Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-24 @ 3:04 PM
NCT ID:
NCT04554459
Eligibility Criteria:
Inclusion Criteria:
* Patients with newly diagnosed, previously untreated, Ph-positive \[either t(9;22) and/or BCR-ABL positive\] B-precursor acute lymphoblastic leukemia;
* Age more than 18 years;
* Eligible to intensive chemotherapy, due to general health status;
* ECOG (Eastern Cooperative Oncology Group) performance status ≤2;
* Absence of significant liver disease, as defined by the following criteria: total serum bilirubin ≤1.5 x upper limit of normal (ULN), unless due to Gilbert's syndrome, alanine aminotransferase (ALT) ≤2.5 × ULN or ≤5 x ULN if leukemic involvement of the liver is present, and aspartate aminotransferase (AST) ≤2.5 × ULN or ≤5 x ULN if leukemic involvement of the liver is present;
* Adequate pancreatic function as defined by serum amylase and lipase ≤1.5 × ULN;
* Diagnostic sample of bone marrow (or peripheral blood with \>50% of blasts) available for central MRD assessment;
* Subject has provided written informed consent prior to any screening procedure.
Exclusion Criteria:
* Lymphoid blast crisis of chronic myelocytic leukemia (CML);
* Active serious infection not controlled by oral or intravenous antibiotics;
* Active known hepatitis B virus (HBV) or hepatitis C virus (HCV) or positive HIV serology;
* History of acute pancreatitis within 1 year of study or history of chronic pancreatitis;
* Uncontrolled hypertriglyceridemia (triglycerides \> 5.1 µmol/L);
* Clinically significant, uncontrolled or active cardiovascular disease, specifically including, but not restricted to: any history of myocardial infarction, stroke, or revascularization; unstable angina or transient ischemic attack within 6 months prior to enrolment; congestive heart failure within 6 months prior to enrolment or left ventricular ejection fraction (LVEF) less than lower limit of normal per local institutional standards; history of clinically significant (as determined by the treating physician) atrial arrhythmia; any history of ventricular arrhythmia; any history of venous thromboembolism including deep venous thrombosis or pulmonary embolism;
* Uncontrolled hypertension (diastolic blood pressure \>90 mmHg; systolic \>140 mmHg). Patients with hypertension should be under treatment on study entry to effect blood pressure control;
* Creatinine levels \> 160 µmol/L or estimated creatinine clearance of \< 50 mL/min;
* GI disease and/or major GI surgery that may significantly alter the absorption of study drug
* Hypersensitivity to the active substance or to any of the excipients, especially galactose intolerance.
* Taking any medications or herbal supplements that are known to be strong inhibitors of CYP3A4 within at least 14 days before the first dose of ponatinib;
* Female patients who are pregnant or breast feeding or patients of childbearing potential not willing to use a highly effective method of contraception during the study and for 3 months following the last dose of study drug;
* Male patients whose sexual partner(s) are women of childbearing potential who are not willing to use a highly effective method of contraception, one of which includes a condom, during the study;
* Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention;
* Any concurrent severe and/or uncontrolled medical condition, which could, in the opinion of the investigator, compromise participation in the study;
* Concurrent participation in another clinical study with an investigational medical product.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT04554459
Study Brief:
Protocol Section:
NCT04554459