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:

Cohort 1 (Newly diagnosed AML or high-risk MDS — generally age 60 and older)

• People diagnosed with AML (acute myeloid leukaemia) for the first time, or with high-risk MDS (a bone marrow condition with at least 10% abnormal cells or a high-risk score), who have not yet received main treatment for it
• Some limited prior treatments are permitted, including hydroxyurea, certain growth factors, azacytidine, ATRA, or a small amount of a drug called cytarabine
• People whose MDS has turned into AML may be considered regardless of what treatment they had for MDS, as long as this would be their first main AML treatment
• People aged 60 or older; people under 60 who are considered unsuitable for standard intensive treatment may also be considered after discussion with the lead investigator
• People whose liver is working well enough (specific blood test values must fall within set limits)
• People whose kidneys are working well enough (specific blood test values must fall within set limits)
• People who are reasonably able to carry out daily activities, based on a standard medical fitness scale (score of 0, 1, or 2 out of 4)
• Women who could potentially become pregnant must have a negative pregnancy test within one week before joining
• People who are able to understand what the study involves and are willing to sign a consent form
• People who have previously received a drug called decitabine, unless their condition progressed to AML while they were taking it

Cohort 2 (Newly diagnosed AML — age 18 and older, with reduced organ function or lower fitness)

• People diagnosed with AML for the first time who are not currently eligible for other frontline AML clinical trials
• The same rules about prior treatments apply as in Cohort 1
• People aged 18 or older who are considered unsuitable for standard intensive treatment, after discussion with the lead investigator
• People who meet at least one of the following: kidney function below a set threshold (creatinine at or above 2 mg/dL), liver function below a set threshold (bilirubin at or above 2 mg/dL), a lower fitness score on the standard medical scale (3 or 4 out of 4), or being ineligible for a higher-priority clinical trial (confirm with trial site)
• Women who could potentially become pregnant must have a negative pregnancy test within one week before joining
• People who are able to understand what the study involves and are willing to sign a consent form
• People who have previously received decitabine, unless their condition progressed to AML while they were taking it

Cohort 3 (Relapsed or treatment-resistant AML)

• People with AML that has come back or has not responded to treatment, and who have already received at least one prior AML treatment
• People aged 18 or older
• People whose liver is working well enough (specific blood test values must fall within set limits)
• People whose kidneys are working well enough (specific blood test values must fall within set limits)
• People who are reasonably able to carry out daily activities, based on a standard medical fitness scale (score of 0, 1, or 2 out of 4)
• Women who could potentially become pregnant must have a negative pregnancy test within one week before joining
• People who are able to understand what the study involves and are willing to sign a consent form
• People who have previously received a drug called venetoclax

Who may not be able to join:

• People who are currently pregnant, as the study drugs carry risks of harm to an unborn baby
• People who are currently breastfeeding, as the study drugs may pose risks to a nursing infant
• People with serious uncontrolled health conditions, such as an active uncontrolled infection, severe heart problems, uncontrolled irregular heartbeat, or mental health or personal circumstances that would make it difficult to follow the study requirements (note: for Cohort 2, exceptions may apply if these conditions are judged to be directly caused by the leukaemia itself — confirm with trial site)
• People who have had a known allergic reaction to any of the drugs used in this study
• People who are capable of having children and are not willing to use contraception throughout the study period

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