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 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT01253460
Eligibility Criteria:
Inclusion Criteria:
1. Patients must have a diagnosis of CLL/SLL and be previously treated
2. Patients must have had Fluorescence in situ Hybridization (FISH) evaluation of leukemia cells within 3 months without intervening treatment demonstrating deletion 11q22-23
3. Patients must have an indication for treatment by 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria
4. Age \>/= 18 years
5. Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status \</= 2
6. Adequate renal and hepatic function as indicated by all the following: serum creatinine \</= 2 mg/dL AND; alanine aminotransferase (ALT) \</= 2.5 times upper limit of normal; AND total bilirubin \</= 2.5 times upper limit of normal
7. Patients must have an Absolute neutrophil count (ANC) \>/= 500/uL, Hemoglobin (HGB) \>/= 8 gm/dL, Platelets (PLT) count \>/= 20K/uL, unless attributed to marrow infiltration with CLL
8. Patients must give written informed consent
9. Patients of childbearing potential (females who have not been postmenopausal for at least 12 consecutive months or who have not undergone previous surgical sterilization or males who have not been surgically sterilized) 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 infection, uncontrolled with intravenous antibiotics
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 3 weeks prior to enrollment or concurrent with this trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01253460
Study Brief:
Protocol Section:
NCT01253460