drugset / Trial / NCT00295932

Bortezomib, Rituximab, Cyclophosphamide, and Prednisone in Treating Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma

NCT00295932

RandomizedParallel-groupOpen-labelTreatment

Summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. 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. Giving bortezomib together with cyclophosphamide, prednisone, and rituximab may be an effective treatment for non-Hodgkin's lymphoma. PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of bortezomib when given together with cyclophosphamide, prednisone, and rituximab and to see how well it works in treating patients with relapsed or refractory indolent B-cell non-Hodgkin's lymphoma.

Timeline

Start
2005-12-13
Primary completion
2018-03-11
Completion
2018-03-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule Intravenous
Subject Cyclophosphamide Other / unclassified 750 mg/m2 Intravenous
Subject Cyclophosphamide Other / unclassified 1000 mg/m2 Intravenous
Background Prednisone Other / unclassified 100 mg Oral
Background Rituximab Monoclonal antibody 375 mg/m2 Intravenous

Indications