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

Summary

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).

Eligibility

Inclusion Criteria:

1. 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.
2. Age ≥18 years, regardless of sex, with an expected survival of \>3 months.
3. Estimated creatinine clearance ≥50 mL/min.
4. 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.
5. Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
6. Participants must not be pregnant and must agree to use effective contraception during study treatment.
7. Ability to understand the study and willingness to provide written informed consent.

Exclusion Criteria:

1. Acute promyelocytic leukemia (APL).
2. Active central nervous system leukemia.
3. 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.
4. Active, uncontrolled severe infection.
5. Other non-hematologic malignancies within the previous 2 years.
6. Psychiatric disorders that may interfere with participation in the study.
7. 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.
8. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study.

Conditions2

Interventions1

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