Phase 2 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 were already registered to the MYELOMATCH screening programme before joining this trial, and whose blood cancer was found to have a specific gene change called an IDH2 mutation through MYELOMATCH testing, and who were then matched to this trial through the MYELOMATCH system.
• People who have been newly diagnosed with acute myeloid leukemia (AML) — a type of blood cancer — that has not yet been treated, where at least 20% of cells in the bone marrow or blood are abnormal cancer cells (excluding a specific subtype called APL with PML-RARA).
• People who are aged 60 or older; or people aged 18 or older who a doctor has determined are not suitable for a standard type of intensive chemotherapy called cytarabine-based induction therapy.
• People who have a general health and activity level rated between 0 and 3 on a standard medical scale (meaning anything from fully active to being capable of limited self-care), assessed within the 14 days before joining.
• People who have had a full medical check-up within 14 days before joining.
• People whose liver function blood test results are within acceptable ranges (tested within 14 days before joining), or who have a specific harmless liver condition called Gilbert's syndrome with results within a slightly higher acceptable range.
• People whose kidney function is adequate, with the kidneys filtering at a rate of at least 30 mL/min (tested within 14 days before joining).
• People whose heart's electrical activity, measured on a heart tracing (ECG), shows a specific reading (QTcF) below 480 milliseconds.
• People whose heart function is assessed by their treating doctor as adequate, and who — if they have a history of heart problems or treatment that affected the heart — are rated as Class 2 or better on a standard heart health scale.
• People living with HIV who are on effective HIV treatment and have had an undetectable level of the virus on their most recent test within the past 6 months.
• People with a known history of hepatitis B who have an undetectable level of the virus while on appropriate treatment, based on their most recent test within the past 6 months.
• People with a known history of hepatitis C who have been successfully treated and cured, or who are currently being treated and have an undetectable level of the virus on their most recent test within the past 6 months.
• People who are able to swallow tablets or capsules and keep them down, and who do not have a known gut condition likely to prevent oral medications from being absorbed properly.
• People who have agreed to have blood and bone marrow samples collected for research testing as part of MYELOMATCH, and who have signed an informed consent form agreeing to take part.
• People who have been offered the opportunity to have additional samples stored for possible future research (participation in this banking is optional, but the offer must be made).

Who may not be able to join:

• People who are currently receiving, or planning to receive, any other experimental treatment at the same time as this trial.
• People who have already received treatment for AML, a related blood condition called myelodysplastic syndrome (MDS), or a related condition called myeloproliferative neoplasm (MPN) — except for certain limited treatments such as hydroxyurea, a specific vitamin A-based therapy (ATRA), certain blood cell growth support medications, immune-suppressing therapy, chemotherapy injected into the fluid around the spine, a single low dose of cytarabine to reduce white blood cell counts, or a blood-filtering procedure called leukapheresis.
• People who are currently receiving cytarabine-containing therapy, unless it is a single urgent low dose (up to 1 g/m²) to reduce white blood cell counts — this must be stopped before starting trial treatment. People who have been taking hydroxyurea must also stop it before beginning treatment on this trial. White blood cell counts must be below a certain level before starting (below 25 x 10⁹/L).
• People whose heart tracing (ECG) shows a QTcF reading of 480 milliseconds or more (confirm with trial site).
• People who have another cancer — either in the past or currently — where that cancer or its treatment could affect the safety of this trial or make it harder to judge how well the trial treatment is working, in the opinion of the treating doctor.
• People who are pregnant or breastfeeding (including feeding by any method using expressed milk). People who could become pregnant or father a child must agree to use effective contraception during the trial.
• People who have another cancer whose history or treatment could interfere with the safety or results of this trial.

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