New oral drug chidamide tested for Hard-to-Treat bone marrow disorder
NCT ID NCT07616336
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests the drug chidamide (Tucidinostat) in 15 people aged 60 or older with intermediate-to-high-risk myelodysplastic syndromes (MDS), a bone marrow disorder that can lead to leukemia. Participants take chidamide orally twice a week for up to 3 months. The study aims to see if the drug can improve blood counts and bone marrow health, and to check for side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Chidamide (also called Tucidinostat), an oral drug
- What this could lead to
- If successful, this could point toward a new treatment option for people with intermediate-to-high-risk myelodysplastic syndromes who have few choices.
- What could go wrong
- This is a very small, early-phase trial with only 15 people. It may not show enough benefit or could have side effects that limit its use.
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 15 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- 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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60 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: * Aged 60 years or older at the time of informed consent. * Diagnosis of myelodysplastic syndromes (MDS) according to the World Health Organization (WHO) classification. * Intermediate-to-high-risk MDS, defined as at least one of the following: * International Prognostic Scoring System (IPSS) risk category of Intermediate-2 or High, with bone marrow blasts \<15%. * Revised International Prognostic Scoring System (IPSS-R) risk category of Intermediate, High, or Very High, with bone marrow blasts \<15%. * Intermediate-1 risk MDS with grade 1 to 3 anemia and not suitable for hypomethylating agent therapy. * Evidence of persistent cytopenia affecting one or more hematopoietic lineages for at least 4 months, unless MDS-associated cytogenetic abnormalities or increased blasts are present. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. * Adequate organ function as assessed by laboratory tests within 7 days before enrollment, including liver, renal, and cardiac function, in the opinion of the investigator. * Ability to understand and willingness to sign a written informed consent form. Exclusion Criteria: * Bone marrow blasts \>=15% at screening. * Prior treatment with chidamide. * Concurrent diagnosis of acute myeloid leukemia (AML) or other active hematologic malignancy. * Receipt of intensive chemotherapy, hypomethylating agents, or other investigational agents within 4 weeks before enrollment. * Uncontrolled active infection or severe concurrent medical condition that, in the investigator's judgment, would interfere with study participation. * Clinically significant cardiac disease, including uncontrolled arrhythmia or clinically relevant QT interval prolongation. * Known hypersensitivity to chidamide or any of its excipients. * Participation in another interventional clinical trial at the time of enrollment. * Any condition that, in the investigator's judgment, would make the participant unsuitable for participation in this study.
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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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Zhongshan Hospital (Xiamen), Fudan University
Xiamen, Fujian, 361015, China
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