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Olutasidenib in Relapsed IDH1 Mutated AML Patients Who Have Previously Received Venetoclax | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

Olutasidenib in Relapsed IDH1 Mutated AML Patients Who Have Previously Received Venetoclax

Pilot Single Arm Phase 2 Study of Olutasidenib in Relapsed IDH1 Mutated AML Patients Who Have Previously Received Venetoclax

NCT07471841•Timothy Pardee

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
•2. Age ≥ 18 years at the time of consent.
•3. ECOG Performance Status of ≤ 2 within 28 days prior to registration.
•4. Must have histologically or cytologically documented relapsed and/or refractory Acute Myeloid Leukemia (Refractory is defined as failure to achieve a CR after induction chemotherapy or a minimum of two cycles of HMA plus venetoclax)
•5. Acute Myeloid Leukemia with a documented IDH1 mutation.
•6. No more than 2 lines of prior therapy. NOTE: One line of therapy must have contained venetoclax.
•7. Persisting, non-hematologic and non-infectious toxicities from prior treatment must be Grade ≤ 2. NOTE: Documentation of these criteria is required at screening.
•8. Demonstrate adequate organ function as defined in the table below. All screening labs to be obtained within 14 days prior to registration.
•* Renal
•* Calculated creatinine clearance (Cockcroft-Gault formula will be used to calculate creatinine clearance) ≥ 30 mL/min
+7 more criteria

Exclusion Criteria

•1. Previous exposure to ivosidenib or any IDH1 inhibitor.
•2. Active infection requiring IV systemic therapy. NOTE: Subjects receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.
•3. Known CNS involvement with AML.
•4. Previous allogeneic stem cell transplant within 60 days prior to registration.
•5. Treatment with any investigational drug within 21 days or 2 half-life's prior to registration.
•6. History of severe allergic anaphylactic reactions to olutasidenib or any of their excipients.
•7. Pregnant or breastfeeding. NOTE: breast milk cannot be stored for future use while the subject is being treated on study.
•8. Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen, per treating physician discretion.
•9. Concomitant use of known strong (e.g. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (e.g. bosentan, efavirenz, modafinil). The required washout period prior to starting olutasidenib is 2 weeks or 5 half-lives (whichever is longer) prior to initiation of treatment.
•10. Concomitant use of known sensitive CYP3A substrates (e.g. Midazolam, simvastatin, fluticasone, budesonide). The required washout period prior to starting olutasidenib is 2 weeks or 5 half-lives (whichever is longer) prior to initiation of treatment.

Locations (1)

Atrium Health Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Key Dates

Start Date

May 1, 2026

Primary Completion Date

June 1, 2028

Completion Date

June 1, 2029

Last Updated

March 13, 2026

Enrollment

ESTIMATED participants

Conditions

IDH1 MutationRelapsed / Refractory AML

Interventions

Olutasidenib

DRUG

Azacitidine (AZA)

DRUG

Contacts

Timothy Pardee

CONTACT

MD, PhD tspardee@wakehealth.edu

Ahran Lee

CONTACT

317-634-5842 alee@hoosiercancer.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Olutasidenib in Relapsed IDH1 Mutated AML Patients Who Have Previously Received Venetoclax

Inclusion Criteria

Exclusion Criteria

Niraparib In Recurrent IDH 1/2 Gliomas

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