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

29 mei 2026 bijgewerkt door: Zheng Wei, MD, Zhongshan Hospital (Xiamen), Fudan University

A Single-Arm, Open-Label Phase II Clinical Trial Evaluating the Efficacy and Safety of Chidamide Monotherapy in Participants With Intermediate-to-High-Risk Myelodysplastic Syndromes

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This is a prospective, open-label, single-arm phase II study designed to evaluate the efficacy and safety of chidamide monotherapy in participants with intermediate-to-high-risk myelodysplastic syndromes (MDS) who have limited therapeutic options or are not suitable for intensive chemotherapy or hypomethylating agent therapy.

Eligible participants will receive oral chidamide at an initial dose of 20 mg twice weekly. Each dose consists of four 5-mg tablets taken approximately 30 minutes after meals. Treatment may continue for up to 3 months, with a planned follow-up period of 6 months.

The primary objective is to evaluate the overall response rate (ORR) after chidamide treatment. Treatment response will be assessed according to hematologic response and bone marrow evaluation as specified in the study protocol. Secondary objectives include assessment of safety, tolerability, dose modification, treatment discontinuation, and changes in blood cell counts.

Participants will be followed for treatment response, adverse events, laboratory abnormalities, and overall clinical status for up to 6 months after initiation of study treatment.

Studietype

Ingrijpend

Inschrijving (Geschat)

15

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Fujian
      • Xiamen, Fujian, China, 361015
        • Zhongshan Hospital (Xiamen), Fudan University

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Chidamide Monotherapy
Participants in this arm will receive oral chidamide monotherapy for the treatment of intermediate-to-high-risk myelodysplastic syndromes. Chidamide will be administered twice weekly, with dose modification based on safety, tolerability, and hematologic response.
Geneesmiddel: Chidamide

Chidamide will be administered orally at an initial dose of 20 mg twice weekly. Each dose consists of four 5-mg tablets taken approximately 30 minutes after meals. Treatment may continue for up to 3 months, with a planned follow-up period of 6 months.

Dose modifications are permitted based on hematologic and non-hematologic toxicities. In the event of grade 3 or higher hematologic toxicity or clinically significant non-hematologic toxicity, chidamide will be temporarily withheld and may be resumed at a reduced dose after recovery, according to the investigator's judgment. Treatment will be discontinued if unacceptable toxicity persists despite dose interruption or dose reduction.

Andere namen:
  • Tucidinostaat

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall Response Rate Assessed According to Study Protocol-Defined Response Criteria
Tijdsspanne: Up to 6 months after initiation of study treatment
Overall response rate is defined as the proportion of participants who achieve a protocol-defined treatment response after chidamide treatment. Response assessment will be based on hematologic parameters and bone marrow evaluation, as specified in the study protocol.
Up to 6 months after initiation of study treatment

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of Treatment-Emergent Adverse Events
Tijdsspanne: Up to 6 months after initiation of study treatment
Treatment-emergent adverse events will be assessed based on clinical evaluation, laboratory testing, and investigator assessment during the study period.
Up to 6 months after initiation of study treatment
Proportion of Participants With Dose Interruption, Dose Reduction, or Treatment Discontinuation Due to Adverse Events
Tijdsspanne: Up to 6 months after initiation of study treatment
This outcome will assess the proportion of participants who require dose interruption, dose reduction, or permanent discontinuation of chidamide due to adverse events.
Up to 6 months after initiation of study treatment
Proportion of Participants Achieving Hematologic Improvement
Tijdsspanne: Up to 6 months after initiation of study treatment
Hematologic improvement will be assessed based on changes in peripheral blood counts and transfusion requirements according to the study protocol.
Up to 6 months after initiation of study treatment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Zhongshan Hospital (Xiamen), Fudan University

Onderzoekers

  • Hoofdonderzoeker: Zheng Wei, Zhongshan Hospital (Xiamen), Fudan University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

31 maart 2027

Studie voltooiing (Geschat)

30 juni 2027

Studieregistratiedata

Eerst ingediend

17 januari 2026

Eerst ingediend dat voldeed aan de QC-criteria

29 mei 2026

Eerst geplaatst (Werkelijk)

1 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

29 mei 2026

Laatst geverifieerd

1 juli 2025

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • B2025-040R

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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