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:

• People who have been diagnosed with a specific type of blood cancer called AML (but not the APL subtype), confirmed according to standard medical guidelines, and who have either received at least one prior treatment (for the relapsed/refractory groups) or have not yet received any treatment (for the newly diagnosed group). Prior use of hydroxyurea or ATRA is allowed in the newly diagnosed group.
• People in the newly diagnosed group who are considered unlikely to tolerate strong, intensive chemotherapy because of their age, general health status, or other health conditions — for example, being aged 75 or older, or being under 75 with certain heart, lung, or kidney conditions, a lower physical functioning score, or other conditions the doctor judges to be incompatible with intensive chemotherapy.
• People with a general physical functioning score (ECOG scale) of 0–3 if under 75 years old, or 0–2 if aged 75 or older.
• People who are eligible for a stem cell transplant may still join, and the trial allows them to proceed with a transplant at any point during the study.
• People who are expected to live for at least 12 weeks.
• People whose kidneys are working well enough, as measured by a specific kidney function calculation (creatinine clearance of at least 30 mL/min).
• People whose liver is functioning adequately, based on specific blood test results for liver enzymes and bilirubin — unless any abnormal results are caused by the leukaemia itself, or by a harmless inherited condition called Gilbert's syndrome.
• Male participants who are not surgically sterile must agree to use contraception with their partner(s) from before starting the study drug until 90 days after the last dose, and must not donate sperm during this period. Contraception is not required if the male participant has had a vasectomy confirmed by a doctor, or if their female partner cannot become pregnant.
• Female participants must either be post-menopausal (over 60 with no periods for 12 or more months without another medical explanation), have had surgery that means they cannot become pregnant (such as removal of both ovaries, fallopian tubes, or the uterus), or — if they could become pregnant — must use contraception while on the study drug and for 6 months after the last dose.
• People who are willing to sign a consent form that has been reviewed and approved by an ethics board, before any study-related procedures begin.
• People who are willing to avoid eating grapefruit, grapefruit products, Seville oranges (including marmalade made with Seville oranges), or star fruit for 3 days before starting the study drug and for the entire time they are in the trial.

Who may not be able to join:

• People whose AML has spread to the brain or spinal cord.
• People who are known to be HIV positive (HIV testing is not required to join, but a known positive result is an exclusion).
• People known to have an active hepatitis B or hepatitis C infection with detectable virus levels. People with evidence of past hepatitis B vaccination, or with undetectable viral levels, may still be considered. Testing is not required.
• People who have significant active heart disease within the past 6 months, such as severe heart failure, unstable chest pain (angina), or a recent heart attack.
• People with serious ongoing conditions affecting the kidneys, nervous system, mental health, hormones, immune system, liver, heart/blood vessels, or bleeding — that are unrelated to the leukaemia — if the doctor judges these would be unsafe during the trial.
• People who have a condition that prevents them from absorbing medication taken by mouth, such as Crohn's disease, ulcerative colitis, coeliac disease, or a history of major stomach or bowel surgery.
• People with an active infection (viral, bacterial, or fungal) that is not under control despite appropriate treatment.
• People with a history of another cancer, with some exceptions — including certain skin cancers, early-stage breast or cervical cancer that was treated, prostate cancer managed with hormonal therapy only, or a previous cancer that was fully removed or treated with the aim of a cure.
• People with a very high white blood cell count (above 25 × 10⁹/L) — though the trial notes that certain treatments to lower this count before joining may be permitted.
• People who are suitable for, and willing to receive, standard intensive chemotherapy.
• People who are pregnant or breastfeeding. A pregnancy test will be done at the screening stage.
• People with a known or suspected allergy to azacitidine or mannitol (ingredients related to the study drug).

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