Phase 1 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 willing and able to read, understand, and sign a written consent form before any study procedures begin.
• People who are 18 years of age or older at the time of signing the consent form.
• People who have a confirmed diagnosis of a myeloid blood cancer that has come back, stopped responding to treatment, or could not be tolerated — including polycythemia vera (PV), essential thrombocythemia (ET), primary myelofibrosis (PMF), myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), or myelofibrosis that developed from PV or ET — diagnosed according to specific medical classification systems.
• People whose general physical functioning is rated at a level of 0, 1, or 2 on a standard medical scale (meaning they are fully active, have some limits on heavy activity, or are up and about but unable to do much work).
• People whose life expectancy is greater than 3 months.
• People whose heart, liver, kidneys, blood counts, and clotting function are working well enough as determined by standard tests.
• People who are willing and able to attend all required study visits and follow the study's requirements.

Who may not be able to join:

• People diagnosed with a specific type of leukemia called acute promyelocytic leukemia (APL).
• People who have received certain cancer treatments too recently before the first dose of the study drug — the required waiting periods vary depending on the type of blood cancer and the type of treatment received (confirm with trial site for the specific timeframe that applies).
• People who have taken another experimental drug within 28 days, or within 5 half-lives of that drug (whichever is shorter), before the first dose of the study drug.
• People who still have unresolved side effects (rated Grade 1 or higher) from previous cancer treatments that have not returned to their pre-treatment baseline, except for hair loss or skin darkening.
• People who are expected to receive other cancer treatments or experimental drugs during the study period.
• People who have active graft versus host disease (a condition that can occur after a stem cell transplant) that requires ongoing medication to suppress the immune system.
• People who received an autologous stem cell transplant within the last 3 months, or an allogeneic (donor) stem cell transplant within the last 6 months, before the first dose of the study drug.
• People whose cancer has spread to the brain or spinal cord and is currently active.
• People who have moderate or severe nerve damage in their hands or feet (rated Grade 2 or higher on a standard medical scale).
• People who have had a different type of cancer in the past 5 years, except for certain types that were fully removed or treated, such as some skin cancers, early-stage cervical cancer, or early-stage prostate cancer.
• People whose heart's electrical activity shows a prolonged QT interval (greater than 450 milliseconds) on an ECG test at screening.
• People who currently have, or have had within the last 6 months, significant heart problems or reduced heart function.
• People with a currently active hepatitis B or hepatitis C infection.
• People who are known to have HIV.
• People with a serious, life-threatening active infection unrelated to their blood cancer that is not under control.
• People who have a medical condition that the treating doctor believes may affect how the study drug is absorbed, processed, or removed by the body.
• People who have taken certain medications or supplements — known as strong or moderate inhibitors or inducers of specific liver enzymes (CYP3A, P-gp, or CYP2C8) — within 7 days or 5 half-lives before the first dose of the study drug (confirm with trial site for specific medications).
• People who have had major surgery within 28 days before the first dose of the study drug, or who have not yet recovered from a recent surgery.
• People who are pregnant or currently breastfeeding.
• People who have a cognitive impairment due to a psychiatric or neurological condition — such as epilepsy or dementia — that may limit their ability to understand or comply with the study requirements.
• People who the treating doctor considers unsuitable for the study for any other reason.

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