drugset / Trial / NCT00433537

Combination Chemotherapy and Rituximab in Treating Patients With Untreated Mantle Cell Lymphoma

NCT00433537 ↗

Phase 2 Completed 77 enrolled National Cancer Institute (NCI)
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This phase II trial is studying how well giving rituximab together with combination chemotherapy and bortezomib works in treating patients with untreated mantle cell lymphoma. 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 cyclophosphamide, doxorubicin, vincristine, and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving rituximab together with combination chemotherapy and bortezomib may kill more cancer cells. Treatment consists of six agents: bortezomib (Vc), rituximab (R), cyclophosphamide (C), vincristine (V), doxorubicin (A), and dexamethasone (D) (VcR-CVAD).

Timeline

Start
2007-05
Primary completion
2013-06
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule 1.3 mg/m2 Intravenous
Subject Cyclophosphamide Other / unclassified 300 mg/m2 Intravenous
Subject Dexamethasone Small molecule 40 mg Intravenous
Subject Doxorubicin Other / unclassified 25 mg/m2 Intravenous
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Subject Vincristine Small molecule 1 mg Intravenous
Background Pegfilgrastim Protein / enzyme biologic — Subcutaneous
Background filgrastim Protein / enzyme biologic — Subcutaneous

Indications