Actively Recruiting
A Phase 2 Study Evaluating Olutasidenib in Patients With IDH1-mutated Clonal Cytopenia of Undetermined Significance and Lower-risk Myelodysplastic/Syndromes/Chronic Myelomonocytic Leukemia.
Led by M.D. Anderson Cancer Center · Updated on 2026-03-04
15
Participants Needed
1
Research Sites
246 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
R
Rigel Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
To learn if olutasidenib can help to control CCUS, MDS, and/or CMML. The safety of the drug will also be studied.
CONDITIONS
Official Title
A Phase 2 Study Evaluating Olutasidenib in Patients With IDH1-mutated Clonal Cytopenia of Undetermined Significance and Lower-risk Myelodysplastic/Syndromes/Chronic Myelomonocytic Leukemia.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed CCUS or lower-risk MDS/CMML
- CCUS defined as unexplained cytopenia for at least 30 days with specific blood count thresholds
- Lower-risk MDS/CMML defined by IPSS and IPSS-R scores and molecular risk categories
- Documented IDH1 mutation with variant allele frequency 0.02 or higher
- Age 18 years or older
- ECOG performance status 0 to 2
- Bilirubin less than or equal to 2 times upper limit of normal or 3 times in Gilbert Syndrome
- AST, ALT, and alkaline phosphatase less than or equal to 3 times upper limit of normal
- Acceptable kidney function with serum creatinine less than or equal to 1.5 times upper limit of normal or creatinine clearance above 50 mL/min
- Negative pregnancy test for females of childbearing potential
- Use of highly effective contraception for fertile men and women during and 90 days after study
- Agreement not to donate sperm or ova during study and 90 days after last dose
- Ability and willingness to provide informed consent
You will not qualify if you...
- Unable to swallow oral medications or have gastrointestinal conditions affecting drug absorption
- Uncontrolled significant medical conditions or severe infections
- Known active hepatitis B, hepatitis C, or HIV infection
- Pregnant or nursing women, or women of childbearing potential not using effective contraception; men not using effective contraception
- White blood cell count greater than 25 x 10^9/L (hydroxyurea use allowed to meet this)
- Unwilling or unable to comply with study or standard care procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
K
Kelly Chien, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here