Spots Global Cancer Trial Database for Radioimmunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

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Trial Identification

Brief Title: Radioimmunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Official Title: A Multicenter, Open-Label, Trial to Evaluate the Efficacy and Safety of IDEC-Y2B8 Radioimmunotherapy of Relapsed or Refractory Low-Grade or Follicular Transformed B-Cell Non-Hodgkin's Lymphoma

Study ID: NCT00005592

Conditions

Lymphoma

Interventions

90-Y-ibritumomab tiuxetan

rituximab

indium In 111 ibritumomab tiuxetan

Study Description

Brief Summary: RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver radiation to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of rituximab and ibritumomab tiuxetan in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.

Detailed Description: OBJECTIVES: I. Determine the efficacy and safety of rituximab and ibritumomab tiuxetan radioimmunotherapy in patients with refractory or relapsed, low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma. OUTLINE: This is a multicenter study. Patients receive rituximab IV on days 1 and 8 immediately followed by IDEC-In2B8 IV over 10 minutes on day 1. Patients also receive ibritumomab tiuxetan IV over 10 minutes on day 8. Patients are followed every 3 months for 2 years and then every 6 months for 2 years. PROJECTED ACCRUAL: Approximately 400 patients will be accrued for this study.