ASCIMINIB HYDROCHLORIDE for Chronic myeloid leukaemia

Inclusion criteria

• {"criterion_text":"- Male or female patients with diagnosis of CP‐CML with cytogenetic confirmation of the Ph+ chromosome [t(9;22)(q34;q11)]\n- Ph‐negative cases or patients with variant translocations who are BCR‐ABL1 positive in multiplex PCR will be also considered eligible\n- ECOG performance status of ≤2\n- Age ≥ 18 years old (no upper age limit is given)\n- Serum levels of potassium, magnesium, total calcium within the normal limits (≥LLN [lower limit of normal] and ≤ULN [upper limit of normal]). Correction of electrolytes levels with supplements to fulfil enrolment criteria is allowed\n- AST and ALT ≤2.5 x ULN or 5.0 x ULN if considered due to leukemia\n- Alkaline phosphatase ≤2.5 x ULN unless considered due to leukemia\n- Total bilirubin ≤1.5 x ULN, except known Gilbert disease\n- Serum creatinine ≤2 x ULN\n- Serum lipase ≤1.5 x ULN\n- Written informed consent prior to any study procedures being performed"}

Exclusion criteria

• {"criterion_text":"- Allogeneic stem cell transplantation\n- Known impaired cardiac function, including any of the following: o Congenital long QT syndrome o History of or presence of clinically significant ventricular or atrial tachyarrhythmia o QTc >450 ms on screening ECG o Myocardial infarction within 12 months prior to starting therapy o History of clinically significant/ symptomatic bradycardia o Family history of idiopathic sudden death\n- Patients with resting QTcF ≥450 msec (male) or ≥460 msec (female) at pretreatment, or inability to determine the QTcF interval\n- Patients with uncorrected hypokalemia or hypomagnesemia\n- Other clinically significant heart disease (e.g. unstable angina, congestive heart failure)\n- Acute or chronic viral hepatitis with moderate or severe hepatic impairment (Child‐Pugh scores >6), even if controlled\n- Other concurrent uncontrolled medical conditions (e.g., active or uncontrolled infections, acute or chronic liver and renal disease) that could cause unacceptable safety risks or compromise compliance with the protocol\n- Impaired gastrointestinal function or disease that may alter the absorption of study drug (e.g., ulcerative disease, uncontrolled nausea, vomiting and diarrhea, malabsorption syndrome, small bowel resection or gastric by‐pass surgery)\n- History of acute or chronic pancreatitis\n- Concomitant medications known to be strong inducers or inhibitors of the CYP450 isoenzyme CYP3A4\n- Patients who have undergone major surgery ≤2 weeks prior to starting study drug or who have not recovered from side effects of such therapy\n- Patients who are pregnant or breastfeeding or women of reproductive potential not employing an effective method of birth control. Women of childbearing potential must have a negative serum pregnancy test within 14 days of study start. Post‐menopausal women must be amenorrheic for at least 12 months in order to be considered of non‐childbearing potential.\n- Male and female patients must agree to employ an effective method of birth control throughout the study and for up to 2 weeks following discontinuation of study drug. (It is required that sexually active men use condom during intercourse while taking the drug and for 2 weeks after stopping treatment and not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid. Female partners of male patients must be advised to use highly effective methods of contraception.)\n- Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory)\n- Known serious hypersensitivity reactions to asciminib, imatinib, nilotinib or dasatinib\n- Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention\n- Patients unwilling or unable to comply with the protocol"}

Primary endpoints

• {"endpoint_text":"- Rate of MR4 at month 12","definition_or_measurement_approach":""}

Germany

Earliest CTIS Part Ii Submission Date

19-09-2024

Latest Decision Or Authorization Date

08-10-2024

Processing Time Days

19

Number Of Sites

20

Number Of Participants

125

Primary sponsor

Full Name

Friedrich-Schiller-Universitaet Jena

Organisation Type

Educational Institution

Country Of Registered Address

Germany