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 are able to give informed consent to participate.
• People aged 18 or older at the time of giving consent.
• People who have a confirmed diagnosis of either: acute myeloid leukaemia (AML) that has come back or stopped responding to treatment, or high-risk or very-high-risk myelodysplastic syndrome (MDS) as classified by recognised medical scoring systems.
• People whose general health and ability to carry out daily activities meets the study's required level (a score of 0 or 1 on a standard medical scale used in cancer trials).
• People who agree to have regular blood and bone marrow samples taken during the study.
• People who have finished any standard (non-experimental) cancer treatments at least 14 days before starting the study drug. A medication called hydroxyurea may be allowed for a limited time around the start of the study drug (confirm with trial site).
• People whose side effects from previous treatments have settled down or are mild.
• People who are able to swallow and keep down tablets or capsules.
• People whose blood oxygen levels meet the study's minimum requirements, with little or no breathing difficulty.
• People who can have a negative pregnancy blood test result before starting the study.
• People who are capable of becoming pregnant and agree to use effective contraception and not donate eggs from the start of screening until 6 months after stopping the study drug. This requirement does not apply to people who have had surgical sterilisation or who have been through menopause for 2 or more years.
• Men who agree to use effective contraception and not donate sperm from the start of the study drug until 6 months after stopping it.
• People whose organ function and blood test results meet the study's required levels (confirm specific values with trial site).

Who may not be able to join:

• People who have leukaemia that has spread to the brain or spinal cord.
• People who have had a stem cell transplant within the last 60 days, are still on medication to suppress the immune system after a transplant, or have graft-versus-host disease requiring treatment taken by mouth or injection (a skin cream for skin-only graft-versus-host disease may be allowed).
• People who have severe, life-threatening complications from leukaemia, such as uncontrolled bleeding, serious lung infection, blood poisoning, or a serious blood clotting disorder.
• People who have a known allergy or medical reason not to take the study drug or closely related medicines.
• People with a significant active infection. People with a simple urinary tract infection or straightforward throat infection being treated successfully may still be considered. People who have received antibiotic injections or drips within 7 days before joining are not eligible (preventive antifungal, antiviral, or antibiotic medicines may be allowed).
• People with an active HIV infection.
• People with an active hepatitis B or hepatitis C infection.
• People with a primary immune system deficiency condition.
• People who need daily steroid medication (such as prednisone) at a dose of 10 mg or more per day. People using steroid creams or inhalers that are not absorbed significantly into the body may still be considered.
• People who have received a live vaccine within 6 weeks before starting the study drug.
• People taking certain medicines that strongly affect how the body processes drugs, specifically strong CYP3A inhibitors (except certain antifungal medicines) or CYP3A inducers (confirm specific medicines with trial site).
• People who have taken medicines that reduce stomach acid, such as certain heartburn or reflux treatments (for example, ranitidine, famotidine, omeprazole, or esomeprazole), within 7 days before starting the study drug or during the study.
• People who are currently pregnant, planning to become pregnant during the study, or who are breastfeeding.
• People who have difficulty swallowing or conditions that affect how the body absorbs medicines taken by mouth.
• People currently taking certain prohibited medicines within 1 week before starting the study drug (confirm specific medicines with trial site).
• People with clinically significant heart or blood vessel disease (confirm specific conditions with trial site).
• People who have had major surgery within 4 weeks before joining the study.
• People who have had an organ transplant and need ongoing immune-suppressing medication.
• People with a history of, or current, autoimmune disease that requires ongoing treatment, such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, or lupus.
• People who have had radiation therapy within 7 days before starting the study drug.
• People who have had another cancer diagnosed within the last 2 years, except for certain cancers that have been fully and successfully treated, such as some skin cancers, early-stage breast or prostate conditions, or cervical carcinoma in situ.
• People who are currently taking part in another experimental treatment study, or who have done so within 3 weeks before joining.
• People who are unwilling or unable to follow the study's requirements.
• People who have any other condition that the study doctor believes could interfere with the study results or the person's safety.

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