Study on Olutasidenib and Azacitidine for Treating IDH1-Mutated Acute Myeloid Leukemia After Previous Treatment

Sponsor: University of California, Davis

Sponsor score: 0

ClinicalTrials ID:NCT07304011

Provider View

This clinical trial is testing a combination of the drugs olutasidenib and azacitidine, followed by olutasidenib alone, to treat patients with a specific type of acute myeloid leukemia (AML) that has a mutation called IDH1. The study focuses on patients who have already been treated with venetoclax and a hypomethylating agent.

Patient Parameters

Program Overview

This phase II study is exploring how well the combination of olutasidenib and azacitidine works in treating patients with IDH1-mutated acute myeloid leukemia (AML) who have previously been treated with venetoclax and a hypomethylating agent. Olutasidenib and azacitidine may help stop cancer cells from growing by blocking certain enzymes. The study also looks at whether continuing olutasidenib alone can help keep the cancer from coming back.

Description

Participants in this study will take olutasidenib by mouth twice a day for 28 days in each cycle, along with azacitidine given either through a vein or under the skin for seven days in each cycle. This treatment cycle repeats every 28 days for up to four cycles, as long as the cancer does not progress and side effects are manageable. After this, participants will continue taking olutasidenib alone every 28 days. Throughout the study, participants will have bone marrow tests and blood samples taken to monitor their condition.

After finishing the study treatment, participants will have a follow-up visit within 30 days and then every four months until they choose to leave the study, are lost to follow-up, the study ends, or they pass away.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with acute myeloid leukemia (AML) with a specific mutation called IDH1, except for a type called acute promyelocytic leukemia.
  • Achieved a certain level of response to initial treatment with venetoclax and a hypomethylating agent.
  • The IDH1 mutation must be present in the bone marrow or blood at diagnosis or after starting previous treatment.
  • Currently receiving first-line treatment with venetoclax and a hypomethylating agent, with no more than four cycles completed.
  • Eligible to receive azacitidine as part of standard care.
  • In good general health with a performance status score of 2 or less.
  • No previous organ transplants.
  • Recovery from previous treatment side effects to a mild level.
  • Aged 18 or older.
  • Adequate kidney function.
  • Liver function within specified limits.
  • Blood clotting times within specified limits.
  • Women and men must agree to use effective birth control during the study and for 90 days after the last dose of olutasidenib.
  • Must provide informed consent before starting the study.

Exclusion Criteria

  • Previous treatment with IDH1 inhibitors.
  • Previous AML treatments other than venetoclax and a hypomethylating agent.
  • History of another cancer unless disease-free for at least 12 months.
  • Active central nervous system (CNS) metastases or other urgent medical conditions.
  • Previous stem cell transplant for non-AML reasons if certain conditions apply.
  • Recent radiation therapy or major surgery.
  • Difficulty swallowing or absorbing oral medications.
  • Severe heart conditions or recent heart attack.
  • Certain heart rhythm issues unless evaluated by a cardiologist.
  • Use of medications that affect heart rhythm unless stable.
  • Chronic use of corticosteroids unless at a low dose.
  • HIV positive.
  • Active, uncontrolled infections.
  • Uncontrolled metabolic disorders.
  • Pregnant, breastfeeding, or planning to become pregnant during or shortly after the study.
  • Plans to donate sperm or conceive a child during or shortly after the study.
  • Unable or unwilling to follow study procedures or provide informed consent.

Locations

FACILITYZIPCITYSTATE
University of California Davis Comprehensive Cancer Center95817SacramentoCalifornia

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