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).
This is a multicenter, prospective, single-arm clinical study evaluating the efficacy and safety of venetoclax, chidamide, and chiglitazar sodium (VCC) in patients with relapsed or refractory acute myeloid leukemia (R/R AML). Participants will receive VCC combination therapy according to the study protocol. The primary objective is to evaluate the antileukemic efficacy of the VCC regimen, while safety and tolerability will also be assessed throughout the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Participants will receive oral chidamide 30 mg twice weekly for 2 weeks, venetoclax 200 mg once daily for 2 weeks, and chiglitazar sodium 48 mg once daily on Days 1-28 of each 28-day cycle. At least two cycles will be administered. Dose modifications are permitted according to clinical condition, laboratory findings, adverse events, and venetoclax plasma concentrations.
the First affiliated hospital of xiamen university
Xiamen, Fujian, China
RECRUITINGComposite Complete Remission Rate (CR + CRi)
The proportion of participants who achieve complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) following VCC treatment. Treatment response will be assessed according to the response criteria specified in the study protocol.
Time frame: Up to 12 months
1-Year Progression-Free Survival (PFS)
The proportion of participants who are alive without disease progression at 1 year after initiation of VCC treatment. Progression-free survival is defined as the time from initiation of study treatment to disease progression or death from any cause, whichever occurs first.
Time frame: Up to 12 months
1-Year Overall Survival (OS)
The proportion of participants who are alive at 1 year after initiation of VCC treatment. Overall survival is defined as the time from initiation of study treatment to death from any cause.
Time frame: Up to 12 months
Change in Health-Related Quality of Life Assessed by EQ-5D-5L
Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. Changes in patient-reported health status during treatment will be evaluated relative to baseline.
Time frame: Up to 24 months
Incidence of Adverse Events
The incidence and severity of adverse events occurring during study treatment will be assessed based on clinical symptoms, physical examinations, vital signs, laboratory findings, and other clinically relevant safety parameters. Adverse events will be graded according to the toxicity grading criteria specified in the study protocol.
Time frame: Up to 12 months
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