Phase 2 Leukaemia Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults between 18 and 75 years old who doctors consider suitable for intensive chemotherapy treatment
• People with a performance status score of 2 or less on a standard scale that measures how much a person's daily activities are affected by their illness (confirm with trial site)
• People with a newly diagnosed form of blood cancer called AML that has a specific gene change known as IDH1 R132 mutation, confirmed by recent testing
• People whose AML developed from a previous blood disorder, including those who were previously treated with certain medications (called hypomethylating agents) for related blood conditions
• People whose liver is functioning within acceptable levels based on specific blood test results
• People whose kidneys are functioning at an adequate level based on blood or urine tests
• People who have recovered from most side effects of any previous treatment before starting this trial
• People whose heart's electrical activity (measured by a specific interval on a heart tracing called QTcF) is within an acceptable range
• Women who could potentially become pregnant must have a negative pregnancy test before starting the trial
• Women who could become pregnant, and men whose partners could become pregnant, must agree to use reliable contraception during the trial and for at least 3 months after the last dose
• Participants must agree not to donate or retrieve eggs or sperm from the time they join the trial until 3 months after the last dose
• People who are willing and able to follow all study requirements and give written consent

Who may not be able to join:

• People whose AML has come back or has not responded to previous treatment
• People whose AML is classified as "favorable risk" according to a specific 2022 medical guideline, unless they have a particular gene change called NPM1 mutation
• People with a specific type of blood cancer called acute promyelocytic leukemia (APL)
• People whose AML has a specific gene change called FLT3-ITD mutation
• People whose leukemia has spread to the brain or spinal cord fluid
• People younger than 18 or older than 75
• Women who are pregnant or breastfeeding
• People who plan to become pregnant, father a child, or donate eggs or sperm during the trial or within 3 months after the last dose
• People with a known allergy or serious reaction to any of the study drugs or their ingredients
• People who have previously been treated with specific drugs used in this trial, including olutasidenib, ivosidenib, other IDH1 inhibitors, venetoclax, or similar drugs
• People with serious uncontrolled medical conditions such as uncontrolled infection, severe metabolic problems, poorly managed mental health conditions, or significant heart disease
• People currently taking certain medications that strongly affect how the body processes drugs (called strong CYP3A inhibitors or inducers), unless enough time has passed since stopping them (confirm with trial site for exact timing)
• People who have had a stem cell transplant for a condition other than AML and are still experiencing significant transplant-related complications or need ongoing immune-suppressing medications above a certain level
• People currently being treated for another active cancer
• People with a known active hepatitis B, hepatitis C, or HIV infection with a detectable viral load
• People who have had major surgery within 28 days before starting the trial, or who have not fully recovered from surgery
• People who are not able to make their own informed decisions about participating

Important: Always verify eligibility with the trial site directly before applying.