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 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT00524667
Eligibility Criteria:
Inclusion Criteria:
* Active CLL (as defined by the National Cancer Institute Working Group)
* Patients must have received at least one prior therapy for CLL and have been treated with a nucleoside analogue.
* Recruitment will be limited to those with an ECOG performance status of 2 or less.
Exclusion Criteria:
* Patients who are pregnant or breastfeeding
* Patients with a history of autoimmune cytopenias
* Patients with platelets \< 50 x 109/L or an absolute neutrophil count \< 1.5X109/L
* Patients with hepatic disease or an AST/ALT 6x above the upper limit of normal
* Patients with a calculated creatinine clearance \< 30 ml/min using the Cockroft and Gault formula
* Patients with a history of pancreatitis
* Patients who are receiving drugs that affect VPA protein binding or metabolism
* Patients with active infection, HIV or active viral hepatitis
* Patients with active secondary malignancy or who have central nervous system involvement with CLL
* Patients diagnosed with more an aggressive lymphoproliferative disorder such as Richter's transformation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00524667
Study Brief:
Protocol Section:
NCT00524667