Early 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 have been diagnosed with a type of blood cancer called Acute Myeloid Leukemia (AML), confirmed by laboratory testing, where the cancer cells test positive for a protein called CD117.
• The AML diagnosis must meet specific international classification standards and be considered either "relapsed" (the cancer came back after a period of remission) or "refractory" (the cancer did not respond well enough to standard treatments), with no other suitable standard treatments or registered trials available.
• Relapsed AML is defined as leukemia cells reappearing in the blood or bone marrow (more than 5% abnormal cells by microscope examination, or more than 1% by a more detailed cell analysis called flow cytometry), or leukemia appearing outside the bone marrow, after the cancer had previously gone into full remission.
• Refractory AML applies to people meeting at least one of the following: the cancer did not reach full remission after two rounds of standard initial treatment; the cancer returned within 12 months of remission after follow-up treatment; the cancer returned after 12 months but did not respond to further chemotherapy; the cancer has relapsed two or more times; or leukemia is present outside the bone marrow and is not responding to treatment.
• Liver function blood test results must be within acceptable ranges — specifically, bilirubin no more than 1.5 times the upper limit of normal, and liver enzymes (ALT and AST) no more than 3 times the upper limit of normal.
• Kidney function must be within an acceptable range, with a blood creatinine level no more than 1.5 times the upper limit of normal.
• The heart must be pumping adequately, with a heart pumping strength (called ejection fraction) of at least 50%, confirmed by an ultrasound of the heart.
• Blood oxygen levels must be at least 92% when breathing normal room air.
• A life expectancy of at least 3 months, as assessed by the treating doctor.
• A general health and activity level rated as 0, 1, or 2 on a standard medical scale (meaning the person is fully active, has some limitations but can care for themselves, or is up and about more than half of waking hours).
• People who could become pregnant must agree to use highly effective contraception from the start of the study, throughout treatment, and for at least 6 months after receiving the cell treatment.
• Willingness to take part voluntarily, understanding of the study process, and signing of a written consent form (which can be done by a legally authorised representative if needed).

Who may not be able to join:

• People with a history of epilepsy or other diseases of the brain or nervous system.
• People with a prolonged QT interval (an abnormality seen on a heart tracing) or other serious heart disease.
• People with an active infection that has not been successfully treated.
• People with an active hepatitis B or hepatitis C infection.
• People who have previously received any gene therapy product.
• People whose cells do not respond adequately to a specific laboratory growth test (proliferating less than 5 times in response to a standard stimulation signal) — (confirm with trial site).
• People with other uncontrolled medical conditions that the trial doctors consider unsuitable for participation.
• People living with HIV/AIDS.
• People in any situation that the trial doctors believe could increase risk to the participant or affect the reliability of the trial results.

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