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 been newly diagnosed with a type of blood cancer called AML or MDS/AML that has a specific genetic change called an IDH1 mutation (including cases where both IDH1 and IDH2 mutations are present), confirmed by a central laboratory.
• People aged 18 or older — there is no upper age limit.
• People whose doctors have determined they are not suitable for standard intensive chemotherapy, either because they are 75 or older and their doctor has judged them unfit, or because they are aged 18–74 and have at least one of the following health conditions: a functional status score of 2 or 3 on a standard medical scale; certain heart conditions such as heart failure, low heart pump function, or stable angina; reduced lung function on specific breathing tests; kidney function within a certain reduced range; moderately impaired liver function; or another health condition that the treating doctor considers incompatible with intensive chemotherapy.
• People whose doctor estimates they are expected to live for at least 12 weeks.
• People whose white blood cell count is below a certain level at the time of joining (a medication called hydroxyurea may be used beforehand to bring this count down if needed).
• People with kidney function above a minimum threshold, as measured by a standard formula.
• People with liver function results within acceptable ranges (certain exceptions may apply — confirm with trial site).
• Women who are not able to become pregnant, either because of menopause (at least one year without a period) or because they have had a surgical procedure such as removal of the uterus or ovaries.
• Women who could potentially become pregnant but agree to avoid pregnancy during the study and for 6 months after the last dose, test negative for pregnancy at the start, use a highly effective method of birth control combined with a barrier method throughout the study and for 6 months after the last dose, do not breastfeed from the start of the study until 1 month after the last dose, and do not donate eggs during the study or for 6 months after the last dose.
• Men who agree to use a latex condom during any sexual contact with women who could become pregnant throughout the study and for 6 months after the last dose (even if they have had a vasectomy), whose female partners who could become pregnant also use a highly effective method of birth control, and who agree not to donate sperm from the start of the study until 6 months after the last dose.
• People who are able to understand and willing to sign a consent form agreeing to take part in the study.

Who may not be able to join:

• People who have previously received treatment for AML (prior use of hydroxyurea to control white blood cell counts is permitted; prior use of certain medications for a related condition called MDS-EB is not permitted).
• People with a specific subtype of blood cancer called acute promyelocytic leukaemia (APL) involving certain known genetic changes.
• People with a type of leukaemia involving a genetic change called BCR-ABL1, or whose chronic myeloid leukaemia (CML) has progressed to a blast crisis.
• People who have had serious active heart problems in the 3 months before the study starts, including severe heart failure, a heart attack, unstable chest pain, serious heart rhythm problems, a condition called congenital long QT syndrome (or a family member with this condition), or an abnormal heart electrical reading above a certain level.
• People with a family history of sudden death or a serious heart rhythm disorder called polymorphic ventricular arrhythmia.
• People with a severe breathing disorder affecting airflow in or out of the lungs.
• People who have had a stroke or bleeding in the brain within 6 months before joining the trial.
• People with signs or symptoms suggesting leukaemia has spread to the brain or spinal fluid, or who are known to have this.
• People with an active, uncontrolled infection — including hepatitis B, hepatitis C, or HIV — that could interfere with the study or put the person at undue risk (certain controlled infections may be allowed — confirm with trial site); people with active COVID-19 symptoms or who have not tested negative twice by a specific test.
• People experiencing life-threatening complications of leukaemia such as uncontrolled bleeding or a serious clotting disorder.
• People who have difficulty swallowing or absorbing oral medications due to a digestive condition.
• People who currently have another active cancer, unless their doctor considers the risk of that cancer returning within one year to be below 30%; certain low-risk skin cancers, early-stage cervical or breast changes, or an incidental finding of prostate cancer may be allowed (confirm with trial site).
• People who have received a live vaccine within 30 days before joining the trial.
• People with a severe neurological or psychiatric condition that would prevent them from being able to give informed consent.
• People who have a medical reason they cannot take one of the anti-leukaemia medications used in the trial.
• People already taking part in another prospective study involving anti-leukaemia or experimental treatments.
• People taking a blood-thinning medication called Dabigatran, unless they are able to switch to a different medication at least 5 half-lives before starting the trial (confirm with trial site); people taking certain other medications that interact with the study drugs may also need to be monitored or switched (confirm with trial site).
• People taking certain medications known to strongly affect how the body processes the study drug, unless they are able to switch to a different medication at least 5 half-lives before starting.
• People who are pregnant, breastfeeding, or planning to become pregnant during the study.
• People who have previously been enrolled in this same trial and were found to be ineligible — re-entry into the trial is not permitted.

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