Olutasidenib for Acute Myeloid Leukemia

Overseen By Ahran Lee

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Timothy Pardee

Must be taking: Venetoclax

Must not be taking: CYP3A inducers, CYP3A substrates

Disqualifiers: Ivosidenib, CNS involvement, 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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 cycles (approximately 6 months)

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a prospective, single-arm phase 2 pilot study to assess the response rate of IDH1 mutated relapsed/refractory acute myeloid leukemia (AML) patients who receive olutasidenib after progressing on venetoclax based regimens. Each cycle will last for 28 days. Patients will receive olutasidenib 150 mg orally twice daily Day 1 through Day 28. After 3 cycles of olutasidenib, azacitidine 75 mg/m2 given on Day 1 through Day 7 may be added at the discretion of the treating investigator if the patient has not achieved a complete remission. Subjects with at least a PR after 6 cycles of treatment will continue treatment as previously described. Subjects without at least a partial response (PR) after 6 cycles of treatment will move to long term follow up.

Who Is on the Research Team?

Timothy Pardee, MD, PhD

Principal Investigator

Atrium Health Wake Forest Baptist

Are You a Good Fit for This Trial?

Inclusion Criteria

I have acute myeloid leukemia with an IDH1 mutation.

1. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.

I have had no more than two previous treatments, including one with venetoclax.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive olutasidenib 150 mg orally twice daily for 28-day cycles. After 3 cycles, azacitidine may be added if no complete remission is achieved.

6 cycles (approximately 6 months)

Follow-up

Participants are monitored for safety and effectiveness after treatment. Subjects without at least a partial response after 6 cycles will move to long-term follow-up.

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Azacitidine
• Olutasidenib

How Is the Trial Designed?

Group I: Olutasidenib and Azacitidine Experimental Treatment 2 Interventions

Each cycle will last for 28 days. Patients will receive olutasidenib 150 mg orally twice daily Day 1 through Day 28. After 3 cycles of olutasidenib, azacitidine 75 mg/m2 given on Day 1 through Day 7 may be added at the discretion of the treating investigator if the patient has not achieved a complete remission or for whom loss of response is suspected. Subjects with at least a PR after 6 cycles of treatment will continue treatment.. Subjects without at least a PR after 6 cycles of treatment will move to long term follow up.

Who Is Running the Clinical Trial?

Timothy Pardee

Lead Sponsor

Rigel Pharmaceuticals

Industry Sponsor

Trials

37

Recruited

4,000+

Atrium Health Wake Forest Baptist

Collaborator