Clinical Trial

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

Not Yet Recruiting Phase 2
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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.
Trial Details
NCT Number NCT07616336
Lead Sponsor Zhongshan Hospital (Xiamen), Fudan University
Conditions Myelodysplastic Syndromes
Enrollment 15 participants
Start Date 2026-07-01
Primary Completion 2027-03-31 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-01