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 aged 18 or older who have given written consent to participate.
• People whose general physical functioning is rated at a moderate level or better on a standard oncology scale (ECOG score of 2 or less).
• People with a life expectancy of more than 3 months.
• People who have been diagnosed with acute myeloid leukemia (AML) confirmed by tissue testing, where the disease has come back or has not responded to treatment.
• People whose AML has returned and who have already tried at least one further treatment after relapse, OR whose AML has returned but they are not suitable for a bone marrow/stem cell transplant from a donor.
• People with newly diagnosed AML that has not gone into remission after two rounds of treatment, OR whose AML did not respond to initial treatment and who are not suitable for a donor stem cell transplant.
• People whose AML developed from a prior blood disorder (MDS or a myeloproliferative condition) and whose disease did not respond to standard treatments for those conditions.
• People who have relapsed after receiving a donor stem cell transplant, provided it has been at least 3 months since the transplant, there is no active graft-versus-host disease, and they are not on immune-suppressing medicines (except a low dose of steroids).
• People whose white blood cell count is at or below a certain level before starting venetoclax treatment (a medication used in this trial); a medication called hydroxyurea may be used beforehand to bring this count down if needed.
• People whose liver function blood test results (bilirubin, AST, and ALT) are within acceptable ranges, with an exception for those with a specific inherited condition called Gilbert's disease.
• People whose kidneys are functioning at an adequate level, measured by a standard test.
• People whose heart's electrical activity (a measurement called QTc) is within a safe range on an ECG.
• Women who could become pregnant must have a negative pregnancy test before joining.
• People of childbearing potential must agree to use effective contraception or avoid heterosexual activity during the study and for at least 6 months after the last dose (for women) or 3 months (for men).
• Male participants must agree not to donate sperm during the study and for at least 90 days after the last dose.

Who may not be able to join:

• People currently using or planning to use other experimental treatments, cancer treatments, chemotherapy, or radiation therapy during the study, or within 2 weeks before starting the trial (hydroxyurea is an exception and may continue through the first treatment cycle).
• People expected to receive a donor stem cell transplant within 120 days of joining the trial.
• People currently using or planning to use medications known or suspected to affect a specific heart rhythm measurement (QTc interval).
• People who have taken certain medications that interact with a liver enzyme called CYP3A (strong or moderate inducers, or St. John's Wort) within 7 days before starting the trial.
• People who have taken certain other CYP3A-interacting medications (strong or moderate inhibitors) or consumed grapefruit, grapefruit products, Seville oranges (including marmalade), or star fruit within 3 days before starting the trial.
• People who have taken certain other medications that affect drug transport in the body (P-glycoprotein inhibitors or certain substrates) within 7 days before starting the trial.
• People with a specific type of leukemia called acute promyelocytic leukemia (APL).
• People with leukemia that has spread to the brain or spinal fluid (active CNS leukemia).
• People with an active serious fungal infection or blood poisoning (bacterial sepsis).
• People with severe heart failure classified as Class III or IV by standard medical criteria.
• People with significant heart rhythm problems that have not been stable with treatment within the two weeks before joining (people with controlled, symptom-free atrial fibrillation may still be considered).
• People who have had a heart attack or unstable chest pain (unstable angina) within the 6 months before joining.
• People with a history of unexplained fainting, significant coronary artery disease requiring surgical or catheter-based procedures, or a weakened heart muscle (with pumping function below 50%).
• People who have had surgery or have a digestive condition that could affect how the body absorbs medications (for example, gastric bypass, stomach removal, or conditions causing poor nutrient absorption).
• People who are unable to swallow capsules, have a bowel obstruction, or have a digestive condition that causes poor absorption.
• People with an active peptic (stomach) ulcer.
• People with another active cancer, except for certain early-stage or localised cancers (such as skin cancer, or early-stage bladder, prostate, breast, or cervical cancer that has not spread).
• Women who are pregnant or breastfeeding.
• People with any other medical condition that the trial doctor believes would make participation unsafe.
• People who, in the trial doctor's opinion, may not be able to follow all study procedures and requirements.

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