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Clinical Trials in China / NCT07783100
Recruiting Phase 2

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

NCT07783100 · tracked via the Priya Life Science China tracker
Sponsor
The First Affiliated Hospital of Xiamen University
Phase
Phase 2
Started
2026-11-11
Last updated
2026-08-24

Condition(s) studied

Relapsed or Refractory Acute Myeloid Leukemia

Investigational drug(s) / intervention(s)

venetoclax, chidamide, and chiglitazar sodium (VCC)

venetoclax, chidamide, and chiglitazar sodium (VCC): 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
the First affiliated hospital of xiamen university Xiamen Fujian Recruiting

More The First Affiliated Hospital of Xiamen University trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07783100 on ClinicalTrials.gov ↗ ← All trials in China