Venetoclax, Chidamide, and Chiglitazar Sodium (VCC) in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Korábbi kezelés

• Other non-hematologic malignancies within the previous 2 years.
• Previous solid organ transplantation. Prior stem cell transplantation (SCT) is permitted; however, patients with graft-versus-host disease (GVHD) or those receiving ongoing immunosuppressive or GVHD-directed therapy are not eligible.

Más betegség

• Active, uncontrolled severe infection.
• Psychiatric disorders that may interfere with participation in the study.
• Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study.

Laborértékek

• Clinically significant cardiovascular disease, including any of the following:
  • Clinically significant QTc prolongation (QTc \>450 ms in males or \>470 ms in females);
  • Ventricular tachycardia;
  • Second-degree atrioventricular block;
  • Myocardial infarction within 1 year prior to enrollment;
  • Congestive heart failure;
  • Coronary artery disease requiring medical treatment.

Egyéb

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

• 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.