Phase 2 Study of Olutasidenib with Hypomethylating Agents for Patients with IDH1-mutated Blood Disorders

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06597734

Provider View

This study is testing if the drug olutasidenib, combined with another type of medication, can help control certain blood disorders like MDS, CMML, and MPN. The study will also look at how safe this drug combination is for patients.

Patient Parameters

Program Overview

The purpose of this study is to find out if olutasidenib, when used with a type of medication called a hypomethylating agent (HMA), can help manage blood disorders such as higher-risk Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), and advanced Myeloproliferative Neoplasm (MPN). The study will also assess the safety of this drug combination.

Description

The main goal of this study is to see how well olutasidenib works with a hypomethylating agent (HMA) in treating patients with certain blood disorders that have a specific IDH1 mutation. Researchers will look at how many patients respond to the treatment and how long the response lasts. They will also check the safety and side effects of the treatment.

Secondary goals include:

  • Measuring the rates of complete remission and how long it lasts.
  • Evaluating the safety and tolerability of the drug combination.
  • Assessing survival rates, including overall survival and progression-free survival.
  • Analyzing changes in the size of the IDH1 mutation.

Exploratory goals include:

  • Studying the response rate in patients who have previously taken a drug called venetoclax.
  • Investigating genetic and molecular markers that might predict how well the treatment works or if there is resistance to it.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of higher-risk MDS, CMML, or advanced MPN.
    • MDS patients must have a specific risk score or bone marrow blast percentage.
    • CMML patients must have a specific risk level.
    • Advanced MPN is defined by a certain percentage of bone marrow blasts.
  • Must not have received a prior HMA if on the treatment-naive arm. Certain other medications are allowed.
  • Must have received a prior HMA and/or ivosidenib if on the previously-treated arm. Prior stem cell transplantation is allowed.
  • Must have a documented IDH1 mutation.
  • Patients with previously-treated MDS must not be eligible for ivosidenib or must have progressed on it.
  • Must be 18 years or older.
  • Must have a performance status score of 0 to 2.
  • Must have acceptable liver and kidney function based on specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 90 days after.
  • Men must agree not to donate sperm and women not to donate eggs during the study and for 90 days after.
  • Must be able and willing to sign informed consent before starting the study.

Exclusion Criteria

  • Cannot swallow pills or have conditions affecting digestion that might interfere with the study medication.
  • Have any uncontrolled serious medical condition or psychiatric illness that could increase the risk of participating in the study.
  • Must have stopped any previous chemotherapy at least one week before starting the study treatment. Patients with MPN must not be on JAK inhibitors at the start of the study.
  • Have active graft-versus-host disease after stem cell transplantation or are on certain medications for it.
  • Have active hepatitis B, hepatitis C, or HIV infection.
  • Are pregnant or breastfeeding, or not using effective contraception if of childbearing potential.
  • Have a high white blood cell count, unless controlled with hydroxyurea.
  • Are unwilling or unable to follow the study procedures or standard care.

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