Tositumomab And Iodine I 131-Tositumomab In Patients With Relapsed Indolent Non-Hodgkin's Lymphoma
Lymphoma, Non-Hodgkin
About this trial
This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring BEXXAR, non-Hodgkin's Lymphoma, tositumomab, I-131
Eligibility Criteria
Inclusion criteria: Patients must have evidence of persistent or progressive follicular grade, 1, 2 or 3 or marginal zone B-cell non-Hodgkin's lymphoma. Must have received at least two prior courses of systemic treatment including at least one treatment of rituximab (lymphoma must not have progressed during their most recent systemic chemotherapy treatment). Must have evidence that their lymphoma expresses CD20 antigen and have adequate renal and hepatic function. Exclusion criteria: Received chemotherapy, radiation therapy, immunosuppressants or cytokine treatment within 4 weeks prior to study entry. Have active obstructive hydronephrosis. Had prior autologous hematopoietic stem cell transplant or any allogenic stem cell transplant. Have active infection requiring IV antibiotics. Have brain or leptomeningeal metastasis. Had previous allergic reaction to iodine, previously received radioimmunotherapy or are currently receiving approved or experimental anti-cancer drugs. Patients who are pregnant or breast feeding, have known HIV infection, or are Human anti-murine antibody (HAMA) positive. Other criteria will be evaluated at the screening visit.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Experimental
Arm 1
Participants underwent two phases of treatment: an initial DD, followed by a therapeutic dose. The one-day DD comprised a 1 hr IV infusion of 450 mg unlabeled TST, followed by a 20 min IV infusion of 35 mg TST labeled with 185 MBq (5.0 mCi) of I 131. After 7 to 14 days, the one-day therapeutic dose comprised a second 1 hr IV infusion of 450 mg unlabeled TST, followed by a 20 min IV infusion of 35 mg TST labeled with I 131 with an administered activity (MBq or mCi) determined from the dosimetry calculation.