Phase 2 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 to 65 years (male or female)
• People diagnosed with a specific type of acute lymphoblastic leukaemia (ALL) that carries a genetic marker known as Philadelphia chromosome or BCR-ABL1 positive
• People who have had little or no prior treatment — only limited early treatments such as steroids, certain preparatory chemotherapy drugs, or the very start of standard treatment for this type of leukaemia are permitted (confirm with trial site for exact details)
• People with a general health and activity level rated as reasonably good (ECOG performance status of 0, 1, or 2 — meaning able to carry out at least some daily activities)
• People who have had genetic/molecular testing done to confirm the BCR-ABL1 marker in their leukaemia
• Women who are not currently pregnant, confirmed by a negative pregnancy test
• Women who could become pregnant and are willing to use two highly effective forms of contraception during treatment and for at least 3 months after the last dose; men with a female partner who could become pregnant must also agree to the same
• People with normal blood levels of potassium and magnesium (or levels that have been corrected to normal with supplements before starting the study medication)
• People with a blood enzyme called lipase at an acceptable level (no more than 1.5 times the upper limit of normal)
• People with a normal heart electrical reading (QTcF interval) — up to 450 milliseconds for males and 470 milliseconds for females
• People who have signed and dated a written consent form agreeing to take part
• People willing to be registered with the German Multicenter Study Group for Adult ALL (GMALL)

Who may not be able to join:

• People who have been diagnosed with another type of cancer within the past 5 years (some exceptions may apply — confirm with trial site)
• People for whom any of the study drugs — Imatinib, Ponatinib, chemotherapy, or Blinatumomab — are medically unsuitable or contraindicated
• People who have previously been treated with a class of drugs called tyrosine kinase inhibitors
• Women who are currently breastfeeding
• People with known serious heart problems (confirm with trial site for specific conditions)
• People with symptoms of poor blood circulation in the arms or legs (peripheral vascular disease)
• People who have ever had a stroke or a transient ischaemic attack (sometimes called a "mini-stroke")
• People with uncontrolled high levels of a type of fat in the blood called triglycerides
• People with certain significant neurological (brain or nervous system) conditions — either past or present (confirm with trial site for specifics)
• People with a history of, or currently active, significant autoimmune disease (where the immune system attacks the body)
• People with a known allergy to immunoglobulins or to any ingredient in the study drugs
• People known to have HIV, or who have an active Hepatitis B or C infection
• People who have had pancreatitis (inflammation of the pancreas) within the 6 months before starting the trial treatment
• People who are currently taking part in another clinical trial or have received another experimental treatment within the past 30 days
• People with significantly reduced liver function, based on specific blood test results (confirm with trial site for exact values)
• People with elevated bilirubin levels in the blood above a certain threshold, unless this is due to the leukaemia itself or a specific inherited condition (confirm with trial site)
• People with other serious, uncontrolled illnesses — such as severe infections — that would make receiving the treatment unsafe
• People who are unable or unwilling to give written informed consent

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