drugset / Trial / NCT00397800

Rituximab, Fludarabine, Cyclophosphamide, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Relapsed B-Cell Non-Hodgkin's Lymphoma

NCT00397800

Phase 1/2 Unknown 12 enrolled Technical University of Munich
Non-randomizedOpen-labelTreatment

Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Giving rituximab and chemotherapy together with yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of yttrium Y 90 ibritumomab tiuxetan when given together with rituximab, fludarabine, and cyclophosphamide and to see how well they work in treating patients with relapsed B-cell non-Hodgkin's lymphoma.

Timeline

Start
2005-06
Primary completion
2008-05
Completion
2013-05

Drugs

EvaluationDrugModalityDoseRoute
Subject 90Y-ibritumomab tiuxetan Other / unclassified Intravenous
Subject Cyclophosphamide Other / unclassified Intravenous
Subject Fludarabine Small molecule Intravenous
Subject Rituximab Monoclonal antibody Intravenous

Indications