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IDH Inhibitor

Olutasidenib for Clonal Cytopenia

Phase 2
Waitlist Available
Led By Kelly Chien, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Pathologically proven CCUS or lower-risk MDS/CMML
1. CCUS is defined as the presence of cytopenia (absolute neutrophil count \< 1.8 x 109/L, hemoglobin \< 13 g/dL in males or \< 12 g/dL in females, and/or platelets \< 150 x 109/L) for at least 30 days that are otherwise unexplained and with no diagnostic hematopathologic features of myeloid neoplasms.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights

Summary

To learn if olutasidenib can help to control CCUS, MDS, and/or CMML. The safety of the drug will also be studied.

Who is the study for?
This trial is for patients with specific blood disorders: Clonal Cytopenia of Undetermined Significance (CCUS), lower-risk Myelodysplastic Syndromes (MDS), or Chronic Myelomonocytic Leukemia (CMML). Participants must have a mutation in the IDH1 gene. Detailed eligibility criteria are not provided, but typically include age, health status, and previous treatments.
What is being tested?
The study is testing Olutasidenib's effectiveness in controlling CCUS, MDS, and CMML in patients with an IDH1 mutation. It's a Phase 2 trial which means it focuses on the drug’s efficacy and monitoring its safety.
What are the potential side effects?
Specific side effects of Olutasidenib aren't listed here; however, common side effects from drugs treating similar conditions may include fatigue, nausea, diarrhea, liver issues, and potential risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and adverse events (AEs)

Trial Design

1Treatment groups
Experimental Treatment
Group I: OlutasidenibExperimental Treatment1 Intervention
Participants will take capsules of olutasidenib 2 times each day while you are on study. Each dose should be taken about 12 hours apart at least 1 hour before or 2 hours after a meal.

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,030 Previous Clinical Trials
1,797,232 Total Patients Enrolled
Rigel PharmaceuticalsIndustry Sponsor
33 Previous Clinical Trials
3,888 Total Patients Enrolled
Kelly Chien, MDPrincipal InvestigatorM.D. Anderson Cancer Center
~10 spots leftby Aug 2027
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