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 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT00812669
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of chronic lymphocytic leukemia
* Stage I-IV disease (Binet stage progressive A, B, C)
* CD5 and CD23 positive
* Untreated OR relapsed/resistant disease after combination chemotherapy or rituximab
* No 17p deletion
PATIENT CHARACTERISTICS:
* WHO performance status 0-2
* Life expectancy \> 1 year
* Creatinine clearance ≥ 50 mL/min
* HIV negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other concurrent malignancy except for noninvasive cervical cancer or localized nonmelanomatous skin cancer
* No history of anaphylaxis to mouse-derived humanized monoclonal antibody
* No other severe concurrent (e.g., cardiac or pulmonary) diseases or mental disorders that could interfere with ability to participate in the study
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Years
Maximum Age:
64 Years
Study:
NCT00812669
Study Brief:
Protocol Section:
NCT00812669