Study on Olutasidenib for Patients with Relapsed IDH1 Mutated Acute Myeloid Leukemia After Venetoclax Treatment

Sponsor: Timothy Pardee

Sponsor score: 0

ClinicalTrials ID:NCT07471841

Provider View

This clinical trial is testing the effectiveness of the drug Olutasidenib in patients with relapsed or treatment-resistant acute myeloid leukemia (AML) that has a specific IDH1 mutation and who have previously been treated with Venetoclax.

Patient Parameters

Program Overview

The study aims to evaluate how well Olutasidenib works in patients with relapsed or refractory acute myeloid leukemia (AML) that has a specific IDH1 mutation. Participants will take Olutasidenib pills twice daily for 28-day cycles. If after three cycles the cancer has not gone into complete remission, another drug, Azacitidine, may be added. Patients who show at least a partial response after six cycles will continue the treatment, while those who do not will enter a long-term follow-up phase.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a confirmed diagnosis of relapsed or treatment-resistant acute myeloid leukemia (AML) with an IDH1 mutation.
  • Must have previously received Venetoclax as part of their treatment.
  • Must have had no more than two previous treatment regimens.
  • Must be in good overall health with an ECOG performance status of 0 to 2.
  • Must have adequate kidney and liver function based on specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use effective contraception.
  • Men must agree to use effective contraception if engaging in sexual activity with a woman of childbearing potential.
  • People with controlled HIV or hepatitis infections may be eligible.
  • Must be able to understand and agree to follow the study procedures.

Exclusion Criteria

  • Previous treatment with Olutasidenib or any other IDH1 inhibitor.
  • Active infections requiring intravenous antibiotics.
  • Known involvement of AML in the central nervous system.
  • Recent stem cell transplant within the last 60 days.
  • Recent treatment with another investigational drug.
  • Severe allergic reactions to Olutasidenib or its ingredients.
  • Pregnant or breastfeeding women.
  • Other cancers that could interfere with the study.
  • Use of certain medications that affect how Olutasidenib works, unless stopped two weeks before starting the study.

Locations

FACILITYZIPCITYSTATE
Atrium Health Wake Forest Baptist Medical Center27157Winston-SalemNorth Carolina

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