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 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT00541034
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of chronic lymphocytic leukemia (CLL), as evidenced by an absolute lymphocytosis in the blood of at least 5,000 lymphocytes per microliter OR bone marrow lymphocytosis ≥ 30% of all nucleated cells
* Previously untreated disease
* Meets 1 of the following risk criteria as defined by the three-stage Rai system
* Intermediate-risk disease
* Must meet the criteria for active disease as defined by the NCI Working Group guidelines including the following:
* Weight loss
* Fatigue
* Fevers
* Evidence of progressive marrow failure
* Splenomegaly
* Progressive lymphadenopathy
* Progressive lymphocytosis with a rapid doubling time
* High-risk disease
* Malignant lymphocytes must demonstrate B-cells via immunophenotypic or immunohistochemical analysis
* Patients with small lymphocytic lymphoma (CLL type) are eligible
PATIENT CHARACTERISTICS:
Inclusion criteria:
* Karnofsky performance status 60-100%
* Total bilirubin ≤ 2.0 mg/dL (patients with Gilbert disease or autoimmune hemolytic anemia should have an evaluation for other causes of hyperbilirubinemia, but if none are found they may be enrolled regardless of serum bilirubin)
* Total creatinine ≤ 2.0 mg/dL OR creatinine clearance \> 50 mL/min
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Patients with autoimmune hemolytic anemia or autoimmune thrombocytopenia are eligible for treatment on this protocol regardless of disease stage
Exclusion criteria:
* Significant active infections
* Ongoing hepatitis B infection, specifically hepatitis B antigen or surface antigen positivity
* Patients who are hepatitis B antibody positive are eligible for this protocol
PRIOR CONCURRENT THERAPY:
* Concurrent prednisone allowed provided it is used as brief courses (≤ 7 days) for inflammatory conditions unrelated to CLL
* No prior cytotoxic therapy or rituximab for this cancer
* No concurrent radiotherapy or other chemotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00541034
Study Brief:
Protocol Section:
NCT00541034