drugset / Trial / NCT00121199

Combination Chemo, Rituximab, and Bevacizumab in Older Patients With Stage II-IV Diffuse Large B-Cell Lymphoma

NCT00121199 ↗

Phase 2 Completed 73 enrolled National Cancer Institute (NCI)
NaSingle-groupOpen-labelTreatment

Summary

This phase II trial is studying how well giving combination chemotherapy together with rituximab and bevacizumab works in treating older patients with stage II, stage III, or stage IV diffuse large B-cell lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Monoclonal antibodies, such as rituximab and bevacizumab, 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. Bevacizumab may also stop the growth of cancer cells by blocking blood flow to the cancer. Giving combination chemotherapy together with monoclonal antibodies may kill more cancer cells.

Timeline

Start
2005-06
Primary completion
2010-12
Completion
2010-12

Outcome

Missed primary endpoint

paper These PFS estimates were not statistically different from the expected PFS for this population if treated with R-CHOP alone. PMID 22734071 ↗

paper In conclusion, the addition of bevacizumab to R-CHOP chemotherapy was not promising in terms of PFS PMID 22734071 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody — Intravenous
Background Cyclophosphamide Other / unclassified — Intravenous
Background Doxorubicin Other / unclassified — Intravenous
Background Prednisone Other / unclassified — Oral
Background Rituximab Monoclonal antibody — Intravenous
Background Vincristine Small molecule — Intravenous