A Multicenter, Prospective, Single-Arm Study of Venetoclax, Chidamide, and Chiglitazar Sodium (VCC) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
To evaluate the efficacy and safety of venetoclax, chidamide, and chiglitazar sodium (VCC) in patients with relapsed or refractory acute myeloid leukemia (R/R AML).
• Histologically confirmed acute myeloid leukemia (AML) with relapsed or refractory disease, including:
‣ Refractory AML, defined as failure to achieve remission after at least one prior treatment;
⁃ Relapsed AML, defined as ≥5% blasts in the bone marrow after a previous remission;
⁃ AML arising from myelodysplastic syndrome (including CMML) or myeloproliferative neoplasms (secondary AML or therapy-related AML \[t-AML\]) is also eligible.
• Age ≥18 years, regardless of sex, with an expected survival of \>3 months.
• Estimated creatinine clearance ≥50 mL/min.
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 × the upper limit of normal (ULN), unless the abnormality is considered attributable to leukemic organ involvement; total bilirubin ≤3.0 × ULN, unless the abnormality is considered attributable to leukemic organ involvement.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
• Participants must not be pregnant and must agree to use effective contraception during study treatment.
• Ability to understand the study and willingness to provide written informed consent.