drugset / Trial / NCT00367497

Safety and Efficacy Study of Salvage Chemotherapy (R-ESHAP) to Treat Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma

NCT00367497 ↗

Phase 2 Terminated 5 enrolled Keio University
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Aggressive non-Hodgkin's lymphoma is difficult to handle once it relapses or becomes refractory to chemotherapy. Various second or third line chemotherapies, which are called salvage chemotherapy, were developed without promising results. Improvement in efficacy by adding relatively new agent, rituximab, to chemotherapy is now widely accepted in non-Hodgkin's lymphoma. This study will test the safety and efficacy of adding rituximab to existing salvage chemotherapy, ESHAP (R-ESHAP). Our aim is also to proceed to high-dose chemotherapy with autologous hematopoietic stem cell transplantation after successful R-ESHAP therapy.

Timeline

Start
2005-08
Primary completion
—
Completion
2007-11

Outcome

Outcome not reported

Stopped: “The stopping rule was applied because of low response rates.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Rituximab Monoclonal antibody — —
Background Cisplatin Other / unclassified — —
Background Cytarabine Small molecule — —
Background Etoposide Small molecule — —
Background Methylprednisolone Other / unclassified — —

Indications