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 18 years of age or older.
• People who have been diagnosed with an advanced blood cancer that has a specific genetic change called an IDH1 R132 mutation, confirmed by laboratory testing.
• People who are willing to provide repeated bone marrow, blood, and urine samples throughout the study.
• People who are reasonably active and able to carry out daily activities, based on a standard health performance scale (rated 0 to 2 out of 4).
• People who have a platelet count of at least 20,000 per microlitre (blood transfusions to reach this level are permitted).
• People whose liver is functioning adequately, as shown by certain blood test results being within acceptable ranges (unless any abnormality is caused by the blood cancer itself or a specific inherited condition).
• People whose kidneys are functioning adequately, as shown by specific blood or urine measurements being within acceptable ranges.
• People who have recovered from any significant side effects of previous cancer treatments, such as surgery, radiation, or other therapies.
• Women who are capable of becoming pregnant must have a negative pregnancy blood test within 7 days before starting the study drug, and again on the first day of taking it.

Who may not be able to join:

• People who have had a stem cell transplant within the past 60 days, or who are currently taking immune-suppressing medicines after a transplant, or who have significant complications from a transplant (known as graft-versus-host disease). Note: a stable dose of steroids taken by mouth or applied to the skin for mild transplant-related skin reactions may still be permitted (confirm with trial site).
• People who have received chemotherapy or radiation therapy within the 14 days before starting the study drug.
• People who have taken part in another clinical trial and received an experimental treatment within the 14 days before starting the study drug.
• People who are currently pregnant or breastfeeding.
• People who have a serious active infection, or who have an unexplained fever above 38.5°C at the time of screening or on the first day of the study drug (exceptions may apply for fevers caused by the cancer itself, at the doctor's discretion).
• People with serious heart failure classified as Stage III or IV (a medical classification of severe heart symptoms), or whose heart pumping function is below 40% as measured by a heart scan within approximately 28 days of starting the study.
• People who have had a heart attack within the 6 months before screening.
• People with chest pain caused by unstable or uncontrolled heart disease (angina).
• People with a known history of serious or uncontrolled abnormal heart rhythms.
• People who have a specific measurement of heart electrical activity (called the QTc interval) at 450 milliseconds or above, or other factors that raise the risk of heart rhythm problems.
• People who are taking medications known to affect heart rhythm in a way that could be dangerous.
• People with a known diagnosis of HIV, or active hepatitis B or C infection.
• People who have signs or a confirmed diagnosis of leukemia that has spread to the brain or spinal fluid.
• People experiencing immediately life-threatening complications from their leukemia, such as uncontrolled bleeding, severe pneumonia with low oxygen levels, shock, or a serious blood-clotting disorder.

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