drugset / Trial / NCT00049036

Combination Chemotherapy and Rituximab in Treating Patients With HIV-Associated Stage I, Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma

NCT00049036 ↗

Phase 2 Completed 106 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized phase II trial is studying how well giving combination chemotherapy together with rituximab works in treating patients with HIV-associated stage I, stage II, stage III, or stage IV non-Hodgkin's lymphoma. Drugs used in chemotherapy work in 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. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells.

Timeline

Start
2003-03
Primary completion
2009-05
Completion
2009-05

Outcome

Mixed primary results

paper The primary efficacy endpoint was met for the concurrent arm only. PMID 20023215 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Background Cyclophosphamide Other / unclassified — Intravenous
Background Doxorubicin Other / unclassified — Intravenous
Background Etoposide Small molecule — Intravenous
Background Prednisone Other / unclassified — Oral
Background Vincristine Small molecule — Intravenous