Study of Dynavax's 1018 ISS, Following Rituxan in Patients With B-Cell Follicular Lymphoma
Non-Hodgkin's Lymphoma
About this trial
This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring B-Cell follicular non-Hodgkin's lymphoma, Rituxan, Rituximab, 1018 ISS, CD 20 +
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
Sites / Locations
- Massachusetts General Hospital
- Brigham and Women's Hospital
- Dana-Farber Cancer Institute