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 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT00436904
Eligibility Criteria:
DISEASE CHARACTERISTICS:
\* Diagnosis of B-cell chronic lymphocytic leukemia (CLL)
\- Early-stage, biologically high-risk disease defined by the following criteria:
* Rai stage 0-II (does not meet standard NCI-sponsored Working Group criteria for treatment)
* Clinical and phenotypic features manifested in the peripheral blood, including the following:
* Minimum threshold peripheral blood lymphocyte count of \> 5,000/mm³
* Small-to-moderate peripheral blood lymphocytes with ≤ 55% prolymphocytes
* Monoclonality of B lymphocytes by immunophenotypic evaluation, demonstrating co-expression of CD19, CD5, and CD23 antigens, surface expression of CD20 and CD52, and B-cell monoclonal population defined by light-chain exclusions
* Poor prognosis demonstrated by ≥ 1 of the following high-risk parameters:
* Unmutated human immunoglobulin variable region heavy chain (IgVH) gene and CD38 expression (≥ 30% cells positive on flow cytometry) OR unmutated IgVH ZAP-70 expression (≥ 20% cells positive on flow cytometry) = 11q- = 17p-
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Creatinine ≤ 1.5 times upper limit of normal (ULN)
* Total bilirubin ≤ 3.0 times ULN OR direct bilirubin ≤ 1.5 times ULN
* AST ≤ 3.0 times ULN (unless due to hemolysis or CLL)
* Hemoglobin ≥ 9.0 g/dL
* No New York Heart Association class III-IV heart disease
* No myocardial infarction within the past month
* No uncontrolled infection
* No active HIV infection
* No evidence of autoimmune hemolytic anemia, immune thrombocytopenia, or pure red blood cell aplasia
* No other active primary malignancy requiring treatment or limiting survival to less than 2 years
PRIOR CONCURRENT THERAPY:
* No prior treatment for CLL
* Prior corticosteroids allowed
* No prior radiotherapy
* More than 4 weeks since prior major surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00436904
Study Brief:
Protocol Section:
NCT00436904