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A Study of Enasidenib in People With Clonal Cytopenia of Undetermined Significance | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study of Enasidenib in People With Clonal Cytopenia of Undetermined Significance

A Pilot Study of Enasidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH2

NCT05102370•Memorial Sloan Kettering Cancer Center

Summary

Study researchers think that a drug called enasidenib may help people with clonal cytopenia of undetermined significance (CCUS) because the drug blocks the mutated IDH2 protein, which may improve blood cell counts. The purpose of this study is to find out whether enasidenib is a safe and effective treatment for CCUS.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥18 years at the time of signing the informed consent form.
•Willing and able to adhere to the study visit schedule and other protocol requirements.
•Unexplained cytopenia for at least 6 months. Cytopenia is defined as the presence of ≥1 blood count indexes below the following thresholds:
•Hgb \<10 g/dL
•ANC \<1.8 × 10\^9/L
•Platelets \<100 × 10\^9/L
•Results of bone marrow biopsy within 1 month of study entry (screening bone marrow biopsy) must not indicate hematologic disease.
•IDH2 gene mutation (R140 or R172), performed locally, at a frequency \>2%.
•ECOG performance status of 0-2.
•Adequate organ function, defined as:
+5 more criteria

Exclusion Criteria

•Active malignancy defined as \>1-cm disease on most recent CT scan in the past 6 months or recent history of cancer (i.e. within the past 5 years) with \>50% chance of cancer recurrence in the next 5 years.
•Current or prior history of hematologic malignancy.
•Therapy (including maintenance therapy) for solid-tumor malignancy within the last 6 months.
•Known dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally.
•Active uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment).
•Positive direct Coombs test
•Evidence of hypersplenism on physical exam
•Pregnant or lactating (women).

Locations (12)

Mayo Clinic (Data Collection Only)

Rochester, Minnesota, United States

Washington University (Data Collection and Specimen Analysis)

St Louis, Missouri, United States

Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (All protocol activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited protocol activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk-Commack (Limited protocol activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited protocol activities)

Rockville Centre, New York, United States

Cleveland Clinic (Data Collection Only)

Cleveland, Ohio, United States

Key Dates

Start Date

October 6, 2021

Primary Completion Date

January 26, 2026

Completion Date

January 26, 2026

Last Updated

January 27, 2026

Enrollment

ACTUAL participants

Conditions

Clonal Cytopenia of Undetermined SignificanceCCUS Clonal Cytopenia of Undetermined Significance

Interventions

Enasidenib

DRUG

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Enasidenib in People With Clonal Cytopenia of Undetermined Significance

Inclusion Criteria

Exclusion Criteria

Curcumin to Improve Inflammation and Symptoms in Patients With Clonal Cytopenia of Undetermined Significance, Low Risk Myelodysplastic Syndrome, and Myeloproliferative Neoplasms

Clonal Hematopoiesis and Therapy-Emergent Myeloid Neoplasms in Patients With Cancers, CHANCES Study

Luspatercept for Clonal Cytopenias of Uncertain Significance

Early Intervention in High Risk CCUS

Modulation of Stem Cell Differentiation in Individuals With High Risk Clonal Haematopoiesis