Phase 1 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:

• Adults aged 18 or older who are considered not suitable for intensive chemotherapy, for at least one of the following reasons: aged 75 or older; limited physical functioning (ECOG score of 2–3); a serious heart condition such as heart failure requiring treatment, reduced heart pumping function, or chronic stable angina; a serious lung condition with reduced breathing capacity; reduced kidney function (confirm with trial site for specific values); a liver condition causing elevated bilirubin levels; or another health condition that the study doctors determine makes intensive chemotherapy unsuitable
• People newly diagnosed with a type of blood cancer called acute myeloid leukemia (AML) — but not a specific subtype called APL — and without certain genetic features listed in the exclusion criteria below
• People whose liver enzyme levels and blood clotting measures fall within acceptable ranges at the time of screening (confirm with trial site for specific values)
• People with a history of a pre-leukemia bone marrow condition called MDS, provided they have not previously received chemotherapy or certain medicines called hypomethylating agents (such as azacitidine or decitabine)
• People who developed AML as a result of prior radiation or chemotherapy for another cancer, provided they have not previously received hypomethylating agents or a medicine called venetoclax
• People with very high white blood cell counts may still be considered, provided a specific short-term treatment to reduce those counts is given before the trial treatment begins
• Female participants of childbearing potential who have a negative pregnancy test at screening
• People who are willing and able to understand and sign a written consent form
• Both male and female participants of childbearing potential who agree to use an adequate method of contraception from screening until 6 months after the last dose of study treatment

Who may not be able to join:

• People who have already received treatment for their AML (except for specific short-term medicines used to reduce very high white blood cell counts)
• People with a known allergy or sensitivity to ascorbate (high-dose vitamin C), azacitidine, decitabine, or venetoclax
• People whose AML has specific genetic features, including certain chromosomal changes or gene mutations (such as NPM1, IDH1, IDH2, FLT3-ITD, FLT3-TKD, KMT2A rearrangement, or others — confirm with trial site for the full list)
• People with kidney disease requiring dialysis, diabetic kidney disease, a history of kidney transplant, or a history of a specific type of kidney damage caused by oxalate
• People with a condition causing the body to store too much iron, or persistently very high iron storage levels in the blood
• People with type 1 or type 2 diabetes who are on short-acting insulin and require at least daily finger-stick blood glucose monitoring
• People with another current or previous cancer whose condition or treatment could interfere with the safety or results of this trial
• People with other serious health conditions that the treating doctor considers makes participation unsuitable
• People with HIV that is not controlled by anti-retroviral medication (people with HIV whose viral load has been undetectable within the past 6 months on effective treatment may still be considered)
• People with a genetic condition called G6PD deficiency
• People taking warfarin or certain other medicines that strongly interact with the trial drugs, if a suitable substitute medicine cannot be or is not agreed to be used

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