drugset / Trial / NCT00003595

Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Previously Untreated HIV-Associated Non-Hodgkin's Lymphoma

NCT00003595 ↗

Phase 3 Completed 120 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupOpen-labelTreatment

Summary

Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without monoclonal antibody therapy in treating patients who have previously untreated HIV-associated non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy plus monoclonal antibody therapy is more effective than combination chemotherapy alone in treating HIV-associated non-Hodgkin's lymphoma.

Timeline

Start
1999-01
Primary completion
2006-04
Completion
—

Outcome

Missed primary endpoint

paper The complete response rate (CR + CRu) was 57.6% for R-CHOP and 47% for CHOP (P = .147). PMID 15914552 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Background Cyclophosphamide Other / unclassified — Intravenous
Background Doxorubicin Other / unclassified — Intravenous
Background Prednisone Other / unclassified — Oral
Background Vincristine Small molecule — Intravenous
Background filgrastim Protein / enzyme biologic — Subcutaneous

Indications