Venetoclax, chidamide and azacitidine for acute myeloid leukemia that returned or did not respond
Tests venetoclax, chidamide and azacitidine in adults with relapsed or refractory acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of R/R AML
Key facts
- Where
- Xiamen, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults whose acute myeloid leukemia (AML) has come back or has not responded to treatment. It tests venetoclax with chidamide and azacitidine.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Relapsed or refractory acute myeloid leukemia, confirmed by morphology and immunology tests
- Earlier treatment
- Earlier stem cell transplant is allowed, but not if the person has graft-versus-host disease (GVHD) or still takes immunosuppression or GVHD treatment. Previous solid organ transplant is not allowed.
Main reasons for not taking part
- Acute promyelocytic leukemia (APL)
- Leukemia in the central nervous system
- Uncontrolled or significant heart disease
- Active infection that is not well controlled by treatment
- Pregnant or breastfeeding women
Read by machine on 12 November 2026.
Where in China
- Bing XuXiamen, ChinaContact: Bing XuTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- The First Affiliated Hospital of Xiamen University
- Trial code
- NCT05305859
- Record updated
- 11 September 2025
- Original description
The purpose of this study is to evaluate the safety and efficacy of Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of relapsed and/or refractory AMLRead full original descriptionShow less
A Multi-center, Prospective, Single-arm Study of Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of Refractory/Relapsed Acute Myelogenous Leukemia (R/R AML)
The purpose of this study is to evaluate the safety and efficacy of Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of relapsed and/or refractory AML
Inclusion: Age ≥18; Relapsed and refractory patients with acute myeloid leukemia via morphology and immunology; ECOG：0-2; Life expectancy ≥ 3 months; Adequate laboratory parameters during the screening period as evidenced by the following:; Creatinine clearance≥30 mL/min and serum Creatinine ≤ 160µmol/L; ALT and AST ≤ 3 × upper limit of normal (ULN); Able to understand and sign an informed consent form (ICF).
Exclusion: Suffered from other non-myeloid malignancies within 2 years, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease; Previous solid organ transplantation (SCT treatment is allowed in advance, but if the patient has GVHD or is still receiving immunosuppression/GVHD treatment, it is not allowed); Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy; Mental disorders that hinder research participation; Uncontrolled or significant cardiovascular disease, including any of the following:; Bradycardia of less than 50 beats per minute, unless the subject has a pacemaker; Diagnosis of or suspicion of long QT syndrome (including family history of long QT syndrome); Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg; History of clinically relevant ventricular arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes); History of second (Mobitz II) or third degree heart block (subjects with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker); History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to Screening; History of New York Heart Association Class 3 or 4 heart failure; Complete left bundle branch block; Known history of left ventricular ejection fraction (LVEF) ≤45% or less than the institutional lower limit of normal; Diagnosis of acute promyelocytic leukemia (APL); Central nervous system leukemia; Females who are pregnant or breastfeeding; Any other situation where the investigator believes that the patient should not participate in this trial.