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 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
NCT ID:
NCT00281892
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of chronic lymphocytic leukemia (CLL) meeting 1 of the following criteria:
* Previously untreated disease
* Progressive or relapsed CLL after treatment with nonpurine analog-containing regimens as chlorambucil or bendamustine hydrochloride
* Meets 1 of the following staging criteria:
* Binet stage A disease with B symptoms requiring treatment
* Binet stage B disease requiring treatment, meeting ≥ 1 of the following criteria:
* Rapid disease progression
* Enlarged lymph nodes and organs
* Severe B symptoms
* Binet stage C disease
* Must have comorbidities (i.e., CIRS score \> 6)
* Must have restricted kidney function (i.e., creatinine clearance \< 70mL/min)
* No transformation to aggressive non-Hodgkin's lymphoma (Richter's syndrome)
PATIENT CHARACTERISTICS:
* Life expectancy \> 6 months
* Creatinine clearance \> 30 mL/min
* No active second malignancy
* No active bacterial, viral, or fungal infection
* No conditions that would preclude substitution of iron
* No severe myocardial, coronary, or respiratory insufficiency
* No severe liver insufficiency
* No known hypersensitivity to darbepoetin alfa
* No cerebral dysfunction that would preclude participation in the required study procedures
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No concurrent participation in another clinical trial
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00281892
Study Brief:
Protocol Section:
NCT00281892