Actively Recruiting
Enasidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH2A Decentralized Trial
Led by Washington University School of Medicine · Updated on 2026-02-11
15
Participants Needed
1
Research Sites
228 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Enasidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH2A Decentralized Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Unexplained cytopenia lasting at least 6 months with at least one blood count below specific levels (Hgb <10 g/dL, ANC <1.8 x 10^9/L, or platelets <100 x 10^9/L)
- Presence of an IDH2 gene mutation (R140 or R172) at a frequency of 2% or higher
- Age 18 years or older
- ECOG performance status of 0 to 2
- Adequate organ function including liver enzymes up to 3 times the upper limit, bilirubin less than 1.5 times the upper limit (or up to 5 mg/dL if due to Gilbert's syndrome), and creatinine clearance over 50 mL/min or serum creatinine less than twice the upper limit
- Agreement to use adequate contraception before, during, and after the study as specified
- Ability to understand and sign informed consent or have a legal representative do so
You will not qualify if you...
- Evidence of hematologic disease progression from bone marrow biopsy within 6 months before study entry
- Active cancer with tumors larger than 1 cm on recent CT scan within 6 months
- Receiving or recently received treatment for solid tumors within the last 6 months
- Receiving any other investigational drugs
- Known swallowing or absorption disorders affecting oral medication
- History of allergic reactions to enasidenib or similar compounds
- Uncontrolled illnesses such as active infection, heart failure, unstable angina, or arrhythmia
- Pregnant or breastfeeding, or positive pregnancy test within 72 hours before study entry
- Positive direct Coombs test
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
G
Giulia Petrone, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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