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 @ 5:45 PM
Ignite Modification Date:
2025-12-24 @ 5:45 PM
NCT ID:
NCT00335868
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of chronic myelogenous leukemia confirmed by bone marrow biopsy
* Chronic, accelerated, or blastic phase disease
* May have T315I mutation in BCR-ABL kinase
* Relapsed after prior imatinib mesylate or c-ABL therapy
* No CNS leukemia
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Blood pressure ≤ 140/90 mm Hg (with or without hypertension treatment for ≥ 1 week)
* Transaminases ≤ 2.5 times upper limit of normal (ULN)
* Bilirubin ≤ 1.5 times ULN
* Creatinine ≤ 1.5 times ULN
* No known history of HIV infection
* No active uncontrolled infection
* No grade 3 or 4 bleeding
* LVEF ≥ 45% by MUGA or ≥ 40% by transthoracic echocardiography
* No medical or psychiatric condition or laboratory abnormalities that would limit study compliance or increase risk during study participation
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 90 (female) or 180 (male) days after completion of study treatment
* No significant cardiovascular disease (i.e., uncontrolled arrhythmias or unstable angina) within the past 6 months
* No major thromboembolic event within the past 6 months, including any of the following:
* Myocardial infarction
* Stroke
* Transient ischemic attack
* Pulmonary embolism
* Noncatheter-related deep-vein thrombosis
PRIOR CONCURRENT THERAPY:
* Recovered from all acute toxic effects (excluding alopecia) of prior therapy
* More than 2 weeks since prior chemoimmunotherapy
* Hydroxyurea must be discontinued 1 day prior to study therapy
* More than 4 weeks since prior major surgery
* No other concurrent approved or investigational anticancer treatment, including chemotherapy, biologic response modifiers, hormones, or immunotherapy
* No other concurrent investigational drugs
* No concurrent participation in another treatment clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00335868
Study Brief:
Protocol Section:
NCT00335868