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 @ 7:48 PM
Ignite Modification Date:
2025-12-24 @ 7:48 PM
NCT ID:
NCT00714103
Eligibility Criteria:
Inclusion Criteria:
1. Patients must have a diagnosis of chronic lymphocytic leukemia and must be previously treated with at least one prior treatment regimen, including a purine-analogue based treatment.
2. Patients must be Rai Stage III or IV OR Rai Stage 0-II and have one or more criteria for active disease as defined by the NCI-Working Group as: a) weight loss of more than 10% in the last 6 months; b) fatigue; c) fever or night sweats without evidence of infection; d) progressive anemia or thrombocytopenia; e) progressive lymphocytosis with a lymphocyte doubling time \</= 6 months; or f) marked hypogammaglobulinemia or paraproteinemia.
3. All patients must have a Zubrod performance status of \</= 2.
4. All patients must be age \>/= 18 years.
5. Patients may not receive concurrent treatment for their CLL and must have been off treatment (chemotherapy, immunotherapy, or radiotherapy) for 4 weeks prior to treatment on this study and recovered from toxic effects of that therapy.
6. All patients must have adequate renal function indicated by serum creatinine \</=2.5x upper limits of normal (ULN) and adequate liver function indicated by ALT or AST \</= 2.5x ULN AND total bilirubin \</= 2.5x ULN.
7. All patients must have a pre-treatment platelet count of \>/= 50,000 /µl and not require transfusion to maintain this platelet count unless thrombocytopenia is due to marrow infiltrated with disease.
8. All patients or appropriate surrogate must provide informed consent.
Exclusion Criteria:
1. Patients with active uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia purpura.
2. Patients with active uncontrolled fungal, bacterial, or viral infection.
3. Patients who are pregnant or breast-feeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00714103
Study Brief:
Protocol Section:
NCT00714103