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Anti-metabolites

Olutasidenib + Hypomethylating Agents for Blood Disorders

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

Be older than 18 years old

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 will test whether combining olutasidenib with a hypomethylating agent can help treat certain blood disorders like MDS, CMML, and MPN. The study will also look at

Who is the study for?

This trial is for patients with certain blood disorders like higher-risk myelodysplastic syndromes, chronic myelomonocytic leukemia, or advanced myeloproliferative neoplasm that have a specific mutation called IDH1. Detailed eligibility criteria are not provided.

What is being tested?

The study tests if olutasidenib combined with hypomethylating agents (either azacitidine or decitabine) can control these blood disorders better than current treatments. It also looks at the safety of this drug combination.

What are the potential side effects?

Specific side effects are not listed, but generally, drugs like olutasidenib and hypomethylating agents may cause fatigue, nausea, low blood counts leading to infection risk or bleeding problems, and potential liver issues.

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

3Treatment groups

Experimental Treatment

Group I: Olutasidenib+Decitabine/Cedazuridine-POExperimental Treatment3 Interventions

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.

Group II: Olutasidenib+Decitabine-IVExperimental Treatment2 Interventions

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.

Group III: Olutasidenib+Azacitidine-IV or SubQExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Decitabine

2004

Completed Phase 3

~1680

Azacitidine (AZA)

2012

Completed Phase 1

~10