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 have given documented informed consent (or whose legal representative has done so) to take part in the study.
• People who agree to allow researchers to use stored tumour tissue from a previous biopsy (exceptions may be granted with approval from the study's lead doctor if this tissue is unavailable).
• People aged 18 years or older.
• People whose general physical functioning meets a certain minimum level, as measured by standard medical scoring tools (confirm with trial site).
• People who are scheduled to have, or have already had, a bone marrow/stem cell transplant from a donor (allogeneic transplant), regardless of the donor type or the specific transplant approach used.
• People who have been diagnosed with a blood cancer called AML, MDS, or CMML that carries a specific gene change called IDH1 mutation, identified at the time of their original diagnosis.
• People whose bone marrow check at 30 days after transplant shows the cancer is in remission, meaning fewer than 5% abnormal cells — including those who still have detectable traces of disease on sensitive tests (MRD-positive).
• People who have previously been treated with a type of drug called an IDH1 inhibitor.
• People whose blood counts and organ function fall within acceptable ranges on tests taken within 28 days before starting the trial, including: sufficient white blood cells, haemoglobin (red blood cell measure), and platelets; acceptable liver function; adequate kidney function; and a normal heart rhythm measurement (QTc interval).
• People whose blood tests within 28 days before starting the trial show they are negative for HIV, active hepatitis B, hepatitis C, and syphilis (with some additional testing required if certain results are unclear).
• Women of childbearing potential whose pregnancy test (urine or blood) is negative within 28 days before starting the trial.
• People of childbearing potential (both male and female) who agree to use an effective form of contraception or abstain from heterosexual activity throughout the study and for at least 3 months after the last dose of the study treatment.

Who may not be able to join:

• People who have had more than one donor stem cell/bone marrow transplant.
• People with a history of serious allergic reactions to medicines chemically similar to the study drug.
• People with active diarrhoea that is significant enough to interfere with taking oral medication.
• People with a significant, uncontrolled medical illness.
• People with an active, uncontrolled infection that requires treatment through the bloodstream — though people whose viral, bacterial, or fungal infections are being successfully controlled with treatment may still be considered eligible (confirm with trial site).
• People with a detectable HIV viral load in the past 6 months, or active hepatitis B or C infection.
• People with another active cancer diagnosis — although people whose previous cancer was treated with the intent to cure and who have been in full remission for more than 2 years before joining the study may still be eligible. Non-melanoma skin cancers and early-stage cervical cancer are not subject to this exclusion.
• Women who are pregnant or breastfeeding.
• People experiencing moderate to severe acute graft-versus-host disease (a complication after transplant where donor cells affect the body) requiring significant steroid treatment — though people with only mild forms of this condition managed with specific lower-level treatments may still be considered (confirm with trial site).
• People with any other medical condition that the trial doctor determines would make participation unsafe.
• People who, in the trial doctor's judgement, may not be able to follow all study procedures and requirements.

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