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:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-25 @ 4:16 AM
NCT ID:
NCT02917720
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Patients with Ph chromosome and/or the BCR-ABL (either b3a2 and /or b2a2) fusion gene positive CML
* CML in CP having failed a prior attempt to stop imatinib or other TKIs therapy either within EURO-SKI or not
* Pretreatment at least one year with any TKI after 1st stop
* Written informed consent
Exclusion Criteria:
* Previous hematological relapse after first stop of TKI.
* Failure to any TKI at any time during CML treatment according to current ELN criteria
* Previous planned or performed allo SCT
* Previous AP/BC at any time in the history of the disease
* High cardiac risk according to ESC score (≥ 10 Points)
* Impaired cardiac function including any of the following:
* Use of a ventricular paced pacemaker; congenital long QT syndrome or family history of; history or presence of significant ventricular or atrial tachyarrhythmias; clinically significant resting bradycardia (\<50 bpm); QTcF \>450 msec at baseline, myocardial infarction before baseline; other clinically significant heart disease (e.g., unstable angina, congestive heart failure, or uncontrolled hypertension).
* Treatment with inhibitors of CYP3A4 or medications that have been well documented to prolong the QT interval is contraindicated.
* History of acute pancreatitis within one year of study entry or medical history of chronic pancreatitis.
* Positive hepatitis B virus serology test or HBV infection
* Any other malignancy except if neither clinically significant nor requires active intervention.
* Severe or uncontrolled medical conditions (i.e., uncontrolled diabetes, acute or chronic liver disease, pancreatic, or severe renal disease unrelated to tumor, active or uncontrolled infection).
* Women who are pregnant, breast feeding, or of childbearing potential without a negative serum pregnancy test at baseline. Male or female patients of childbearing potential unwilling to use an effective barrier contraceptive method
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02917720
Study Brief:
Protocol Section:
NCT02917720