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:

• People who are 18 years of age or older at the time of giving consent.
• People who have been diagnosed with Acute Myeloid Leukemia (AML) that has come back or has not responded to treatment, confirmed through a laboratory test on a tissue or cell sample.
• People whose AML has a specific genetic change called an IDH1 mutation, confirmed by testing.
• People whose AML did not respond to initial chemotherapy, or who received at least two cycles of a specific drug combination (HMA plus venetoclax) without achieving remission.
• People who have received no more than two rounds of prior treatment, and at least one of those treatments must have included a drug called venetoclax.
• People who are well enough to carry out basic daily activities, as measured by a standard health scoring tool called the ECOG scale (score of 0, 1, or 2), assessed within the 28 days before joining the trial.
• People whose kidneys, liver, and other organs are functioning at a level that meets specific laboratory thresholds, confirmed by blood tests taken within 14 days before joining.
• People whose side effects from previous treatments have mostly resolved and are rated as mild or moderate (Grade 2 or lower) at the time of screening.
• People who are able to become pregnant must have a negative blood pregnancy test within 7 days before starting treatment.
• People who could become pregnant or could father a child must be willing to either abstain from penile-vaginal intercourse or use effective contraception during the trial.
• People living with HIV may be considered eligible if they are on effective HIV treatment and their viral load has been undetectable within the 6 months before joining (HIV testing is not required at screening).
• People with a known history of chronic Hepatitis B may be considered eligible if their viral load is undetectable while on appropriate treatment (confirm with trial site).
• People with a history of Hepatitis C who have been successfully treated and cured may be considered eligible, and those currently being treated for Hepatitis C may be considered eligible if their viral load is currently undetectable (testing is not required at screening).
• People who are able to understand and follow all study procedures for the full duration of the trial, as assessed by the trial doctor.
• People must sign a written consent form and agree to the release of personal health information before joining.

Who may not be able to join:

• People who have previously been treated with ivosidenib or any other IDH1 inhibitor drug.
• People who currently have an active infection that requires intravenous (IV) antibiotic or antiviral treatment. (Note: people taking antibiotics as a preventive measure may still be considered eligible — confirm with trial site.)
• People whose AML has spread to the brain or spinal cord (central nervous system).
• People who have had a stem cell transplant using cells from another person within the 60 days before joining.
• People who have taken part in another clinical trial or received an experimental drug within 21 days (or within a specific timeframe based on the drug used) before joining.
• People who have had a severe allergic reaction to a drug called olutasidenib or any of its ingredients.
• People who are currently pregnant or breastfeeding. (Note: breast milk cannot be stored for later use during treatment.)
• People who have, or have had, another type of cancer whose disease or treatment could affect the safety or results of this trial, as determined by the treating doctor.
• People currently taking certain medications that strongly or moderately affect how the body processes drugs (called CYP3A inducers), such as phenobarbital, rifampicin, carbamazepine, or St John's Wort, unless a sufficient washout period has passed before starting treatment.
• People currently taking certain other medications that are processed through the same pathway as the trial drug (called sensitive CYP3A substrates), such as midazolam or simvastatin, unless a sufficient washout period has passed before starting treatment.

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