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 @ 4:03 AM
Ignite Modification Date:
2025-12-25 @ 4:03 AM
NCT ID:
NCT00025402
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of chronic myelogenous leukemia in chronic phase
* Previously untreated
* Patients negative for Philadelphia chromosome and BCR-ABL translocation must fulfill at least 1 of the following criteria:
* Impaired health status with reduced exercise tolerance
* Spleen-related symptoms in cases of splenomegaly
* Weight loss greater than 10% in 6 months
* Fever greater than 38.5 degrees C on 5 consecutive days
* Clinically relevant bone pain
* Leukocytosis greater than 5,000/mm\^3
* Thrombocytosis greater than 100,000/mm\^3
PATIENT CHARACTERISTICS:
Age:
* Any age
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* See Disease Characteristics
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* No other concurrent malignancy that is likely to require treatment during study or that is likely to reduce life expectancy
* No severe concurrent disease or other cause that would preclude study
* Not pregnant
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior interferon
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy
Surgery:
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00025402
Study Brief:
Protocol Section:
NCT00025402