New drug cocktail aims to beat back tough leukemia
NCT ID NCT05305859
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This phase 2 trial is testing a combination of three drugs—venetoclax, chidamide, and azacitidine—in 30 adults with acute myeloid leukemia that has relapsed or not responded to prior treatment. The goal is to see if this combo can safely improve remission rates and survival. Participants must be 18 or older and have adequate organ function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- venetoclax, chidamide, and azacitidine (drug combination)
- What this could lead to
- If successful, this could offer a new treatment option for people with hard-to-treat acute myeloid leukemia that has come back or not responded to standard therapy.
- What could go wrong
- This is a small, early-phase trial with only 30 participants, so results may not apply to everyone. The drug combination may cause side effects and may not work for all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2022
- Expected to finish
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Jun 2027
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 years and older
- 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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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: 1. Creatinine clearance≥30 mL/min and serum Creatinine ≤ 160µmol/L 2. ALT and AST ≤ 3 × upper limit of normal (ULN) 3. Able to understand and sign an informed consent form (ICF). Exclusion Criteria: * Diagnosis of acute promyelocytic leukemia (APL) * Central nervous system leukemia * Uncontrolled or significant cardiovascular disease, including any of the following: 1. 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); 2. 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); 3. 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); 4. History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to Screening; 5. History of New York Heart Association Class 3 or 4 heart failure; 6. Complete left bundle branch block; 7. Known history of left ventricular ejection fraction (LVEF) ≤45% or less than the institutional lower limit of normal; * Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy; * 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 * Females who are pregnant or breastfeeding; * Mental disorders that hinder research participation * 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) * Any other situation where the investigator believes that the patient should not 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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Bing Xu
RECRUITINGXiamen, Fujian, 361003, China
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