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 @ 9:45 PM
Ignite Modification Date:
2025-12-24 @ 9:45 PM
NCT ID:
NCT00496132
Eligibility Criteria:
Inclusion Criteria:
* Documented history of histologically confirmed B-cell CLL
* Relapsed or refractory CLL with history of prior treatment with purine nucleoside analogue-containing regimen
* Eligible for treatment of their CLL based on criteria adapted from the National Cancer Institute-Working Group (NCI-WG) Response Criteria for CLL
* For patients of reproductive potential (males and females), use of a reliable means of contraception
* For females of childbearing potential, a negative serum pregnancy test
Exclusion Criteria:
* Prior use of anti-CD20 monoclonal antibody therapy (other than rituximab)
* Prior use of any non-CD20 targeted monoclonal antibody therapy within 6 months of enrollment
* Current or recent CLL treatment
* History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies
* Evidence of acute/active autoimmune hemolytic anemia or other autoimmune complications of CLL
* Use of hematopoietic growth factors or RBC and/or platelet transfusions
* Evidence of significant uncontrolled concomitant diseases, such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders
* Evidence of myelodysplasia or myelodysplastic changes on bone marrow examination
* History of cancer other than CLL)
* Known active bacterial, viral, fungal, mycobacterial, or other infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics or oral antibiotics
* A major episode of infection requiring hospitalization or treatment with IV antimicrobials within 4 weeks of screening or oral antimicrobials within 2 weeks of screening
* Positive hepatitis B or C serology
* Positive human immunodeficiency virus (HIV) serology
* Active cytomegalovirus (CMV) disease by antigen or polymerase chain reaction testing
* Pregnancy or lactation
* CNS leukemia
* Recent major surgery, other than diagnostic surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00496132
Study Brief:
Protocol Section:
NCT00496132