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 diagnosed with a specific type of leukemia called CML (chronic myeloid leukemia) that is linked to a genetic change known as the Philadelphia chromosome or BCR-ABL, where diagnosis was made within the last 12 months (called "early chronic phase").
• People who have had little or no prior treatment — a medication called hydroxyurea and/or 1–2 doses of another drug called cytarabine are allowed, and less than one month of a targeted cancer drug (called a TKI) is also allowed.
• People whose leukemia shows certain additional chromosome changes at the time of diagnosis, but no other signs of more advanced disease, may still be considered eligible (confirm with trial site).
• People who are reasonably physically active and able to carry out daily activities, based on a standard medical scale scored 0 to 2 (where 0 means fully active and 2 means able to care for oneself but unable to do physical work).
• People whose liver and kidney function meet specific levels set by the trial (confirm with trial site for exact values).
• People who have read and signed a form confirming they understand the study is investigational and agree to take part.
• Male participants who are either surgically or biologically unable to father children, or who agree to use reliable contraception throughout the study and for 3 months after the last dose of the study drug.

Who may not be able to join:

• People with serious heart disease classified as Class 3 or 4 on a standard medical scale (meaning significant limitations on physical activity or symptoms even at rest).
• People with certain heart-related conditions, unless a heart specialist (cardiologist) has reviewed and cleared them, including: uncontrolled chest pain (angina) in the past 3 months; a diagnosed or suspected inherited heart rhythm condition called long QT syndrome; a history of serious irregular heart rhythms; or an abnormal heart rhythm reading (QTc interval over 460 milliseconds) on a heart tracing (ECG) done before the study.
• People with a history of significant bleeding disorders unrelated to cancer — such as an inherited bleeding condition (e.g., von Willebrand's disease) or a bleeding disorder diagnosed within the past year — unless a blood specialist has reviewed and cleared them.
• People with active and uncontrolled mental health conditions, including psychosis, major depression, or bipolar disorder.
• People known to be living with HIV.
• People with active, uncontrolled infections (viral, bacterial, or fungal).
• People with chronic hepatitis B or hepatitis C requiring ongoing treatment. (Note: people with evidence of prior hepatitis B vaccination or certain antibody patterns from past intravenous immunoglobulin treatment may still be considered eligible — confirm with trial site.)
• Women who are pregnant or breastfeeding.
• Women who could become pregnant and do not agree to use reliable contraception throughout the trial and for at least 3 months after the last dose of the study drug.
• Women who could become pregnant must have a negative pregnancy test before starting the study drug; if the test is positive, enrolment would not proceed.
• People whose CML is in a later or more advanced stage — including late chronic phase (diagnosed more than 12 months ago), accelerated phase (with specific features such as high levels of certain abnormal cells or low platelets), or blast phase (a more aggressive stage of the disease).

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