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 18 years of age or older at the time of signing the consent form.
• People who are willing and able to attend study visits and follow the study requirements.
• People who have AML (a type of blood cancer) that has come back after treatment or did not respond to treatment, or who have MDS (a bone marrow condition) that has come back or did not respond to treatment.
• People who have other health conditions that, in the doctor's judgment, make intensive chemotherapy unsuitable for them.
• People with MDS must have a specific classification (MDS-IB1 or IB2 according to 2022 WHO guidelines) — confirm with trial site if unsure.
• People who have a specific genetic change called TP53Y220C, confirmed by an approved laboratory test, present in more than 2% of tested cells.
• People whose general health and ability to carry out daily activities meets a standard rating of 2 or below on a medical scale (meaning able to care for oneself but may not be able to do heavy physical work).
• People whose liver is functioning well enough — based on blood test results for liver enzymes and bilirubin within acceptable ranges (unless any abnormality is caused by the blood cancer itself or a specific known condition).
• People whose kidneys are functioning well enough — based on blood test results for creatinine or a kidney function calculation within acceptable ranges.
• Women who could become pregnant must have a negative pregnancy test before starting the study and within 72 hours of the first dose, and must agree to use two highly effective forms of contraception during the study and for 3 months after the last dose, or abstain from sexual intercourse during that time.
• All women between the start of menstrual periods and age 55 (unless they meet specific exemptions such as menopause, surgical removal of the uterus or ovaries, tubal ligation, or confirmed ovarian failure) must agree to use approved contraception starting 14 days before joining the study and throughout participation.
• Men enrolled in the study must also agree to use adequate contraception before, during, and for 3 months after completing the study treatment.
• People who are able to understand the study and are willing to sign a written consent form.

Who may not be able to join:

• People who have received chemotherapy, targeted therapy, immunotherapy, or another experimental cancer treatment within 14 days (or within 5 half-lives of the drug, whichever is shorter) before the first study dose.
• People who have received radiation therapy within the past 14 days.
• People who have a specific type of leukemia called acute promyelocytic leukemia (APL).
• People who have immediately life-threatening complications from leukemia, such as uncontrolled bleeding, pneumonia with low oxygen levels or shock, or a serious blood-clotting disorder.
• People who have active, uncontrolled leukemia that has spread to the brain or spinal cord.
• People who have an active HIV infection, or active hepatitis B or hepatitis C infection.
• People who have difficulty swallowing, problems absorbing food or medication through the gut, or other conditions that would prevent them from taking oral (swallowed) medications properly.
• People who have an active, uncontrolled infection (fungal, bacterial, or viral) that is not improving despite appropriate treatment.
• People who still have side effects from previous cancer treatment that are above a mild level (Grade 1), except for hair loss or certain nerve-related symptoms from prior chemotherapy (Grade 2 neuropathy is allowed).
• People who have had major surgery within 2 weeks before the planned start of the study treatment.
• People who are pregnant or currently breastfeeding.
• People who have had a serious allergic reaction to azacitidine, rezetapopt, or similar compounds used in this study.

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