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 been formally diagnosed with a specific type of blood cancer called AML (but not the subtype known as acute promyelocytic leukemia with the t(15;17) change), as defined by recognised international classification standards
• People whose AML responded well (complete or near-complete remission) to a first-line treatment combining a hypomethylating agent (HMA) and venetoclax, as assessed by their treating doctor using standard guidelines
• People whose AML has a specific genetic change called an IDH1-R132 mutation (present at 0.01% or more), detected in bone marrow or blood either at the time of diagnosis or after starting HMA-venetoclax treatment
• People who are currently receiving their first course of HMA-venetoclax treatment and have completed no more than 4 cycles at the time of joining the trial, and who are able to stop venetoclax at least 1 week (or 5 half-lives, whichever is shorter) before starting the study treatment
• People who are considered suitable candidates for standard azacitidine treatment by their doctor
• People with a general physical functioning level rated at 2 or below on the ECOG scale (meaning able to care for themselves, though not always able to do active work), or a Karnofsky score of 50% or higher (confirm with trial site)
• People who have not previously received a solid organ transplant (such as a kidney or liver transplant)
• People whose side effects from prior treatment have largely resolved to mild or baseline levels (with the exception of infertility or hair loss)
• People aged 18 or older at the time of giving consent
• People whose kidneys are functioning at a sufficient level, with a creatinine clearance of at least 40 mL/min as measured by a standard formula or urine test
• People whose liver enzyme levels (ALT and AST) are within acceptable ranges — no more than 3 times the upper limit of normal
• People whose bilirubin (a liver-related substance in the blood) is within acceptable limits — no more than 2 times the upper limit of normal, with some exceptions allowed for people with a condition called Gilbert's syndrome or certain types of anaemia (confirm with trial site)
• People whose blood clotting test results (PT/INR and aPTT) are within acceptable ranges — no more than 1.5 times the upper limit of normal
• People who are willing and able to use adequate contraception (hormonal, barrier methods, or abstinence) before, during, and for 90 days after the last dose of the study drug (applies to people who could become pregnant, men, and their partners)
• People who are willing and able to sign and date the informed consent form before any study procedures begin

Who may not be able to join:

• People who have previously received a treatment that specifically targets IDH1
• People who have received any AML treatment other than HMA-venetoclax
• People with a history of a different cancer, unless they have been free of that cancer for at least 12 months and their doctor considers them at low risk of it returning — some exceptions apply for certain skin cancers, cervical cancer in situ, and breast ductal carcinoma in situ diagnosed or treated within the past 12 months (confirm with trial site)
• People with AML or cancer that has spread to the brain or spinal cord, or that is causing urgent problems such as severe pain, bone fractures, or pressure on the spinal cord that require immediate treatment
• People who have previously had a stem cell transplant (from another person) for a condition other than AML, if that transplant was fewer than 100 days ago, if they are currently experiencing graft versus host disease (a complication of transplants), or if they are taking immune-suppressing medications for that complication — low-dose steroids below a certain threshold may still be acceptable (confirm with trial site)
• People who have received radiation therapy or major surgery requiring general anaesthesia within 2 weeks before the study drug would start
• People who are unable to swallow tablets or capsules, or who have gut or digestive conditions that their doctor believes would prevent the study drug from being properly absorbed
• People with serious heart conditions, including severe heart failure, unstable chest pain (angina), a heart attack within the past year, uncontrolled high blood pressure, or uncontrolled abnormal heart rhythms
• People with a specific heart electrical measurement (QTcF interval) above 480 milliseconds at the start of the trial — note that this rule may not apply to people with a particular heart conduction condition called bundle branch block (confirm with trial site)
• People who are taking certain medications known to cause a serious heart rhythm problem called Torsades de Pointes, if those medications were started recently and have not yet reached a stable level in the body — some commonly used supportive medications used as needed are exempt (confirm with trial site)
• People who are regularly taking corticosteroid (steroid) medications at doses above a low daily threshold — short-course or as-needed steroids for reactions may be allowed (confirm with trial site)
• People with a known history of HIV infection
• People with active, uncontrolled infections caused by bacteria, viruses, or fungi that require ongoing treatment — preventive antibiotic or antifungal treatment is allowed
• People with uncontrolled metabolic problems related to their disease, such as very high calcium levels in the blood
• People who are pregnant, breastfeeding, or planning to become pregnant during the trial or within 90 days after the last dose of the study drug — stored breast milk cannot be used while the mother is on study treatment
• People who plan to donate sperm or attempt to conceive a child during the trial or within 90 days after the last dose of the study drug
• People who are unwilling or unable to follow the procedures required by the trial or considered standard care
• People with medical, psychiatric, cognitive, or other conditions that their doctor believes would prevent them from understanding the trial information, giving informed consent, or following the study requirements

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