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 @ 4:32 AM
Ignite Modification Date:
2025-12-25 @ 4:32 AM
NCT ID:
NCT00669318
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) meeting the following criteria:
* Minimum threshold peripheral blood lymphocyte count of 5 x 10\^9/L (CLL variant) OR adenopathy \> 1 cm or palpable splenomegaly (SLL variant)
* Immunophenotypic demonstrations of a population of B lymphocytes (as defined by CD19+) that are monoclonal (by light chain exclusion) AND have ≥ 3 of the following characteristics:
* CD5+
* CD23+
* Dim surface light chain expression
* Dim surface CD20 expression
* FISH analysis is negative for IGH/CCND1 and/or immunostaining is negative for cyclin D1 expression
* Must have progressive disease as indicated by any of the following characteristics (based on standard criteria for treatment):
* Symptomatic CLL characterized by any of the following:
* Weight loss \> 10% within the past 6 months
* Extreme fatigue
* Fevers \> 38.5° C (not due to infection)
* Drenching night sweats without evidence of infection
* Evidence of progressive bone marrow failure with hemoglobin \< 11 g/dL or platelet count \< 100 x 10\^9/L
* Massive and progressive splenomegaly (\> 6 cm below left costal margin)
* Massive (\> 10 cm) or rapidly progressive lymphadenopathy
PATIENT CHARACTERISTICS:
* ECOG performance status 0-3
* Creatinine ≤ 2 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)
* Willing to provide mandatory blood samples for research studies
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for up to 12 months after completion of study treatment
* No other active primary malignancy that requires treatment or limits survival to ≤ 2 years
* No active autoimmune hemolytic anemia, immune thrombocytopenia, or pure red blood cell aplasia
* No New York Heart Association class III or IV heart disease
* No myocardial infarction within the past month
* No uncontrolled infection
* No HIV infection or AIDS
* No active hepatitis B infection (i.e., HBsAg or HBeAg positivity) or hepatitis C infection by serology
* No other comorbid condition
PRIOR CONCURRENT THERAPY:
* No more than 3 prior treatment regimens for CLL that included purine analogue drugs (e.g., fludarabine, pentostatin, or cladribine) OR previously untreated CLL in patients with high-risk disease due to 17p13 deletion on FISH analysis
* More than 4 weeks since prior major surgery
* More than 2 months since prior alemtuzumab
* Prior corticosteroids allowed
* No concurrent continuous systemic corticosteroids
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00669318
Study Brief:
Protocol Section:
NCT00669318