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:

• Adults aged 18 or older
• People diagnosed with acute myeloid leukemia (AML) that has come back or has been difficult to treat (where more than 5% of abnormal cells have returned to the bone marrow after a previous complete response) — this applies to the single-drug group
• People newly diagnosed with AML who the research team has determined are not suitable for standard treatment due to age, overall health, or other risk factors — this applies to the combination-drug group
• People diagnosed with myelodysplastic syndrome (MDS) who score in the medium, high, or very high risk categories on a standard MDS risk assessment tool called the IPSS-R (scores above 3 points)
• People whose cancer cells have a specific gene change called an IDH2 mutation
• People with a platelet count of at least 20×10⁹/L, or those with a lower platelet count that the research team determines is caused by the cancer itself
• People with liver function test results (total bilirubin) within an acceptable range — up to 1.5 times the upper limit of normal (or up to 3 times for people with a condition called Gilbert syndrome)
• People with adequate kidney function, based on blood test or urine clearance measurements (confirm with trial site for exact values)
• People who have recovered from side effects of previous surgery, radiation, or cancer treatments to a mild level or better
• People who agree to use contraception during the study and for 6 months after it ends (both women and men)
• People who voluntarily choose to take part in the study

Who may not be able to join:

• People whose AML or MDS has returned after a bone marrow transplant
• People who have received systemic cancer treatment or radiation therapy within 3 weeks before starting the trial drug
• People who have taken part in another clinical drug trial within 4 weeks before starting the trial drug
• People who have difficulty taking oral (swallowed) medication, such as those who cannot swallow, have had part of their digestive system surgically removed, have ongoing severe diarrhoea, or have a bowel blockage
• People who have previously been treated with an IDH2-targeted therapy
• People with active, uncontrolled fungal, bacterial, or viral infections
• People with high blood pressure that remains poorly controlled despite medication
• People with significant heart conditions, including moderate-to-severe heart failure, unstable chest pain in the past 3 months, reduced blood flow to the heart, certain irregular heart rhythms, or other factors that may affect heart electrical activity (confirm with trial site for full details)
• People with severe, life-threatening complications of leukemia, such as uncontrolled bleeding, low oxygen levels, shock, or a blood clotting disorder called DIC
• People with leukemia that has spread to the brain or spinal cord, or who have symptoms suggesting this
• People with a history of substance misuse involving psychotropic (mind-altering) drugs who are unable to stop, or people with a diagnosed mental disorder
• People with active hepatitis B or hepatitis C viral infections
• People with a history of immune system deficiency, including HIV-positive status, other immune deficiency conditions, or a history of organ transplantation
• People with other serious health conditions that the research team believes could put them at risk or prevent them from completing the study

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