Enasidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH2A Decentralized Trial

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT06240754
Phase
PHASE2
Status
Recruiting
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Conditions

  • CCUS Clonal Cytopenia of Undetermined Significance
  • Clonal Cytopenia of Undetermined Significance

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Enasidenib — DRUG
    Provided by BMS.

Study Details

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.

Key Dates

Start date
Oct 10, 2024
Status verified
May 2026
Primary completion
Jan 31, 2028
Completion
Feb 28, 2029

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Enasidenib
    Participants will receive enasidenib 100 mg daily for 18 cycles (each cycle is 28 days). Participants will continue treatment with enasidenib until confirmed progression to AML or MDS, development of unacceptable toxicity, or suspicion of disease progression, provided the patient is deriving clinical benefit, which will be determined at the discretion of the principal investigator.

Primary Outcome Measure

Best hematologic response [ Time Frame: Up to 18 cycles (each cycle is 28 days) of treatment (up to approximately 17 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Giulia Petrone, M.D.
[email protected]
314-362-6826
Giulia Petrone, M.D. (PRINCIPAL_INVESTIGATOR)

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By research site
Washington University School of Medicine· St Louis, MO

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