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 who have given written consent to take part in the study.
• People diagnosed with acute myeloid leukaemia (AML) — a type of blood cancer — but not a specific subtype called acute promyelocytic leukaemia (APL).
• People whose AML is either newly diagnosed or developed from a prior condition, and who are not suitable for standard intensive chemotherapy.
• People whose AML has come back or stopped responding to treatment, after having had at least one previous treatment.
• People who also give written consent to have their blood or tissue samples stored and tested in a laboratory (including genetic and drug sensitivity testing) as part of research — noting that all participants receive the same treatment regardless of these test results.
• People aged 75 or older who have a general health/activity level rated at a moderate level or better (confirm with trial site for exact rating); or people aged 18 to 74 with a slightly lower health/activity level still within an acceptable range (confirm with trial site).
• People whose white blood cell count is below a certain level (a medication called hydroxyurea may be used beforehand to bring levels within range).
• People whose kidneys are working well enough, based on a standard calculation of kidney function (confirm with trial site for the exact threshold).
• People whose liver is working well enough, based on two specific blood test results being within acceptable ranges (confirm with trial site).
• Older or less fit AML patients who meet at least one of the following: aged 70 or older; or aged 18–69 and not suitable for intensive chemotherapy due to a significant health condition (such as reduced heart or lung function, heart disease managed with medication, or a specific liver enzyme level); a documented reason not to use certain chemotherapy drugs; high-risk genetic features of their AML; a personal choice not to have intensive chemotherapy; or AML that developed after previous treatment for a related blood condition.
• People with relapsed AML who are aged 55 or older with a non-CBF type of AML (confirm with trial site); or aged 18 or older and either not suitable for intensive chemotherapy, having relapsed after chemotherapy or a stem cell transplant (up to but not including a fourth relapse), or choosing not to have intensive chemotherapy.
• People with AML that has not responded to previous treatment with certain chemotherapy regimens or a medication class called HMA (confirm with trial site for specific regimens).

Who may not be able to join:

• People with the APL subtype of leukaemia.
• People who have had four or more relapses of AML.
• People whose bone marrow or blood shows fewer than 10% leukaemia cells (blast cells).
• People whose general health and activity level falls below the minimum required threshold (confirm with trial site).
• People who have previously been treated with a drug called venetoclax for a blood or bone marrow condition.
• People whose AML has spread to the central nervous system (brain and spinal cord).
• People with HIV, or with hepatitis B or C that is not being successfully controlled with antiviral medication.
• People with heart disease that causes symptoms such as palpitations, fatigue, breathlessness, or chest pain during ordinary everyday activities.
• People with certain serious ongoing health conditions, including: a breathing condition requiring continuous oxygen use; an active, uncontrolled infection (viral, bacterial, or fungal); a condition that prevents swallowing or absorbing oral medication; or uncontrolled graft-versus-host disease (a complication that can occur after a stem cell transplant).
• People with a history of another cancer, unless it was fully treated with the intent to cure, or is considered a very slow-growing type (the trial doctor will assess this).
• People who are pregnant or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 7 days before starting treatment.
• People who are able to have children and are not willing to use two forms of contraception (including one highly effective method) during treatment and for 3 months afterwards — unless they have been surgically sterilised or have not had a period for 2 or more years.
• People with a known allergy to venetoclax, azacitidine, or any ingredients in these medications.

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