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
• People who are willing to sign a consent form (or have a legal representative do so on their behalf), including non-English speakers for whom interpreter support is available
• People who are willing to allow the use of stored tumour tissue from a previous biopsy (exceptions may be possible with approval from the lead researcher)
• People whose general health and ability to function meets a minimum score on a standard medical scale called the Karnofsky Performance Scale (score of 70 or above) (confirm with trial site)
• People with a life expectancy of at least 16 weeks at the time of joining
• People who have a confirmed diagnosis of active AML (a type of blood cancer) that carries a specific protein called CD33, whether it developed on its own or from another condition, or people considered at high risk of the disease coming back
• People whose AML has come back after initially responding to treatment, or whose AML has not responded to standard chemotherapy
• People who have bone marrow and/or blood samples available to confirm the AML diagnosis and CD33 status, tested within 90 days of joining the trial
• People whose liver function blood test results fall within acceptable ranges (bilirubin no higher than 2.0 mg/dL, or up to 3.0 mg/dL for those with a condition called Gilbert syndrome; liver enzyme levels no more than 3 times the upper limit of normal)
• People whose kidneys are functioning adequately, based on a standard calculation, and who are not on dialysis
• People whose heart pumping function is at least 50%, measured within the 8 weeks before joining
• People whose blood oxygen level is above 92% without needing supplemental oxygen
• People who test negative for pregnancy (if applicable)
• People who are willing to use effective contraception or abstain from heterosexual activity during the study and for at least 6 months after the last treatment dose (applies to people who could potentially father or become pregnant)
• People who have an identified donor or stem cell source available for a bone marrow transplant
• People who had a previous bone marrow transplant more than 6 months before joining the trial
• People whose identified donor is HIV negative, meets the same general health score requirement, and has their body weight documented

Who may not be able to join:

• People who had a previous bone marrow transplant less than 6 months before joining
• People currently using systemic (whole-body) steroids or regular immunosuppressant medications, unless these have been stopped at least 28 days before joining (routine inhaled or topical steroids at standard doses, or very low-dose steroid replacement therapy, may be acceptable)
• People with an active autoimmune disease, including graft versus host disease, that requires immune-suppressing treatment, unless that treatment has been stopped at least 28 days before joining
• People currently receiving other experimental treatments, or who depend on other biological therapies, chemotherapy, or radiation therapy (a medication called Hydrea must be stopped before a specific stage of the trial)
• People who have been receiving active treatment for a fungal infection within 8 weeks of joining (people taking antifungal medication as a preventive measure may still be eligible)
• People who have significant scarring in the bone marrow, rated at Grade 2 or above on a standard scale
• People with significant heart rhythm problems that are not stable with medication within two weeks of a procedure called leukapheresis (people with well-controlled atrial arrhythmia may still be eligible)
• People with known bleeding disorders such as von Willebrand's disease or haemophilia
• People who have had a stroke or bleeding in the brain within the 6 months before screening
• People with another currently active cancer (people who have previously had cancer that was fully treated and is in complete remission may still be eligible)
• People with a serious uncontrolled medical condition
• People with an active infection currently being treated with antibiotics
• People who have tested positive for HIV, or who have active hepatitis B or C infection, based on testing within 4 weeks of joining
• People with an active viral hepatitis infection
• People who are pregnant or breastfeeding
• People whose circumstances or health, in the judgement of the study doctor, would make participation unsafe or not feasible

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