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 aged 19 years or older, either male or female
• People who have been diagnosed with chronic phase chronic myeloid leukemia (CML) within the last 8 weeks, confirmed through chromosome or bone marrow testing, and whose disease meets specific blood and bone marrow measurements defined by the trial
• People whose CML has tested positive for the Philadelphia chromosome and a specific genetic marker called BCR:ABL1
• People who are well enough to carry out daily activities, rated 0, 1, or 2 on a standard health performance scale (confirm with trial site)
• People whose liver, kidneys, and pancreas are working well enough to meet specific blood test levels set by the trial
• Women who could become pregnant must have a negative pregnancy test before joining
• Women who could become pregnant must use an adequate method of contraception throughout the study and for at least 4 weeks after the last dose of the study drug
• People who have provided written consent before any trial-related screening procedures take place

Who may not be able to join:

• People whose CML tests negative for the Philadelphia chromosome
• People who have already taken the study drug Radotinib for 8 days or more before joining
• People who have previously received other targeted anti-cancer therapies, with the exception of Hydrea or Agrylin
• People with a known allergy or sensitivity to the study drug or any of its ingredients
• People with certain heart conditions, including a complete left bundle branch block, a fitted cardiac pacemaker, a personal or family history of a condition called long QT syndrome, abnormal heart rhythm measurements on an ECG, a resting heart rate below 50 beats per minute, a history of heart attack or unstable chest pain within the last 12 months, or other significant heart conditions such as heart failure or uncontrolled high blood pressure
• People with confirmed cancer involvement in the central nervous system (brain and spinal cord)
• People with severe or uncontrolled ongoing health conditions, such as uncontrolled diabetes or an active uncontrolled infection
• People with significant bleeding disorders unrelated to their leukemia
• People who have previously had radiotherapy covering 25% or more of their bone marrow
• People who have had major surgery within the 4 weeks before joining, or who have not yet fully recovered from a previous surgery
• People diagnosed with another significant cancer within the 5 years before joining, excluding a specific type of skin cancer called basal cell carcinoma
• People currently taking certain medications that strongly affect how the body processes drugs (specific CYP3A4 inhibitors or inducers), where switching or stopping is not considered safe before starting the trial
• People currently taking medications known to affect heart rhythm in a specific way (QT interval prolongation), where switching or stopping is not considered safe before starting the trial
• People with digestive system conditions that could significantly affect how the study drug is absorbed, such as ulcerative colitis, uncontrolled nausea, vomiting, diarrhea, or previous bowel surgery
• People with a history of inflammation of the pancreas (acute or chronic) within the last year
• People with acute or chronic liver or pancreas disease, or severe kidney disease
• People who test positive for hepatitis B surface antigen (HBsAg) or hepatitis C antibodies (HCV Ab), unless specific conditions assessed by the investigating doctor are met (confirm with trial site)
• People with a known or confirmed positive HIV test
• People who are pregnant or currently breastfeeding

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