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 have given their written consent to participate (or have a legally authorised representative do so on their behalf)
• People who have been diagnosed with a type of leukaemia called Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL), confirmed by laboratory testing at any point before cellular therapy
• People who are either scheduled for, or have recently received (within the last 30 days), a stem cell transplant (Arm 1) or a CAR T cell infusion (Arm 2)
• People who are between 30 and 150 days after their stem cell transplant or CAR T cell therapy, and whose bone marrow has fully recovered and engrafted
• People whose bone marrow assessment around day 30 after cellular therapy shows the leukaemia is in complete remission (fewer than 5% abnormal cells, no disease outside the bone marrow, and no longer needing blood transfusions)
• People who show no signs of the leukaemia returning
• People whose neutrophil count (a type of infection-fighting white blood cell) has been at or above a minimum level for at least 3 days (growth factor support is permitted)
• People whose platelet count is at or above the required minimum level
• People whose haemoglobin (a measure of red blood cells) is at or above the required minimum level
• People whose liver function test results (bilirubin, AST, and ALT) are within acceptable ranges — people with a condition called Gilbert's disease may still be considered for the bilirubin criterion (confirm with trial site)
• People whose kidney function, as measured by a blood test, is within the acceptable range
• People whose heart pumping function (left ventricular ejection fraction) is at or above 50%, tested within 28 days before starting the study treatment
• People whose heart's electrical activity (a specific measurement called QTcB) is within the acceptable range, tested within 28 days before starting the study treatment
• People whose blood oxygen level on room air is above 90%
• People who test negative for HIV, hepatitis B, and hepatitis C — or, if positive for one of these, whose virus level is undetectable (people living with HIV on effective treatment with an undetectable viral load within the past 6 months may still be considered)
• People who meet all required infectious disease testing results within 28 days before starting treatment
• Women who could become pregnant must have a negative pregnancy test before starting the study
• People of childbearing potential who agree to use effective contraception or abstain from heterosexual activity throughout the study and for at least 120 days after the last dose of study treatment
• People whose general physical functioning meets a standard medical scale score of 2 or below (meaning they are able to care for themselves and are up and about for more than half of waking hours) (confirm with trial site)

Who may not be able to join:

• People who have previously been treated with the study drug asciminib and it did not work
• People currently taking certain medications known to strongly interact with the study drug (a switch to an alternative medication at least one week before starting would be required — confirm with trial site)
• People with certain heart conditions, including a heart attack or coronary artery bypass surgery within the 6 months before starting the study, significant heart rhythm problems, or a specific heart electrical measurement (QTcF) above the stated thresholds at the time of screening
• People with a personal or family history of a heart condition called long QT syndrome, or a family history of unexplained sudden death
• People who have had pancreatitis (inflammation of the pancreas) within the past year, or who have a history of chronic pancreatitis
• People on Arm 1 (stem cell transplant) who have active, severe graft-versus-host disease (a condition where the transplanted cells attack the body) within 14 days of enrolling, or who are receiving medications other than a specified low dose of prednisone to control it
• People with a serious uncontrolled illness
• People with an active infection that is not responding to treatment
• People with another active cancer, unless that cancer or its treatment is unlikely to affect the safety or results of this trial (confirm with trial site)
• Women who are pregnant or breastfeeding
• People with any other condition that the treating doctor believes would make participation unsafe
• People who, in the treating doctor's judgement, may not be able to follow all study procedures

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