Phase 3 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 have signed the consent form and are willing to follow the study requirements
• Adults aged 18 or older
• People whose overall physical functioning is rated as reasonably good to moderately limited (on a standard scale used by doctors, scored 0 to 2)
• People diagnosed with a type of acute myeloid leukaemia (AML) that has come back or stopped responding to treatment, and whose leukaemia has a specific gene change — either an IDH1-R132 mutation (Group 1) or an IDH2-R140 or R172 mutation (Group 2); certain subtypes of AML are excluded (confirm with trial site)
• People willing to have bone marrow samples taken before and during treatment
• People willing to complete quality-of-life questionnaires at set points during and after treatment
• Women who could become pregnant must agree to use highly effective contraception during the study and for 30 days after stopping the study drug (or 6 months if in the chemotherapy group), and must not be breastfeeding and must have a negative pregnancy test
• Men with partners who could become pregnant must agree to use condoms during the study and for 30 days after stopping the study drug (or 6 months if in the chemotherapy group), and must avoid donating or freezing sperm during this time
• People whose doctor estimates they are likely to survive for more than 12 weeks

Who may not be able to join:

• People who have previously been treated with an IDH1 or IDH2 inhibitor drug
• People known to have certain specific gene changes called RAS or FLT3 hotspot mutations (unless test results have clearly turned negative by the time of enrolment)
• People whose liver, kidney, or other organ function falls below certain levels on blood tests (confirm with trial site for specific thresholds); some exceptions apply for people with a condition called Gilbert's disease or leukaemia that has spread to the liver
• People with certain blood clotting test results outside the normal range, unless they are already on blood-thinning medication
• People with a blood enzyme called amylase that is elevated to a level the doctor considers clinically significant
• People with known liver disease, including cirrhosis, alcoholic liver disease, or active hepatitis B or C infection; people with certain hepatitis B or C markers in their blood may still be considered if specific viral load tests come back below detectable levels (confirm with trial site)
• People with a known HIV infection
• People with certain heart conditions, including serious heart rhythm problems, recent heart attack or heart surgery within the past 6 months, significant heart failure, low heart pumping function, uncontrolled high blood pressure on medication, or a specific heart electrical abnormality (long QT syndrome or QTcF measurements above set thresholds)
• People currently taking medications known to affect the heart's electrical rhythm, unless they are able to switch off them sufficiently in advance or agree to regular heart monitoring (confirm with trial site)
• People who have had another cancer in the past 5 years, with some exceptions for certain fully treated, non-invasive skin or cervical cancers, and breast cancer in situ
• Women who are pregnant or breastfeeding
• People who still wish to have children (confirm with trial site)
• People who have had a stroke or bleeding in the brain within the past 6 months
• People who have had major surgery within the past 4 weeks
• People who have received certain antibody-based cancer treatments within approximately the past 3 weeks or longer (depending on the specific drug's half-life)
• People who have taken part in another clinical trial involving an experimental treatment within the past 3 weeks
• People who have received chemotherapy, targeted therapy, immunotherapy, or anti-cancer vaccines within the past 3 weeks; radiotherapy within the past 3 months; CAR-T cell therapy within the past 4 weeks; or a stem cell transplant within the past 60 days — or who are still receiving anti-rejection therapy or have active graft-versus-host disease requiring medication after a transplant (some limited exceptions may apply — confirm with trial site)
• People with leukaemia that has spread to the central nervous system (brain and spinal cord)
• People who have received a live vaccine within the past 4 weeks
• People who have used traditional Chinese herbal medicines with anti-cancer effects within the past week
• People with an active, uncontrolled infection (fungal, bacterial, or viral) that has not improved with treatment, or who have had an unexplained persistent fever above 38.5°C during the screening period (unless the doctor determines it is caused by the leukaemia itself)
• People who are unable to swallow tablets or capsules, or who have serious stomach or bowel conditions that could affect how the body absorbs the study drug
• People who have side effects from previous cancer treatment that have not yet recovered to a mild level (hair loss is excluded from this requirement)
• People with any other significant medical condition, abnormal test result, or other concern that the doctor believes makes participation unsuitable or could make the results difficult to interpret

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