drugset / Trial / NCT00216164

Rituximab and Gemcitabine for Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

NCT00216164 ↗

Non-randomizedSingle-groupOpen-labelTreatment

Summary

Rituximab has been demonstrated to sensitize drug-resistant NHL cells to the cytotoxic actions of several chemotherapy agents by enhancing sensitivity of tumor cells to chemotherapy-induced apoptosis. Gemcitabine, a nucleoside analog that is used in several other malignancies, has shown very promising activity in patients with refractory Hodgkin's disease and low-grade NHL. The combination of rituximab and gemcitabine may have synergistic cytotoxic action in patients with relapsed or refractory DLBCL and possibly lead to improved response rates and demonstrable clinical benefit. This trial will investigate the efficacy the combination of rituximab and gemcitabine in treating patients with relapsed or refractory DLBCL.

Timeline

Start
2005-04
Primary completion
2007-03
Completion
2007-03

Outcome

Outcome not reported

Stopped: “Study terminated due to lack of response at the first efficacy analysis”

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcitabine Small molecule 1000 mg/m2 —
Subject Rituximab Monoclonal antibody 375 mg/m2 —

Indications