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 @ 2:45 PM
Ignite Modification Date:
2025-12-24 @ 2:45 PM
NCT ID:
NCT02317159
Eligibility Criteria:
Inclusion Criteria:
* Age≥18；
* The new diagnosis of CML patients in six months；
* No proof of extra-medullary infiltration of leukemia；
* ECOG PS score：0-2；
* Hepatic and renal functions are normal，Serum bilirubin≤1.5\*ULN, serum ALT and AST≤2.5\*ULN, serum Cr≤1.5\*ULN;
* Do not receive the treatment of anti-CML；
* Subjects signed informed consent form in line with GCP requirements。
Exclusion Criteria:
* Pregnant or lactating women；
* Received TKIs any time before；
* Failure to control systemic infection or multiple organ failure；
* According to the investigator's judgment, there are concomitant diseases with a serious safety hazard or affect the patients completed the study；
* Being diagnosed with other malignancies in the prior 12 months；
* Have a history of neurological or psychiatric disorders, including epilepsy or dementia；
* Known or suspected allergy to imatinib；
* BSA≤1.5m2；
* Using other experimental drugs or participating in other clinical trials in the prior one months。
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02317159
Study Brief:
Protocol Section:
NCT02317159