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 @ 4:55 AM
Ignite Modification Date:
2025-12-25 @ 4:55 AM
NCT ID:
NCT00366418
Eligibility Criteria:
* INCLUSION CRITERIA
* Patients diagnosed with Chronic Lymphocytic Leukemia
* Prior therapy with fludarabine or a fludarabine containing regimen
* CD20 expression on CLL cells
* Neutrophil count ANC greater than 500/mm(3)
* Platelet count greater than 30K/mm(3)
* Age 21-99
EXCLUSION CRITERIA
* Bulky lymphadenopathy, defined as greater than 1 lymph node with greater than 5cm in largest diameter
* Evidence for transformation into high grade lymphoma (Richter's transformation)
* ECOG performance 3 or higher
* Other concurrent anticancer therapies
* Less than 3 months from last systemic therapy for CLL
* Less than 6 months from last monoclonal antibody therapy
* More than 10 doses rituximab, within 12 months preceeding protocol enrollment, either as single agent or in a combination chemotherapy regimen
* Chronic or current clinically significant infection, including HIV positivity or hepatitis C
* Moribund status or concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious, or metabolic disease of such severity that it would preclude the patient's ability to tolerate protocol therapy
* History of mucocutaneous reactions (paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis)
* Known anaphylaxis or IgE mediated hypersensitivity to murine proteins or to any component of this product
* Inability to self inject the study medication or to have it administered by a third person
* Inability to understand the investigational nature of the study ability to provide informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
99 Years
Study:
NCT00366418
Study Brief:
Protocol Section:
NCT00366418