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 diagnosed with CMML (a type of blood cancer) that has not responded to treatment — specifically, those who have either tried at least 4 cycles of standard medicines called hypomethylating agents (or hydroxyurea for a certain type of CMML) without improvement, stopped early due to side effects, or whose disease has gotten worse during treatment.
• People with a type of acute myeloid leukaemia (AML) that has come back or stopped responding to treatment, where the cancer cells are mainly a type called monocytic (meaning at least half the abnormal cells are of a specific type), certain markers are present on those cells, and blood cell counts are within specific limits.
• People whose general physical functioning is rated at a level of 0, 1, or 2 on a standard medical scale (meaning they are able to carry out most daily activities, with or without some limitations).
• People whose life expectancy is more than 2 months and who are considered stable enough to complete two cycles of the study treatment, in the opinion of the treating doctor.
• People with adequate organ function (confirm with trial site for specific requirements).
• People who are able and willing to use acceptable birth control methods throughout the study and for 90 days after the last dose of the study treatment — this applies to both women who could become pregnant and men.
• People who are able to understand and willing to sign a written consent form agreeing to take part.
• People who are willing and able to follow all study procedures and attend follow-up appointments.

Who may not be able to join:

• People with blood or bone marrow conditions that overlap with CMML but are not CMML itself, or people with AML of a specific type called Acute Promyelocytic Leukaemia (APL), or AML that exists only outside the bone marrow.
• People who are considered immediately eligible for a stem cell transplant from a donor.
• People who currently use any nicotine products, including cigarettes, tobacco, nicotine patches, or vaping devices.
• People who had a bone marrow transplant within the past 6 months, or who received transplant-related immune-suppressing medicines within the past 3 months.
• People with an active autoimmune condition that requires immune-suppressing treatment (low-dose steroids and certain inhaled or topical treatments may be acceptable — confirm with trial site).
• People who received chemotherapy, biological therapy, or wide-field radiation within 14 days before joining (there are specific exceptions for a medicine called hydroxyurea — confirm with trial site).
• People who received another experimental treatment within 30 days before the study drug would be given.
• People who received certain blood cell growth-stimulating medicines (such as G-CSF, GM-CSF, erythropoietin, or similar) within 2 weeks before the first dose.
• People who received a live or live-attenuated vaccine within 30 days before the first dose.
• People with significant heart or cardiovascular problems, such as severe heart failure, unstable chest pain, a heart attack or stroke within the past 6 months, uncontrolled high blood pressure, or serious irregular heart rhythms not controlled by medication.
• People with a specific heart electrical measurement (QTcF interval) above a set threshold on a heart tracing test (confirm with trial site for exact values and any adjustments needed).
• People with another active cancer requiring ongoing treatment, other than certain low-risk conditions such as non-melanoma skin cancer, certain in-place (non-spreading) cancers, or early-stage prostate cancer with no signs of progression.
• People with an active, uncontrolled infection caused by bacteria, fungi, or a virus.
• People known to have HIV.
• People with active or ongoing hepatitis B or hepatitis C infection.
• People with other severe or unstable health conditions, psychiatric conditions, or other circumstances that the treating doctor believes could affect safety or the ability to take part properly.

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