Phase 2 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 in Cohorts 1–3 who have been diagnosed with MDS (myelodysplastic syndrome) according to standard medical guidelines, and whose disease is classified as low or intermediate-1 risk on standard scoring systems
• People in Cohort 4 who have been diagnosed with CCUS (clonal cytopenia of undetermined significance), meaning a specific genetic change linked to blood cancer risk is present in the blood, but there is no sign of MDS or blood cancer, the genetic change makes up at least 2% of tested cells, a bone marrow test has ruled out blood cancer and MDS, and low blood counts have been present for more than 30 days
• People in Cohort 1 whose MDS has not responded to previous treatments such as ESAs or certain chemotherapy medicines (including azacitidine, decitabine, or similar drugs), having received at least 4 treatment cycles, or whose disease has come back or worsened; people with a specific genetic change called del 5q must also have previously been treated with a medicine called lenalidomide
• People in Cohort 1 with a haemoglobin level below 10 g/dL with symptoms of anaemia, or who have needed a blood transfusion in the past 8 weeks due to low haemoglobin
• People in Cohort 2 who have needed at least 2 units of red blood cell transfusions, or any platelet transfusion, in the past 8 weeks due to low blood counts or symptoms of anaemia
• People whose liver function blood test results are within an acceptable range (confirm with trial site)
• People whose kidneys are functioning above a minimum level, with no end-stage kidney disease (confirm with trial site)
• People whose general health and ability to carry out daily activities meets a standard medical rating of 2 or below on a 5-point scale (confirm with trial site)
• People (or their legal representative) who have signed a form showing they understand and agree to take part in the study

Who may not be able to join:

• People with an active infection that is not responding adequately to antibiotic treatment
• People who have previously been treated with a specific type of medicine called an IL-1 or IL-1 receptor inhibitor
• People whose neutrophil count (a type of white blood cell) is very low, below a certain threshold (confirm with trial site; note that certain supporting medicines may be given beforehand)
• People who are pregnant or currently breastfeeding
• People who are capable of having children and are unwilling to use an accepted form of contraception throughout the study (this includes condoms for males, and for females: the contraceptive pill, contraceptive injections, an IUD, a double-barrier method, a contraceptive patch, or surgical sterilisation)
• Females capable of having children who do not have a negative pregnancy test result at the start of the study
• People who have had another active cancer diagnosis within the past 2 years, unless it was a type that has been fully treated and presents very low ongoing risk, such as certain skin cancers or early-stage cervical changes (confirm with trial site)
• People currently receiving another experimental treatment, or who have had chemotherapy, radiation therapy, or immunotherapy within 14 days of starting the study treatment
• People with a known history of HIV infection
• People who need to take systemic steroids, methotrexate, or other medicines that suppress the immune system

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