Phase 1 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 acute myeloid leukaemia (AML) that has come back or stopped responding to treatment, confirmed using 2022 medical guidelines.
• Depending on the phase and group, people who have already tried standard treatments that did not work — this includes having tried intensive chemotherapy, or a combination of certain lower-intensity treatments (such as HMA/venetoclax or HMA alone), as well as any other approved treatments relevant to their specific disease type (such as targeted therapies for certain gene mutations).
• Adults aged 18 years or older.
• People who are reasonably well and able to carry out daily activities, based on a standard medical scoring scale (a score of 0, 1, or 2 out of 4).
• People whose side effects from any previous cancer treatment have mostly cleared up (reduced to a mild level or gone entirely), not counting hair loss.
• People whose heart, liver, kidneys, and other organs are functioning well enough as determined by the trial site.
• People who are able to swallow capsules whole, without chewing, crushing, or opening them.
• People who are willing and able to attend scheduled visits, follow the treatment plan, and complete required tests and procedures.
• People who have waited at least 2 weeks or 5 half-lives (whichever is longer) since their last cancer treatment before starting the trial, except for a specific drug called hydroxyurea.
• People who agree to use highly effective contraception or remain completely abstinent during the trial and for a set period after treatment ends — 210 days for women who could become pregnant, and 120 days for men (who must also avoid donating sperm during this time). Note: because the study drug may reduce how well hormonal contraceptives work, women who could become pregnant must use a non-hormonal form of contraception.
• People who have read, understood, and signed an informed consent form approved by an ethics committee, showing they understand the nature of the trial, the procedures involved, and the potential risks and benefits.

Who may not be able to join:

• People who are currently taking part in another interventional clinical trial (unless they are only being followed up for survival in that other trial).
• People with a very high white blood cell count (above 20,000 per microlitre), unless it can be brought down to an acceptable level with hydroxyurea or a blood-filtering procedure called leukapheresis before treatment starts.
• People diagnosed with a specific type of leukaemia called acute promyelocytic leukaemia, or a type linked to a genetic change called BCR-ABL-positive leukaemia.
• People who currently have another active cancer, with some exceptions for certain minor skin cancers, a specific type of cervical finding treated with a cone biopsy, or certain superficial bladder cancers.
• People whose leukaemia has spread to the brain or spinal cord.
• People who have had a stem cell transplant within the 3 months before the trial starts, or who still have significant side effects (grade 2 or higher) from a previous transplant.
• People who have active graft-versus-host disease (a complication from a transplant where donor cells attack the body) that requires medication to suppress the immune system.
• People with a specific type of heart rhythm abnormality (QTcF interval of 470 milliseconds or more), or certain heart-related risk factors such as uncontrolled heart failure, low potassium levels, or a personal or family history of certain heart rhythm conditions.
• People who are pregnant. Women who could become pregnant must have a negative pregnancy test before starting the trial.
• People who are breastfeeding or planning to breastfeed during the trial or within 90 days after treatment ends.
• People with known active digestive conditions (such as stomach ulcers, Crohn's disease, ulcerative colitis, or other conditions that affect how the body absorbs medication).
• People taking certain antacid medications — proton pump inhibitors are not permitted at all; calcium carbonate antacids are only allowed at specific times around dosing (confirm with trial site).
• People taking certain other medications that strongly affect how the body processes the study drug (specific drug interaction types involving enzymes called CYP3A4, CYP2C9, CYP2D6, CYP1A2, CYP2B6, and a transporter called P-gp), unless those medications can be safely switched to an alternative (confirm with trial site).
• People who have had major surgery within 4 weeks before the trial starts.
• People who have had radiotherapy within 4 weeks before the trial starts, unless the area treated was very small (covering 5% or less of the bone marrow).
• People who have had a severe episode of pancreatitis (inflammation of the pancreas) requiring medical treatment or hospitalisation in the 6 months before the trial starts.

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