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 @ 5:19 PM
Ignite Modification Date:
2025-12-24 @ 5:19 PM
NCT ID:
NCT00419250
Eligibility Criteria:
Inclusion Criteria:
* Documented diagnosis of B-cell CLL that has relapsed after or is refractory to at least one prior regimen. The prior regimen(s) must have included an alkylating agent and fludarabine (used in combination or separately)
* ECOG \< or = 2
* Willing to agree to follow the pregnancy precautions.
Exclusion Criteria:
* Pregnant or nursing women
* Systemic treatment for B-cell CLL within 28 days of study start
* Central nervous system involvement
* History of renal failure requiring dialysis
* Prior treatment with lenalidomide
* Alemtuzumab therapy within 56 days of initiating lenalidomide treatment
* ANC \< 1000 / ul
* Platelet count \< 50,000 / ul
* Calculated creatinine clearance \< 60 mL/min (Cockroft-Gault method)
* AST or ALT \> 3.0 x upper limit of normal
* Serum total bilirubin \> 2.0 mg/dl
* Neuropathy \> or = Grade 2
* Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
* Richter's transformation (active)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00419250
Study Brief:
Protocol Section:
NCT00419250