RecruitingPhase 2NCT06566742
A Phase 2 Study Evaluating Olutasidenib in Patients With IDH1-mutated Clonal Cytopenia of Undetermined Significance and Lower-risk Myelodysplastic/Syndromes/Chronic Myelomonocytic Leukemia.
Sponsor
M.D. Anderson Cancer Center
Enrollment
15 participants
Start Date
Dec 10, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
To learn if olutasidenib can help to control CCUS, MDS, and/or CMML. The safety of the drug will also be studied.
Eligibility
Min Age: 18 Years
Plain Language Summary
Simplified for easier understanding
This study is testing olutasidenib — a targeted oral drug — in patients with a specific gene mutation called IDH1 who have clonal cytopenia of undetermined significance (CCUS) or lower-risk myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML). These are conditions where bone marrow does not produce blood cells properly.
**You may be eligible if...**
- You are 18 or older with confirmed CCUS, lower-risk MDS, or lower-risk CMML
- Your bone marrow or blood tests show a specific IDH1 mutation with a variant allele frequency of at least 2%
- You have low blood counts (anemia, low neutrophils, or low platelets) that are unexplained
- Your liver and kidney function are adequate
- You are in reasonably good health (ECOG 0–2)
**You may NOT be eligible if...**
- Your IDH1 mutation has not been confirmed
- You have high-risk MDS or AML (acute leukemia)
- You have significant liver, kidney, or heart problems
- You are pregnant or breastfeeding
- You are on certain conflicting medications (such as strong CYP3A4 inducers)
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
DRUGOlutasidenib
Given by PO
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06566742
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