Venetoclax, Chidamide, and Chiglitazar Sodium (VCC) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Key facts
- Where
- Xiamen, ChinaSee the site
- Phase
- Phase 2
Where in China
- The First Affiliated hospital of Xiamen UniversityXiamen, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The First Affiliated Hospital of Xiamen University
- Trial code
- NCT07783100
- Record updated
- 24 August 2026
- Original description
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).Read full original descriptionShow less
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).
Inclusion: 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.
Exclusion: 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; 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; 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; Acute promyelocytic leukemia (APL); Active central nervous system leukemia.