Tests chidamide with venetoclax and azacitidine in acute myeloid leukemia
Tests adding chidamide to venetoclax and azacitidine in adults with leukemia not responding well.
Plain-language title generated from the registry record
Registry title: VAC Regimen for AML Patients Who Failed to Response to VA Regimen
Key facts
- Where
- Suzhou, 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 with acute myeloid leukemia (AML) who cannot have intensive chemotherapy and whose disease did not respond enough to one cycle of venetoclax and azacitidine (VA).
- Age
- 18 to 80 years. People aged 60 or older can join. People aged 18 to 59 can join if they meet extra conditions.
- Sex
- Men and women can both join.
- Disease stage
- AML that did not respond enough to one cycle of VA, with at least 50% fewer blasts (leukemia cells) after VA. People aged 18 to 59 need an ECOG score of 2 or 3 and expected survival of 3 months or more. They also need severe heart, lung, liver or kidney disease, or another illness that rules out intensive chemotherapy.
- Earlier treatment
- Must have had one cycle of venetoclax and azacitidine (VA). No radiotherapy, other treatment, or stem-cell transplant in the 4 weeks before joining. No earlier chidamide. No other clinical trial in the last 3 months.
- Biomarker or test result
- People with FLT3 mutations who took targeted drugs can join only if they stop those drugs. People with BCR-ABL1 translocation cannot join.
Main reasons for not taking part
- History of myeloproliferative neoplasms or chronic myeloid leukemia, or leukemia with BCR-ABL1 translocation
- Fewer than 50% blasts removed after the VA regimen
- Active leukemia in the brain or spinal cord (CNS)
- Uncontrolled active infection or organ bleeding
- Pregnant or breastfeeding women
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06220162, who can take part
Where in China
- The First Affiliated Hospital of Soochow UniversitySuzhou, ChinaContact: Sheng-Li N Xue, M.D.Taking 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 Soochow University
- Trial code
- NCT06220162
- Record updated
- 19 March 2026
- Original description
Chidamide in combination with venetoclax and azacitidine (VAC) were expected to improve remission rate of patients following to VA regimen treatment failure.Read full original descriptionShow less
A Clinical Study of Chidamide in Combination With Venetoclax and Azacitidine (VAC) for Patients With Acute Myeloid Leukemia Who Did Not Achieve CR/CRi/MLFS (PR or NR) With One Cycle of Venetoclax and Azacitidine (VA).
Chidamide in combination with venetoclax and azacitidine (VAC) were expected to improve remission rate of patients following to VA regimen treatment failure.
Inclusion: Patients with AML who are not suitable for intensive chemotherapy according to the WHO diagnosis: age ≥60 years or age <60 years but fulfil the following criteria; Age 18 to 59 years; Eastern Cooperative Oncology Group (ECOG) physical status score of 2 or 3; Expected survival time ≥3 months; Or fulfilment of severe cardiac, pulmonary, hepatic, or renal disease; (A) Presence of a cardiac history of congestive heart failure, or ejection fraction ≤ 50%, or presence of chronic stable angina; (B) Lung carbon monoxide diffusing capacity (DLCO) ≤ 65%, or first forced expiratory volume (FEV1) ≤ 65%; (C) Moderate hepatic impairment with total bilirubin > 1.5 to ≤ 3.0 x upper limit of normal (ULN); (D) Creatinine clearance ≥ 30 mL/min to < 45 mL/min; Not received radiotherapy, treatment regimens other than the VA regimen, or haematopoietic stem cell transplantation within 4 weeks prior to enrolment; Other comorbidities that, in the judgement of the physician, make the administration of intensive chemotherapy unsuitable; Ability to understand and willingness to sign the informed consent for this trial; The patient refuses intensive chemotherapy and has the willingness to accept non-intensive chemotherapy.
Exclusion: Patients with FLT3 mutations and who were treated with targeted agents (inclusion is possible if the use of specific targeted agents is discontinued); With prior treatment with chidamide; Participation in any other clinical trial within 3 months prior to VAC regimen; Patients with a history of myeloproliferative neoplasms (MPN), including myelofibrosis, thrombocythemia, polycythaemia vera, chronic granulocytic leukemia (CML) with or without BCR-ABL1 translocation, and AML or acute promyelocytic leukemia (APL) with BCR-ABL1 translocation; Clinically uncontrolled active infections (including bacterial, fungal or viral infections) and organ hemorrhage; With other malignant tumours; With uncontrolled mental disorders; Any other condition that, in the opinion of the investigator, makes it inappropriate to participate in this trial; Patients with less than 50% reduction of blasts after VA regimen; Patients with active CNS involvement; Pregnant or lactating women.