Phase 4 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 aged 18 or older at the time of signing the consent form.
• People whose general health and ability to carry out daily activities meets a standard level of functioning (rated on a medical scale from 0–2, where 0 is fully active and 2 means limited in physical activity but able to care for oneself) (confirm with trial site).
• People who have largely recovered from side effects of previous cancer treatments, with only mild or no remaining effects (not counting hair loss, infertility, or mild nerve-related symptoms).
• People who have been diagnosed with a cancer that has a specific gene change called IDH1 mutation — for example, acute myeloid leukaemia (a blood cancer), certain gastrointestinal cancers, or glioma (a brain tumour) — and who are planned to be treated with a drug called olutasidenib, and who have not received olutasidenib in the two weeks before starting the study drug.
• People whose liver is functioning adequately, shown by specific blood test results within acceptable ranges (confirm with trial site).
• People whose kidneys are functioning adequately, based on a calculated measure of kidney filtering ability of at least 30 mL/min (confirm with trial site).
• Women who could potentially become pregnant must have a negative pregnancy blood test at screening and a negative urine pregnancy test within 24 hours before the first dose of the study drug.
• Women who could potentially become pregnant must agree to use two forms of contraception (for example, a hormonal method and a barrier method such as a condom) during the study and for 3 months after the last dose of study treatment.
• Male participants with female partners who could become pregnant must agree with their partner to use highly effective contraception during the study and for 3 months after the last dose.
• Male participants must agree not to donate sperm during the study and for 3 months after the last dose.

Who may not be able to join:

• Women who are pregnant or currently breastfeeding.
• People who currently smoke (those who stopped smoking more than one month before the screening visit may still be considered).
• People who have consumed alcohol within 72 hours before the first study drug dose, or who plan to drink alcohol during the study.
• Anyone who plans to become pregnant, father a child, or donate eggs or sperm while in the study or within 3 months after the last dose.
• People who have a known allergy or have previously had a serious reaction to the study drugs or their ingredients.
• People who are HIV-positive.
• People who test positive for hepatitis B or hepatitis C at screening.
• People who have had a serious infection requiring intravenous or systemic antibiotics within 7 days before starting the study, or who have any active infection that the study doctor considers a safety concern (for example, COVID-19).
• People who have been taking certain medications that significantly affect how the body processes drugs (specifically, moderate or strong inhibitors or inducers of certain liver enzymes) within 14 days or 5 half-lives of the medication — whichever is longer — before the first dose (confirm with trial site).
• People with a significant ongoing or historical medical condition affecting the heart, lungs, digestive system, kidneys, liver, nervous system, mental health, muscles and joints, urinary system, skin, or other body systems, if the study doctor considers it could affect participation or how the body processes the study drug.
• People who have not waited long enough after previous cancer treatments before starting the study — for example, less than 4 weeks after chemotherapy, radiation, biological therapies, targeted therapies, or major surgery (or less than 6 weeks for certain longer-acting treatments), or less than 4–6 weeks after other experimental treatments.
• People with a history of a second, different cancer, unless they have been free of that cancer for 12 or more months, or it is considered surgically cured — though certain low-risk cancers (such as some skin cancers, early-stage prostate cancer, or cancers treated with curative surgery) may still be considered eligible (confirm with trial site).
• People whose cancer has spread to the brain or spinal cord and is causing symptoms that urgently require treatment, pain management, surgery, or radiation therapy.
• People whose heart's electrical activity shows a significantly prolonged interval on an ECG (heart tracing), specifically a QTc interval greater than 480 milliseconds measured repeatedly (confirm with trial site).
• People with severe heart failure classified as New York Heart Association Class III or IV (meaning significant limitation of physical activity or symptoms even at rest).

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