New hope for leukemia patients who didn't respond to standard therapy
NCT ID NCT06220162
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding chidamide to the standard venetoclax and azacitidine (VA) regimen can help people with acute myeloid leukemia (AML) who did not improve after one cycle of VA alone. About 32 adults aged 18 or older who are not candidates for intensive chemotherapy will receive the three-drug combination. The main goal is to see if more patients achieve remission.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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; 1. Age 18 to 59 years; 2. Eastern Cooperative Oncology Group (ECOG) physical status score of 2 or 3; 3. Expected survival time ≥3 months; 4. 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; 5. Not received radiotherapy, treatment regimens other than the VA regimen, or haematopoietic stem cell transplantation within 4 weeks prior to enrolment; 6. Other comorbidities that, in the judgement of the physician, make the administration of intensive chemotherapy unsuitable; 7. Ability to understand and willingness to sign the informed consent for this trial; 8. The patient refuses intensive chemotherapy and has the willingness to accept non-intensive chemotherapy. Exclusion Criteria: 1. 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; 2. Patients with FLT3 mutations and who were treated with targeted agents (inclusion is possible if the use of specific targeted agents is discontinued); 3. Patients with less than 50% reduction of blasts after VA regimen; 4. Patients with active CNS involvement; 5. With prior treatment with chidamide; 6. Clinically uncontrolled active infections (including bacterial, fungal or viral infections) and organ hemorrhage; 7. Pregnant or lactating women; 8. Participation in any other clinical trial within 3 months prior to VAC regimen; 9. With other malignant tumours; 10. With uncontrolled mental disorders; 11. Any other condition that, in the opinion of the investigator, makes it inappropriate to participate in this trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Affiliated Hospital of Soochow University
RECRUITINGSuzhou, Jiangsu, 215006, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can an HDAC inhibitor wipe out residual leukemia cells?
- Can an experimental pill block a cancer-driving enzyme in hard-to-treat leukemia?
- Two-Drug combo targets leukemia that outsmarted its first treatment
- Tweaking donor cells may shield older transplant patients from a dangerous complication
- Can a drug and donor cells stop leukemia from returning after transplant?