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IDH Inhibitor

Olutasidenib for Chronic Myelomonocytic Leukemia

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

Participants must have a documented IDH1 mutation with VAF ≥ 0.02

Participants ≥ 18 years old

Must not have

Participants unable to swallow oral medications, or patients with gastrointestinal conditions deemed by the Investigator to jeopardize intestinal absorption

Participants with any concurrent uncontrolled clinically significant medical condition, including life-threatening severe infection or psychiatric illness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if olutasidenib can help manage certain blood disorders, and it will also look at how safe the drug is.

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

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My cancer has a specific IDH1 mutation.

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I am 18 years old or older.

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My kidney function is within the required range.

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My condition is confirmed as CCUS or lower-risk MDS/CMML.

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I can take care of myself and am up and about more than half of the day.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot take pills by mouth or have a gut condition affecting drug absorption.

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I do not have any severe uncontrolled health or mental conditions.

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I do not have active hepatitis B, hepatitis C, or HIV.

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I am not pregnant, nursing, or if capable of childbearing, I am using effective birth control. The same applies to my male partner.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year.

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 9Eligibility criteria met