Early 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 male, or female and neither pregnant nor breastfeeding
• People who have been newly diagnosed with a specific type of acute lymphoblastic leukaemia (ALL) that tests positive for a genetic marker called Philadelphia chromosome or BCR-ABL1, and who have not yet received any targeted therapy (TKIs) or chemotherapy for this condition
• People who are reasonably active and able to care for themselves, with a general health status score of 2 or less on a standard medical scale, and an expected survival of at least 3 months
• People whose liver function tests are within acceptable ranges (liver enzymes no more than 5 times the upper limit of normal, and bilirubin less than twice the upper limit of normal)
• People whose kidneys are functioning well enough (a specific kidney clearance measure above 30 mL/min)
• People whose blood oxygen level is 92% or above
• People whose heart pumping function is at least 40% on an ultrasound measurement

Who may not be able to join:

• People with active Hepatitis B (with a virus level at or above a specific threshold), active Hepatitis C, HIV, or active syphilis at the time of enrolment (confirm with trial site regarding lower-level Hepatitis B, as separate monitoring rules may apply)
• People with an active infection that is not currently under control
• People who currently have, or have a history of, an active autoimmune disease that could affect the brain or nervous system
• People with a history of heart or blood vessel disease, including high blood pressure (above 140/90 mmHg)
• People whose heart ultrasound shows elevated pressure in the lung's blood vessels (above 50 mmHg), or who have symptoms related to high blood pressure in the lungs
• People who have a serious bleeding disorder that is unrelated to their leukaemia diagnosis
• People who have another type of cancer that currently requires treatment
• People with severely elevated triglyceride (fat) levels in their blood (at or above a specific threshold)
• People who are pregnant, planning to become pregnant, or currently breastfeeding
• People who had major surgery within 14 days before the start of the trial (minor procedures such as port placement or bone marrow biopsy are generally not included in this restriction — confirm with trial site)
• People who may be unable to attend all required study visits, follow-up appointments, or complete all study procedures
• People whose overall health condition, in the treating doctor's judgement, could put them at risk or affect how the trial drug is evaluated

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