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 @ 7:24 PM
Ignite Modification Date:
2025-12-24 @ 7:24 PM
NCT ID:
NCT00482703
Eligibility Criteria:
Inclusion Criteria:
* Philadelphia chromosome positive or bcr-abl gene positive Chronic phase Chronic Myelogenous Leukemia (CML) subjects must have primary or acquired resistance to Imatinib mesylate or have intolerance of imatinib mesylate
* Performance status (general conditions) specified by the Eastern Cooperative Oncology Group: 0-2
* Men and women, ages 20 to 75
* Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 3 months after the study in such a manner that the risk of pregnancy is minimized
Exclusion Criteria:
* Subjects who are eligible and willing to undergo transplantation at pre-study
* Women who are pregnant or breastfeeding
* Uncontrolled or significant cardiovascular disease
* History of significant bleeding disorder unrelated to CML
* Adequate hepatic function
* Adequate renal function
* Medication that increases bleeding risk
* Medication that changes heart rhythms
* Subjects who are compulsory detained for legal reasons or treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT00482703
Study Brief:
Protocol Section:
NCT00482703