Not Yet RecruitingPhase 2

Chidamide Monotherapy for Intermediate-to-High-Risk Myelodysplastic Syndromes

China15 participantsStarted 2026-07-01

Plain-language summary

Myelodysplastic syndromes (MDS) are a group of bone marrow disorders that can cause low blood cell counts and may progress to acute leukemia. Treatment options for patients with intermediate-to-high-risk MDS are limited, especially for older patients or those who are not suitable for intensive chemotherapy or hypomethylating agents. Chidamide is an oral histone deacetylase inhibitor that has shown antitumor activity in several hematologic malignancies. This study aims to evaluate the effectiveness and safety of chidamide used alone in patients with intermediate-to-high-risk MDS. This is a prospective, single-arm, open-label phase II study conducted at a single center. Eligible participants will receive oral chidamide twice weekly and will be followed for treatment response and side effects. The results of this study may help determine whether chidamide could be a potential treatment option for patients with intermediate-to-high-risk MDS who have limited therapeutic choices.

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 se…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Overall Response Rate Assessed According to Study Protocol-Defined Response Criteria

Timeframe: Up to 6 months after initiation of study treatment

Trial details

NCT IDNCT07616336

SponsorZhongshan Hospital (Xiamen), Fudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03-31

Contact for this trial

Zheng Wei

+86-0592-3569860 wei.zheng@zs-hospital.sh.cn

View on ClinicalTrials.gov More Myelodysplastic Syndromes trials