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 diagnosed with a type of blood cancer called AML (acute myeloid leukemia), or a related leukemia that includes a myeloid component, whose cancer has not responded to or has come back after previous treatment — including cases where the leukemia is found outside the bone marrow.
• Older adults (over 60 years old) newly diagnosed with AML who are not suitable for intensive chemotherapy.
• People diagnosed with AML who previously had a blood disorder called MDS (myelodysplastic syndrome) or CMML (chronic myelomonocytic leukemia), regardless of what treatment they received before.
• People who have a specific genetic change called an IDH2 mutation, confirmed by testing.
• People with a general health/functioning level rated at 3 or below on a standard medical scale (ECOG), meaning people who are able to carry out some self-care but may spend more than 50% of waking hours in bed are included (confirm with trial site).
• People with kidney function within an acceptable range (a blood test result called creatinine below 2, unless the leukemia itself is causing a higher result).
• People with liver-related blood test results within acceptable ranges, with some exceptions if results are affected by a condition called Gilbert's disease or by the leukemia itself.
• People who are able and willing to provide written consent to participate.
• Women who cannot become pregnant (due to surgery, biology, or menopause for at least 12 months), or women who could potentially become pregnant and have a negative pregnancy test within 72 hours before starting treatment.
• Women who could potentially become pregnant, and men, who agree to use an adequate form of contraception during the trial and for 3 months after the last treatment.

Who may not be able to join:

• People whose leukemia involves a specific chromosomal abnormality called t(15;17), or who have a subtype of AML known as acute promyelocytic leukemia (M3-AML).
• People with serious, uncontrolled health conditions, such as an active uncontrolled infection, high blood pressure that cannot be controlled with medication, severe heart failure (classified as NYHA class III or IV), or a significant uncontrolled irregular heartbeat.
• People with any other medical, mental health, or social condition that the trial doctor believes could interfere with safe participation in the study.
• People who are currently pregnant or breastfeeding.

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