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 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT00096018
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Confirmed diagnosis of B-cell chronic lymphocytic leukemia (CLL) based on the following criteria:
* Peripheral blood lymphocytosis \> 5,000/mm\^3
* Co-expression of CD5, CD19 or CD20, and CD23 surface antigens
* Clonal kappa or lambda light chain expression
* No recurrent or refractory CLL
* No other lymphoproliferative diseases or diseases due to transformation of CLL, such as prolymphocytic leukemia or Richter's syndrome
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Karnofsky 60-100%
Life expectancy
* At least 12 weeks
Hematopoietic
* See Disease Characteristics
Hepatic
* Bilirubin \< 1.5 mg/dL
* AST \< 2.5 times upper limit of normal
Renal
* Creatinine ≤ 1.5 mg/dL
Cardiovascular
* No cardiac arrhythmia within the past 6 months
* No myocardial infarction within the past 6 months
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use at least 1 highly active and 1 additional method of contraception for 4 weeks before, during, and for at least 4 weeks after study treatment
* Patients must have sufficient mental capacity to understand the study explanation and provide informed consent
* No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
* No active serious infection uncontrolled by antibiotics
* No medical condition or reason that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* No prior therapy for CLL
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00096018
Study Brief:
Protocol Section:
NCT00096018