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 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT00517218
Eligibility Criteria:
Inclusion Criteria:
* Previously untreated subjects with intermediate-or high-risk CLL(modified Rai Stages I-IV)
* Measurable disease as primarily established by the National Cancer Institute-sponsored Working Group(NCI-WG) Guidelines for the diagnosis of CLL
* Requiring therapy for active disease, as primarily defined by the NCI-WG Guidelines
* Eastern Cooperative Oncology Group Performance Status \< 2
* Adequate organ function determined , 14 days prior to the first dose of study medication
Exclusion Criteria:
* Absolute Lymphocyte count \> 100,000/uL
* Prior chemotherapy or other therapy for CLL, including allogeneic transplant
* Less than 3 weeks from any prior major surgery at the time of informed consent
* Failure to recover from any serious adverse effect of surgery
* History of autoimmune hemolytic anemia or autoimmune thrombocytopenia
* Active serious infection requiring systemic anti-infective therapy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00517218
Study Brief:
Protocol Section:
NCT00517218