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 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT00251394
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older
* Pathological evidence of CD20+, B-cell follicular non-Hodgkin's lymphoma
* Received at least one previous chemotherapy regimen for lymphoma
* Hemoglobin \> 8.5 g/dl
* WBC \> 2,000/mm3
* ANC \> 1,000/mm3
* Platelet count \> 75,000/mm3
* ECOG performance status of less than or equal to 2
* Life expectancy of greater than 4 months
* Women and men of childbearing potential must be willing to use highly effective methods of birth control for duration of time on the study
Exclusion Criteria:
* Pregnant of lactating women
* Treatment with chemotherapy, including systemic steroids, or radiation therapy within 30 days
* Current use of systemic or inhaled steroids
* Treatment with radioimmunotherapy, autologous stem cell transplantation, or fludarabine within 6 months
* Disease progression within 6 months of any previous rituximab therapy
* History of allogenic transplantation, including nonmyeloablative transplantation
* Unstable angina, symptomatic cardiac arrhythmia or clinical heart failure
* Severe pulmonary disease, symptomatic pleural effusions, or clinically significant pulmonary symptoms
* Active infection requiring systemic antibiotic, antiviral, or antifungal therapy
* Clinically apparent CNS lymphoma
* Major surgery within 2 weeks
* Known human anti-murine antibody (HAMA) or human anti-chimeric antibody (HACA) response
* Known Hepatitis B surface antigen positive
* History of autoimmune disorder
* Current therapeutic use of anticoagulants
* History of coagulopathy
* Known allergy to any of the components of 1018 ISS or Rituxan
* Participation in another investigational trial within 30 days
* Any clinically significant abnormality in screening blood chemistry, hematology, or urinalysis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00251394
Study Brief:
Protocol Section:
NCT00251394