Olutasidenib + Hypomethylating Agents for Blood Disorders

Overseen By Kelly Chien, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must be taking: Hypomethylating agents

Must not be taking: JAK inhibitors

Disqualifiers: Uncontrolled conditions, Active infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

45 Participants Needed

Trial Summary

What is the purpose of this trial?

To learn if olutasidenib, when combined with a drug called a hypomethylating agent (HMA) can help to control MDS, CMML, and/or MPN. The safety of the drug combination will also be studied.

Research Team

Kelly Chien, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

1. Pathologically proven higher-risk MDS/CMML or advanced MPN

1. MDS/CMML participants must have International Prognostic Scoring System (IPSS) intermediate-2- or high-risk disease or Revised IPSS (IPSS-R) score \> 3.5 or Molecular IPSS (IPSS-M) moderate high-, high-, or very high-risk disease or bone marrow blast percentage.

2. Advanced MPN is defined as bone marrow blast percentage \>/=10%.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive olutasidenib in combination with a hypomethylating agent. Olutasidenib is taken twice daily, and Azacitidine is administered IV or SubQ for 7 days every 28 days.

12 months

Monthly visits for Azacitidine administration

Follow-up

Participants are monitored for safety and effectiveness after treatment, including overall survival and progression-free survival.

4 weeks

Treatment Details

Interventions

• Azacitidine
• Decitabine
• Olutasidenib

Trial Overview 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.

Participant Groups

Group I: Olutasidenib+Azacitidine-IV or SubQ Experimental Treatment 1 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. Azacitidine IV or Sub Q for 7 days every 28 days.

Olutasidenib is already approved in United States for the following indications:

Approved in United States as Rezlidhia for:

• Acute Myeloid Leukemia (AML) with a susceptible IDH1 mutation

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Rigel Pharmaceuticals

Industry Sponsor

Trials

37

Recruited

4,000+