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 Leukemia (AML) that has come back or stopped responding to at least one standard treatment.
• People aged 18 or older.
• People who are well enough to carry out basic daily activities, based on a standard medical scale that measures physical ability (ECOG score of 0, 1, or 2 — confirm with trial site).
• People whose liver function blood tests are within an acceptable range, with a specific exception allowed for a condition called Gilbert's syndrome (confirm with trial site).
• People whose kidney function is above a certain level, based on a blood test.
• People whose hemoglobin (a measure of red blood cells) is above a certain level — a blood transfusion beforehand is allowed to reach this level.
• People whose white blood cell count is below a certain level at the start of treatment — a medication called hydroxyurea may be used to help reach this level during the first cycle.
• People whose platelet count is above a certain level at the start of treatment — a transfusion beforehand is allowed to reach this level.
• People with suitable veins to allow for regular blood tests throughout the study.
• People whose doctor estimates they are likely to live long enough to receive at least 3 months of treatment.
• People who are willing to sign a consent form and understand they may withdraw from the study at any time without it affecting their future care.
• Women who are either past menopause, have had surgery that prevents pregnancy, or agree to use two effective forms of contraception (or remain completely abstinent) from the time of signing consent until 4 months after the last dose of study treatment.
• Men, including those who have had a vasectomy, who agree to use effective barrier contraception (or remain completely abstinent) throughout treatment and for 4 months after the last dose.
• People who are willing to have bone marrow tests and blood samples taken at specific points throughout the study.

Who may not be able to join:

• People who have taken certain medications that affect how the body processes drugs (enzyme inducers) within 14 days before starting the study treatment.
• People diagnosed with a specific subtype of leukemia called acute promyelocytic leukemia (APL).
• People who have received any other experimental treatment, cancer treatment, or radiation therapy within 14 days before starting the study (an exception applies for hydroxyurea — confirm with trial site).
• People who are eligible for, and willing to have, standard treatments that could potentially cure their condition.
• People who have had major surgery within 14 days before starting the study, or who have surgery planned during the study period.
• People who have significant diarrhea that has not been controlled with appropriate supportive medications in the 7 days before starting treatment.
• People with certain serious heart or lung conditions, including very high uncontrolled blood pressure, certain forms of heart disease, moderate-to-severe heart failure, significant heart valve problems, or certain serious lung conditions such as moderate-to-severe COPD, interstitial lung disease, or pulmonary fibrosis (some exceptions may apply — confirm with trial site).
• People with an active, uncontrolled serious infection such as severe pneumonia, meningitis, or blood poisoning.
• People with HIV that is not under control (detectable viral load).
• People who test positive for hepatitis B surface antigen, unless specific additional conditions are met (confirm with trial site).
• People with active hepatitis C infection, unless the viral load is undetectable (confirm with trial site).
• Women of childbearing potential who are unwilling to use two effective forms of contraception or abstain from sex for the required period.
• Sexually active men who are unwilling to use effective barrier contraception during and for 4 months after treatment, including those who have had a vasectomy.
• Women who are pregnant, breastfeeding, or have a positive pregnancy test at the start of the study.
• Women who plan to donate eggs during the study or within 4 months of the last dose.
• Men who plan to donate sperm during the study or within 4 months of the last dose.
• People with a serious medical or mental health condition that, in the doctor's opinion, could interfere with completing the study.
• People with symptoms of leukemia affecting the brain or nervous system.
• People who have been diagnosed with or treated for another cancer within the past 2 years, or who still show signs of a previous cancer (an exception applies for certain skin cancers or non-spreading tumours that have been fully removed — confirm with trial site).
• People with serious liver scarring (cirrhosis) or severe liver disease.
• People currently taking, or expected to need, certain medications that are not permitted during the study (confirm with trial site).
• People with an uncontrolled blood clotting or bleeding disorder.
• People with a life-threatening illness unrelated to their cancer.
• People who are not able to make their own informed decisions about participation.

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