Phase 2 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 diagnosed with Acute Myeloid Leukemia (AML) that has come back or stopped responding to treatment, after trying at least one standard treatment and one further "rescue" treatment, or where further rescue treatment is not considered a suitable option
• People diagnosed with Myelodysplastic Syndrome (MDS) that has come back or stopped responding to treatment, where further rescue treatment is not considered suitable, and whose condition is classified as high-risk or very high-risk using a specific scoring system called the IPSS-R
• People who are not considered suitable candidates for a stem cell transplant from a donor
• People who have a negative pregnancy test (blood or urine)

Who may not be able to join:

• People with certain specific genetic subtypes of AML (Inv(16), t(8;21), or PML/RARA) who are still eligible for targeted therapies
• People who have signs or symptoms suggesting leukemia has spread to the brain or spinal cord, or who have a confirmed diagnosis of this
• People currently taking medications that suppress the immune system
• People who have had a stem cell transplant within the 3 months before the first study visit
• People who have an active infection that requires antibiotic or antiviral treatment given through a drip (intravenously) during the screening period
• People with other serious or uncontrolled health conditions that, in the doctor's judgment, could put them at risk or affect their ability to take part in the study
• People who have received cancer treatment within 14 days before the first study visit
• People who have taken part in another clinical trial involving a drug or medical device within 21 days before the first study visit
• People who have had radiotherapy within 28 days before the first study visit
• People with a confirmed positive test for HIV, active Hepatitis C, active Hepatitis B, active COVID-19, Syphilis, Cytomegalovirus (CMV), Epstein-Barr virus (EBV), or HTLV1
• People who have had another type of cancer in the 12 months before the first study visit
• People who currently have another active solid tumour (a cancer forming a mass in the body)
• People with moderate to severe heart failure (classified as NYHA Class III or IV), or whose heart pumping function is below 50% on a heart scan taken within 28 days before the first study visit
• People who have had a heart attack within the 3 months before the first study visit
• People who have a specific abnormality in their heart's electrical activity (QTc interval of 450ms or more), or other factors that increase the risk of heart rhythm problems
• People who have had major surgery within 4 weeks before the first study visit
• People with any other condition that the trial doctor believes would prevent them from participating safely or fully
• People who took part in an earlier phase of this same study and experienced a serious side effect at the dose tested (confirm with trial site)

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