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

Recruiting Phase 2 Interventional Study
IDH1 Mutation Relapsed / Refractory AML
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
25 (estimated)
Sponsor
Timothy Pardee · Other
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About 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 g…
Trial Locations
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Eligibility Criteria
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…
Contacts

Timothy Pardee

MD, PhD

Timothy.Pardee@wfusm.edu

CONTACT

Ahran Lee

317-634-5842

alee@hoosiercancer.org

CONTACT