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 @ 2:04 PM
Ignite Modification Date:
2025-12-24 @ 2:04 PM
NCT ID:
NCT00816595
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of 1 of the following:
* Biopsy proven small lymphocytic lymphoma (SLL)
* Chronic lymphocytic leukemia (CLL)\* as evidenced by the following criteria:
* Peripheral blood lymphocyte count \> 5,000/mm³ consisting of small to moderate size lymphocytes
* Immunophenotyping consistent with CLL, defined by the following:
* The predominant population of lymphocytes share both B-cell antigens (CD19, CD20, or CD23) as well as CD-5 in the absence of other pan-T-cell markers (CD-3 or CD-2)
* Dim surface immunoglobulin expression
* Exclusively kappa and lambda light chains
* Negative FISH analysis for t(11;14)(IgH/CCND1) on peripheral blood or tissue biopsy samples NOTE: \*Splenomegaly, hepatomegaly, or lymphadenopathy are not required for the diagnosis of CLL
* Has ≥ 1 of the following indications\*\* for chemotherapy:
* Evidence of progressive marrow failure as manifested by the development of or worsening anemia (hemoglobin ≤ 11 g/dL) and/or thrombocytopenia (platelet count ≤ 100,000/mm³)
* Symptomatic or progressive lymphadenopathy, splenomegaly or hepatomegaly
* Has ≥ 1 of the following disease-related symptoms:
* Weight loss \> 10% within the past 6 months
* Extreme fatigue attributed to CLL
* Fevers \> 100.5\^oF for 2 weeks without evidence of infection
* Night sweats without evidence of infection
* Progressive lymphocytosis (not due to the effects of corticosteroids) with an increase of \> 50% over a 2-month period or an anticipated doubling time of \< 6 months NOTE: \*\*Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease are not sufficient indications for study treatment
PATIENT CHARACTERISTICS:
* Eastern Cooperative Oncology Group performance status 0-3
* Life expectancy ≥ 12 months
* Total bilirubin ≤ 3.0 times upper limit of normal (ULN) (unless due to Gilbert's disease)
* Direct bilirubin \< 1.5 mg/dL (in patients with Gilbert's disease)
* Serum glutamate oxaloacetate transaminase ≤ 3.0 times ULN (unless due to hepatic involvement by CLL)
* Creatinine ≤ 1.5 times ULN
* Urine protein:creatinine ratio \< 1.0 OR \< 1 g of protein by 24-hour urine collection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 12 months after completion of study treatment
* Willing to provide mandatory blood and tissue samples
* None of the following cardiovascular conditions:
* NYHA class III-IV heart disease
* Myocardial infarction within the past 6 months
* Unstable angina
* Stroke, cerebrovascular accident, or transient ischemic attack within the past 6 months
* Arterial thromboembolic events within the past 12 months
* Clinically significant peripheral vascular disease
* Uncontrolled hypertension, defined as systolic BP \> 150 mm Hg or diastolic BP \> 100 mm Hg
* Hypertension allowed provided it is controlled with a stable anti-hypertensive regimen
* History of hypertensive crises or hypertensive encephalopathy
* Deep venous thromboses or pulmonary embolism within the past 12 months
* No evidence of bleeding diathesis or coagulopathy
* No uncontrolled or active hemolytic anemia requiring immunosuppressive therapy or other pharmacologic treatment
* No active or recent history (within the past 30 days) of hemoptysis (≥ ½ teaspoon of bright red blood per episode)
* No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
* No active peptic ulcer disease
* No serious non-healing wound, ulcer, or bone fracture
* No significant traumatic injury within the past 28 days
* No uncontrolled infection
* No active HIV infection
* No other active primary malignancy (except nonmelanoma skin cancer or carcinoma in situ of the cervix) requiring treatment or limiting survival to ≤ 2 years
* No psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude study participation
PRIOR CONCURRENT THERAPY:
* Prior corticosteroids allowed
* More than 4 weeks since prior radiotherapy
* More than 28 days since prior and no concurrent major surgical procedure or open biopsy
* More than 7 days since prior minor surgical procedure, fine needle aspiration, or core biopsy (other than bone marrow biopsy)
* No concurrent therapeutic doses of coumadin-derivative anticoagulants (e.g., warfarin)
* Doses of ≤ 2 mg daily allowed for prophylaxis of thrombosis
* Prophylactic doses of low molecular weight heparin allowed
* No other concurrent investigational agents for treatment of CLL or SLL
* No other concurrent specific anticancer treatment except hormonal therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00816595
Study Brief:
Protocol Section:
NCT00816595