Phase 2 Leukaemia Trial, Recruiting

Written by an AI model from the 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 diagnosed with CCUS (a condition involving low blood cell counts that are unexplained and not caused by a blood cancer) or a lower-risk form of MDS or CMML (types of bone marrow disorders), confirmed by laboratory testing and scoring systems used by doctors to assess risk level.
• People who have a specific gene mutation called IDH1, detected at a certain level in their blood or bone marrow (variant allele frequency of at least 0.02).
• People who are 18 years of age or older.
• People whose general physical functioning falls within an acceptable range on a standard scale used by doctors to measure how well a person can carry out daily activities (ECOG score of 0 to 2 — confirm with trial site).
• People whose liver is working within acceptable levels, based on standard blood tests measuring liver enzymes and bilirubin (with slightly higher limits allowed for people with a condition called Gilbert Syndrome).
• People whose kidneys are working within an acceptable range, based on blood tests or a calculated measure of kidney filtering ability.
• Women who could become pregnant must have a negative pregnancy test before joining.
• People who are able and willing to use highly effective contraception (such as hormonal birth control, an intrauterine device, or a condom combined with spermicide) throughout the trial and for 90 days after the last dose of the study medication.
• Male participants must agree not to donate sperm, and female participants who could become pregnant must agree not to donate eggs, during the trial and for 90 days after the final dose.
• People who are able and willing to give written informed consent before the trial begins.

Who may not be able to join:

• People who are unable to swallow tablets or capsules, or who have a digestive condition that a doctor believes would stop the body from properly absorbing the study medication (such as malabsorption or prior surgical removal of part of the gut).
• People who have another serious or uncontrolled medical condition — including a life-threatening infection or a significant mental health condition — that a doctor believes would put them at too much risk from the study treatment.
• People with a known active hepatitis B, hepatitis C, or HIV infection.
• Women who are pregnant or breastfeeding, or women who could become pregnant but are not using highly effective contraception, as well as male participants not using highly effective contraception as described in the joining criteria.
• People whose white blood cell count is too high (above 25 x10⁹/L) — note that a medication called hydroxyurea may be used to lower this count before joining, with no waiting period required (confirm with trial site).
• People who are unwilling or unable to follow the procedures required by the trial or considered part of standard medical care.

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