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 @ 3:22 PM
Ignite Modification Date:
2025-12-24 @ 3:22 PM
NCT ID:
NCT01096992
Eligibility Criteria:
Inclusion Criteria:
1. Patients must have a diagnosis of CLL/Small Lymphocytic Lymphoma (SLL) and be previously treated
2. Patients must have an indication for treatment by 2008 IWCLL Criteria
3. Age \>/= 16 years
4. Zubrod performance status \</= 2
5. Adequate renal and hepatic function as indicated by all the following: a. serum creatinine \</= 2 mg/dL AND; b. alanine aminotransferase (ALT) \</= 2.5 times upper limit of normal AND; c. total bilirubin \</= 2.5 times upper limit of normal
6. Patients must give written informed consent
7. Patients of childbearing potential must be willing to practice birth control during the study
Exclusion Criteria:
1. Pregnant or breast-feeding females
2. Significant co-morbidity indicated by major organ system dysfunction
3. Active, uncontrolled infection, including active hepatitis
4. Uncontrolled autoimmune hemolytic anemia (AIHA) or immune thrombocytopenia purpura (ITP)
5. Treatment including chemotherapy, chemoimmunotherapy, monoclonal antibody therapy, radiotherapy, high-dose corticosteroid therapy (Prednisone \>/ 60 mg daily or equivalent), or immunotherapy within 21 days prior to enrollment or concurrent with this trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT01096992
Study Brief:
Protocol Section:
NCT01096992