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

Phase 2

Terminated

• Conditions: Lymphoma, Non-Hodgkin

• Registration Number: NCT00367497
• Lead Sponsor: Keio University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2006-08-22
• Study First Submitted QC: 2006-08-22
• Study First Posted: 2006-08-23
• Status Verified: 2007-11
• Study Completion: 2007-11
• Last Update Submitted: 2007-11-19
• Last Update Posted: 2007-11-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Clinical diagnosis of aggressive non-Hodgkin's lymphoma
• Refractory to the first line chemotherapy or relapsed
• Expression of CD20 on lymphoma cells
• Measurable lesions on imaging studies

Exclusion Criteria

• Blood cell counts not reaching to 3,000/microliter for white blood cells, 7 g/dl for hemoglobin, and 50,000/microliter for platelets without transfusion at the time of registration
• Circulating lymphoma cells equal to or more than 25,000/microliter
• Hepatic dysfunction
• Renal insufficiency
• Cardiac dysfunction or arrhythmia
• Sever infection (bacterial, viral)
• CNS involvement
• Other malignancies
• Pregnancy or breast feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Overall response

Secondary Outcome Measures

Name	Time	Method
Overall survival
Progression free survival
Effectiveness of peripheral blood stem cell collection
Complete response
Safety

Trial Locations

Locations (1)

Keio University School of Medicine; 🇯🇵 Tokyo, Japan