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

NCT07471841 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-03-13

No results posted yet for this study

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.

Conditions

  • IDH1 Mutation
  • Relapsed / Refractory AML

Interventions

DRUG

Olutasidenib

Olutasidenib 150 mg orally twice a day

DRUG

Azacitidine (AZA)

Azacitidine 75 mg/m2 subcutaneously or IV (over 10-40 minutes)

Sponsors & Collaborators

  • Atrium Health Wake Forest Baptist

    collaborator OTHER

  • Rigel Pharmaceuticals

    collaborator INDUSTRY

  • Timothy Pardee

    lead OTHER

Principal Investigators

  • Timothy Pardee, MD, PhD · Atrium Health Wake Forest Baptist

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2028-06-30
Completion
2029-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07471841 on ClinicalTrials.gov