due to leukemia organ involvement);
• ECOG ≤ 2;
• Subjects are non-pregnant or using contraceptive measures during treatment;
• Capable of understanding and voluntarily providing informed consent.