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
• People who have been diagnosed with acute myeloid leukaemia (AML) that has not yet been treated, where the disease is present in the bone marrow or blood (people whose AML is only found outside the bone marrow and blood are not eligible)
• People whose AML has a specific gene change called an IDH1 mutation, specifically one of these types: R132C, R132G, R132H, R132L, or R132S
• People who have a general health/activity level rated 0, 1, or 2 on a standard medical scale (meaning they are fully active, have some limitations but can care for themselves, or are up and about more than half the day)
• People whose liver is functioning well enough, based on blood test results within accepted ranges (confirm with trial site)
• People whose kidneys are functioning well enough, based on blood test results within accepted ranges (confirm with trial site)
• People who agree to have blood and bone marrow samples taken at several points during the trial
• People who are able to understand the trial information and are willing to sign a consent form
• People who are willing to complete quality-of-life questionnaires during and after treatment
• Women who could become pregnant must have a negative pregnancy blood test before starting the trial, and both women who could become pregnant and men with female partners who could become pregnant must use two effective forms of contraception (including at least one barrier method such as a condom) from the time of signing consent until 90 days after the last dose of study medication

Who may not be able to join:

• People who have already received treatment for AML, except for certain non-chemotherapy medicines used to temporarily stabilise the disease (such as hydroxyurea or a procedure to reduce white blood cells called leukapheresis)
• People who have previously been treated with a type of medicine called a hypomethylating agent for a condition called myelodysplastic syndrome (MDS)
• People whose AML has certain specific chromosome changes that are considered lower-risk (such as t(8;21), inv(16), t(16;16), or t(15;17))
• People who have a specific type of leukaemia called acute promyelocytic leukaemia
• People who have previously been treated for a related blood disorder and have not yet waited long enough since their last treatment dose (a waiting period of at least 5 half-lives of that medicine must have passed — confirm with trial site)
• People who have previously been treated with a medicine that blocks IDH1 or a medicine called a BCL-2 inhibitor
• People who have a known allergy or sensitivity to any ingredient in the study medicines: ivosidenib, venetoclax, or azacitidine
• Women who are currently pregnant or breastfeeding
• People who are taking certain medicines that strongly interact with how the body processes the study drugs, unless those medicines can be safely switched to an alternative at least 5 half-lives before starting the trial
• People who have an active, serious infection (fungal, bacterial, or viral) that is not improving with appropriate treatment
• People who have had another type of cancer in the past, unless they have been free of that cancer for at least 1 year before starting the trial — exceptions may apply for certain minor skin cancers or cervical changes in situ (confirm with trial site)
• People who have had a significant heart condition in the past 6 months, such as severe heart failure, a heart attack, unstable chest pain, or a stroke
• People who have an abnormal heart electrical reading (specifically a QTcF interval greater than 470 msec) or other factors that increase the risk of heart rhythm problems — some exceptions may apply (confirm with trial site)
• People who have HIV or an active hepatitis B or C infection that cannot be controlled with treatment
• People who have difficulty swallowing or a condition that prevents them from properly absorbing medicines taken by mouth
• People who have uncontrolled high blood pressure (systolic above 180 mmHg or diastolic above 100 mmHg)
• People who have symptoms suggesting leukaemia has spread to the brain or spinal fluid, or who are known to have this
• People who have severe, life-threatening complications from leukaemia at the time of enrolment, such as uncontrolled bleeding, serious lung infection, or a serious blood-clotting disorder
• People who have any other medical or psychological condition that the trial doctor believes would prevent them from safely participating or giving informed consent
• People who are taking medicines known to affect heart rhythm (QT interval), unless those medicines can be safely switched or closely monitored (confirm with trial site)
• People who have a known history of a serious brain condition called progressive multifocal leukoencephalopathy

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