Olutasidenib in Relapsed IDH1 Mutated AML Patients Who Have Previously Received Venetoclax
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTimothy Pardee
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 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 criteria
Qualifiers
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.
Age ≥ 18 years at the time of consent.
ECOG Performance Status of ≤ 2 within 28 days prior to registration.
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)
Disqualifiers
Previous exposure to ivosidenib or any IDH1 inhibitor.
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.
Known CNS involvement with AML.
Previous allogeneic stem cell transplant within 60 days prior to registration.
Trial design
Treatments tested in this trial
- Olutasidenib
- Azacitidine (AZA)
Treatment groups
25 Participants
are divided into 1 treatment groupSponsors and collaborators
Timothy Pardee
Lead sponsor
Hoosier Cancer Research Network
Sponsor institution
Atrium Health Wake Forest Baptist
Collaborator
Rigel Pharmaceuticals
Collaborator
Source ClinicalTrials.gov