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 @ 11:53 AM
Ignite Modification Date:
2025-12-24 @ 11:53 AM
NCT ID:
NCT01013961
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of chronic lymphocytic leukemia (CLL) meeting the following criteria:
* Minimum threshold peripheral lymphocyte count of 5 x 10\^9/L (CLL variant) OR palpable adenopathy \> 1 cm or palpable splenomegaly 9small lymphocytic lymphoma \[SLL\] 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 immunoglobulin heavy chain/cyclin D1 gene (IGH/CCND1) and/or immunostaining is negative for cyclin D1 expression (to exclude mantle cell lymphoma)
* Progressive, symptomatic CLL, defined by at least one of the following:
* Weight loss \> 10% within the past 6 months attributable to progressive CLL (grade 2 or higher)
* Extreme fatigue attributable to progressive CLL (grade 3 or higher)
* Fevers \> 100.5° F for 2 weeks without evidence of infection (grade 1 or higher)
* Night sweats without evidence of infection (drenching)
* Evidence of progressive bone marrow failure with hemoglobin \< 11 g/dL or platelet count \< 100 x 10\^9/L
* Rapidly progressive lymphadenopathy for which the largest node is ≤ 5 cm in any dimension
* Largest lymph nodes involved in the neck, axilla, and groin need to be measured and followed for response
Exclusion Criteria:
* Prior treatment for CLL
* Massive splenomegaly \> 6 cm below left costal margin, at rest, on clinical examination
* Lymphadenopathy \> 5 cm in any diameter
* New York Heart Association class III or IV heart disease
* Recent myocardial infarction (within the past month)
* Uncontrolled infection
* Infection with the human immunodeficiency virus (HIV/AIDS)
* Serological evidence of active hepatitis B infection (HBsAg or HBeAg positive)
* Positive hepatitis C serology
* Evidence of active autoimmune hemolytic anemia, immune thrombocytopenia, or pure red blood cell aplasia
* Other active primary malignancy requiring treatment or that limits survival to ≤ 2 years, except for in situ carcinoma of the cervix or breast or non-metastatic basal cell or squamous cell carcinoma of the skin
* Major surgery within 4 weeks prior to pre-registration
* Concomitant use of continuous systemic corticosteroids
* Prior corticosteroids are allowed but not at time of pre-registration to the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT01013961
Study Brief:
Protocol Section:
NCT01013961