Chiglitazar Sodium Combined With Venetoclax and Azacitidine (CVA) for the Treatment of R/R AML
Trial Parameters
Brief Summary
To investigate the safety and efficacy of the CVA regimen, composed of Chiglitazar Sodium in combination with Venetoclax and Azacitidine, in the treatment of patients with refractory/relapsed acute myeloid leukemia (R/R AML).
Eligibility Criteria
Inclusion Criteria: 1. 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; 2. Age ≥18 years, male or female, with an expected survival of more than 3 months; 3. Estimated creatinine clearance ≥ 50 mL/min; 4. 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); 5. ECOG ≤ 2; 6. Subjects are non-pregnant or using contraceptive measures during treatment; 7. Capable of understanding and voluntarily providing informed consent. Exclusion Criteria: 1. Acute promyelocytic leukemia (APL); 2. Active central nervous system leukemia; 3. Pati